Parent-Child RelationsNCT05834907

Hands and Hearts Together

A study testing Circle of Security Parenting and Little Talks in people with Parent-Child Relations and Development, Infant, run by University of Maryland, College Park at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 8 months and olderHealthy volunteers can take part
Conditions the study is for: Parent-Child Relations, Development, Infant, Parenting
What is being tested?: Circle of Security Parenting and Little Talks
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 249 participants
Where: 2 sitesUnited States
Study dates: 27 Mar 2023to 30 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Parents whose children (age 8 to 36 months) are enrolled or are eligible to be enrolled in Harrisburg PA and Lehigh Valley PA Early Head Start programs

Who cannot join

Parents who are not sufficiently fluent in the language in which COS-P intervention will be conducted (Spanish or English)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jude Cassidy, Ph.D. contact

301-405-4973

jcassidy@umd.edu

Susan Woodhouse, Ph.D. contact

610-758-3269

ssw212@lehigh.edu

United States2 sites, 1 recruiting

Lehigh University
Bethlehem, Pennsylvania, 18015
Susan Woodhouse, Ph.D., 610-758-3269, ssw212@lehigh.edu
Recruiting
University of Maryland, College Park
College Park, Maryland, 20742
Active, not recruiting

Other trials in United States

About this study

Official title: Prevention of Attachment Insecurity, Physiological Dysregulation, and Child Behavior Problems

Growing evidence demonstrates that secure attachment in childhood predicts children's healthy social, biological, and behavioral functioning, whereas insecure attachment predicts behavior problems and physiological dysregulation; thus, efforts to foster secure attachment are crucial for promoting the healthy development of children and families. This proposal describes a randomized controlled trial (RCT) of an innovative intervention program that can be widely implemented designed to foster children's secure attachment, promote healthy physiological regulation, and reduce the risk for behavior problems: The Circle of Security ® Parenting (COS-P) intervention. To this end, investigators will conduct an RCT with 249 parent-child dyads enrolled or are eligible but not yet enrolled in two diverse Early Head Start (EHS) programs.

Conditions: Parent-Child Relations, Development, Infant, Parenting, Development, Child
Being tested: Circle of Security Parenting, Little Talks
Keywords: Parent-Child Relations, Development, Infant, Parenting, Development, Child, Attachment, Home Visiting, Early Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Circle of Security ParentingBehavioural
COS-P is an attachment-based, home visiting intervention intended to supporting parents in serving as "a secure base" from which their children can explore the world, and to which their children can return in times of distress (Bowlby, 1988). Such secure base parenting increases the likelihood of children's secure attachment. COS-P also targets parental responses to children's expression of their needs (e.g., crying), and is designed to help parents understand the ways in which their own (parental) dysregulated emotional, physiological, and behavioral responses to children's emotions and behaviors can limit their responsiveness to their children's attachment needs.
Little TalksBehavioural
Little Talks is an early literacy home visiting intervention developed for low-income, racial and ethnic minority infants and toddlers, and has been tested in Early Head Start contexts (Manz et al., 2016; Manz et al. 2017). Little Talks uses book sharing to promote early literacy and has been adapted in both English and Spanish. The intervention utilizes modular treatments during home visits, teaching parents how to facilitate language interactions with their children through book sharing. Age appropriate books are given to parents to share with their children during the intervention.

Study groups in NCT05834907
Study group	Role	What they receive
Circle of Security Parenting (COS-P)	Experimental	These participants will receive the Circle of Security Parenting (COS-P) intervention, an attachment-based, manualized, 8-session (90 minutes/session), home visiting intervention. Receives: Behavioral: Circle of Security Parenting
Little Talks	Active comparator	These participants will receive the Little Talks intervention, a manualized, 8-session (90 minutes/session) early literacy home visiting intervention. Receives: Behavioral: Little Talks

What is being measured

The primary outcome is the main question the study is designed to answer.

Strange Situation Procedure (SSP) #1
Child-parent attachment for children aged 12-24 months will be assessed with Ainsworth's Strange Situation (Ainsworth et al., 1978) procedure. The 20-minute procedure consists of two infant-parent separations, and two reunions. Infant behavior is used to classify infants as secure or one of three types of insecure; continuous security scores can also be derived, and will be used in addition to classifications.
Measured: Baseline
Strange Situation Procedure (SSP) #2
Child-parent attachment for children aged 12-24 months will be assessed with Ainsworth's Strange Situation (Ainsworth et al., 1978) procedure. The 20-minute procedure consists of two infant-parent separations, and two reunions. Infant behavior is used to classify infants as secure or one of three types of insecure; continuous security scores can also be derived, and will be used in addition to classifications.
Measured: Immediately post-intervention
Strange Situation Procedure (SSP) #3
Child-parent attachment for children aged 12-24 months will be assessed with Ainsworth's Strange Situation (Ainsworth et al., 1978) procedure. The 20-minute procedure consists of two infant-parent separations, and two reunions. Infant behavior is used to classify infants as secure or one of three types of insecure; continuous security scores can also be derived, and will be used in addition to classifications.
Measured: 6-month follow up
Macarthur Preschool Strange Situation (PACS) #1
Child-parent attachment for children over 24-months will be assessed with the MacArthur Preschool Strange Situation (PACS; Cassidy et al., 1992; Solomon \& George, 2016), which also classifies children as secure or one of three types of insecure; continuous security scores on a scale of 1 to 7 can also be derived, and these (standardized) scores will be used along with classifications. This procedure consists of an initial 3-minute period in which both parent and child are in the toy-filled playroom, followed by two separations (3 and 5 minute) and two 3-minute reunions.
Measured: Baseline
Macarthur Preschool Strange Situation (PACS) #2
Child-parent attachment for children over 24-months will be assessed with the MacArthur Preschool Strange Situation (PACS; Cassidy et al., 1992; Solomon \& George, 2016), which also classifies children as secure or one of three types of insecure; continuous security scores on a scale of 1 to 7 can also be derived, and these (standardized) scores will be used along with classifications. This procedure consists of an initial 3-minute period in which both parent and child are in the toy-filled playroom, followed by two separations (3 and 5 minute) and two 3-minute reunions.
Measured: Immediately post-intervention
Macarthur Preschool Strange Situation (PACS) #3
Child-parent attachment for children over 24-months will be assessed with the MacArthur Preschool Strange Situation (PACS; Cassidy et al., 1992; Solomon \& George, 2016), which also classifies children as secure or one of three types of insecure; continuous security scores on a scale of 1 to 7 can also be derived, and these (standardized) scores will be used along with classifications. This procedure consists of an initial 3-minute period in which both parent and child are in the toy-filled playroom, followed by two separations (3 and 5 minute) and two 3-minute reunions.
Measured: 6-month follow up
Cortisol Stress Reactivity and Recovery #1
Cortisol stress reactivity and recovery will be assessed (following previous studies; e.g., Luijk et al., 2010) using the Strange Situation Procedure (SSP) as the stressor. Salivary samples will be collected (using a 125mm polymer swab) at baseline (pre-task), 10-, 20-, 30-, and 40-minutes post peak SSP stressor (i.e., end of separation 2), then frozen in tubes. Radioimmunoassay analysis will be done in duplicate, with the mean used as the final measure (in ug/dl). Labs will begin in the afternoon (between 1-4pm) to reduce potential diurnal effects. Multiple studies (e.g., Bernard \& Dozier, 2010; Thompson et al., 2015) demonstrated a lack of diurnal influence in infant cortisol studies, thus time of day will not be controlled. Cortisol may fluctuate with sleep/wake patterns and eating (Gunnar \& Herrera, 2013), so investigators will control for time of last waking and eating.
Measured: Baseline
Cortisol Stress Reactivity and Recovery #2
Cortisol stress reactivity and recovery will be assessed (following previous studies; e.g., Luijk et al., 2010) using the Strange Situation Procedure (SSP) as the stressor. Salivary samples will be collected (using a 125mm polymer swab) at baseline (pre-task), 10-, 20-, 30-, and 40-minutes post peak SSP stressor (i.e., end of separation 2), then frozen in tubes. Radioimmunoassay analysis will be done in duplicate, with the mean used as the final measure (in ug/dl). Labs will begin in the afternoon (between 1-4pm) to reduce potential diurnal effects. Multiple studies (e.g., Bernard \& Dozier, 2010; Thompson et al., 2015) demonstrated a lack of diurnal influence in infant cortisol studies, thus time of day will not be controlled. Cortisol may fluctuate with sleep/wake patterns and eating (Gunnar \& Herrera, 2013), so investigators will control for time of last waking and eating.
Measured: Immediately post-intervention
Cortisol Stress Reactivity and Recovery #3
Cortisol stress reactivity and recovery will be assessed (following previous studies; e.g., Luijk et al., 2010) using the Strange Situation Procedure (SSP) as the stressor. Salivary samples will be collected (using a 125mm polymer swab) at baseline (pre-task), 10-, 20-, 30-, and 40-minutes post peak SSP stressor (i.e., end of separation 2), then frozen in tubes. Radioimmunoassay analysis will be done in duplicate, with the mean used as the final measure (in ug/dl). Labs will begin in the afternoon (between 1-4pm) to reduce potential diurnal effects. Multiple studies (e.g., Bernard \& Dozier, 2010; Thompson et al., 2015) demonstrated a lack of diurnal influence in infant cortisol studies, thus time of day will not be controlled. Cortisol may fluctuate with sleep/wake patterns and eating (Gunnar \& Herrera, 2013), so investigators will control for time of last waking and eating.
Measured: 6-month follow up
Child Behavior Checklist (CBCL) #1
Child behavior problems will are assessed with the Child Behavior Checklist (version for 1.5- to 5-year-olds; CBCL; Achenbach \& Rescorla, 2000). Parents will complete this widely used 100-item questionnaire to report their children's internalizing (36 items, e.g., "is nervous, withdrawn") and externalizing (24 items, e.g., "is restless, disobedient") behavior problems. Responses are given on a 3-point scale: (0) not true, (1). somewhat/ sometimes true, (2) very/often true). Items are summed to create subscales for internalizing and externalizing problems.
Measured: Baseline
Child Behavior Checklist (CBCL) #2
Child behavior problems will are assessed with the Child Behavior Checklist (version for 1.5- to 5-year-olds; CBCL; Achenbach \& Rescorla, 2000). Parents will complete this widely used 100-item questionnaire to report their children's internalizing (36 items, e.g., "is nervous, withdrawn") and externalizing (24 items, e.g., "is restless, disobedient") behavior problems. Responses are given on a 3-point scale: (0) not true, (1). somewhat/ sometimes true, (2) very/often true). Items are summed to create subscales for internalizing and externalizing problems.
Measured: Immediately post-intervention
Child Behavior Checklist (CBCL) #3
Child behavior problems will are assessed with the Child Behavior Checklist (version for 1.5- to 5-year-olds; CBCL; Achenbach \& Rescorla, 2000). Parents will complete this widely used 100-item questionnaire to report their children's internalizing (36 items, e.g., "is nervous, withdrawn") and externalizing (24 items, e.g., "is restless, disobedient") behavior problems. Responses are given on a 3-point scale: (0) not true, (1). somewhat/ sometimes true, (2) very/often true). Items are summed to create subscales for internalizing and externalizing problems.
Measured: 6-month follow up
Infant-Toddler Social and Emotional Assessment (ITSEA) #1
Child behavior problems (from parent report) will be assessed with the ITSEA (Carter \& Briggs-Gowan, 2000; Carter et al., 2003) for children below the age of 1.5 years. The ITSEA assesses internalizing and externalizing symptoms. Parents will rate items on a scale of 0 (not true) to 2 (very true).
Measured: Baseline
Infant-Toddler Social and Emotional Assessment (ITSEA) #2
Child behavior problems (from parent report) will be assessed with the ITSEA (Carter \& Briggs-Gowan, 2000; Carter et al., 2003) for children below the age of 1.5 years. The ITSEA assesses internalizing and externalizing symptoms. Parents will rate items on a scale of 0 (not true) to 2 (very true).
Measured: Immediately post-intervention
Infant-Toddler Social and Emotional Assessment (ITSEA) #3
Child behavior problems (from parent report) will be assessed with the ITSEA (Carter \& Briggs-Gowan, 2000; Carter et al., 2003) for children below the age of 1.5 years. The ITSEA assesses internalizing and externalizing symptoms. Parents will rate items on a scale of 0 (not true) to 2 (very true).
Measured: 6-month follow up
Parental Emotional Responses to Child Distress #1
Parental emotional response to child distress will be assessed with the Crying Infant Video Task (Leerkes et al., 2004, 2011), in which parents watch four one-minute videos of (gender-neutral, racially diverse) infants in distress (i.e., crying loudly and continuously while sitting in a highchair). Following each clip, parents complete a questionnaire (4-point scale; 17 items) about their emotions while watching the clips, and elaborate about these emotions. Mean intensity scores are used to create a child-oriented empathic emotional response score (e.g., child-oriented sad, sympathy) and a parent-oriented negative emotions score (e.g., parent-oriented irritated, angry; see Leerkes, 2010).
Measured: Baseline
Parental Emotional Responses to Child Distress #2
Parental emotional response to child distress will be assessed with the Crying Infant Video Task (Leerkes et al., 2004, 2011), in which parents watch four one-minute videos of (gender-neutral, racially diverse) infants in distress (i.e., crying loudly and continuously while sitting in a highchair). Following each clip, parents complete a questionnaire (4-point scale; 17 items) about their emotions while watching the clips, and elaborate about these emotions. Mean intensity scores are used to create a child-oriented empathic emotional response score (e.g., child-oriented sad, sympathy) and a parent-oriented negative emotions score (e.g., parent-oriented irritated, angry; see Leerkes, 2010).
Measured: Immediately post-intervention
Parental Emotional Responses to Child Distress #3
Parental emotional response to child distress will be assessed with the Crying Infant Video Task (Leerkes et al., 2004, 2011), in which parents watch four one-minute videos of (gender-neutral, racially diverse) infants in distress (i.e., crying loudly and continuously while sitting in a highchair). Following each clip, parents complete a questionnaire (4-point scale; 17 items) about their emotions while watching the clips, and elaborate about these emotions. Mean intensity scores are used to create a child-oriented empathic emotional response score (e.g., child-oriented sad, sympathy) and a parent-oriented negative emotions score (e.g., parent-oriented irritated, angry; see Leerkes, 2010).
Measured: 6-month follow up
Electrodermal Activity (EDA) arousal #1
Parental EDA arousal in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA). For EDA investigators will attach two silver chloride electrodes to the palmar surface of the second phalanges of the index and middle fingers of each participant's non-dominant hand. EDA sample rate will be 1000 samples per second. Phasic skin conductance will be calculated using a smoothing filter with a window width of 0.25 seconds. Skin conductance responses (SCRs) will be calculated using a threshold of 0.05 µS. The EDA variable will be the sum the SCRs across the four videos.
Measured: Baseline
Electrodermal Activity (EDA) arousal #2
Parental EDA arousal in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA). For EDA investigators will attach two silver chloride electrodes to the palmar surface of the second phalanges of the index and middle fingers of each participant's non-dominant hand. EDA sample rate will be 1000 samples per second. Phasic skin conductance will be calculated using a smoothing filter with a window width of 0.25 seconds. Skin conductance responses (SCRs) will be calculated using a threshold of 0.05 µS. The EDA variable will be the sum the SCRs across the four videos.
Measured: Immediately post-intervention
Electrodermal Activity (EDA) arousal #3
Parental EDA arousal in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA). For EDA investigators will attach two silver chloride electrodes to the palmar surface of the second phalanges of the index and middle fingers of each participant's non-dominant hand. EDA sample rate will be 1000 samples per second. Phasic skin conductance will be calculated using a smoothing filter with a window width of 0.25 seconds. Skin conductance responses (SCRs) will be calculated using a threshold of 0.05 µS. The EDA variable will be the sum the SCRs across the four videos.
Measured: 6-month follow up
Respiratory Sinus Arrhythmia (RSA) #1
Parental RSA change in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA) and respiratory sinus arrhythmia (RSA). For RSA, investigators will attach three electrodes in a modified Lead II placement on the distal end of the right clavicle, lower left rib cage chest, and right rib cage of each parent's chest. The ECG signal will be sampled continuously with low-pass filtering at 1000 Hertz and passed through an Analog-to-Digital converter. RSA values will be derived from the interbeat interval series and resampled at 25 msec to create a stationary wave form. The integral of the power in the RSA band (0.12 to 0.40 for parents) will be extracted to obtain the RSA statistics in 30-second epochs, and will be used to calculate RSA change in response to infant distress.
Measured: Baseline
Respiratory Sinus Arrhythmia (RSA) #2
Parental RSA change in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA) and respiratory sinus arrhythmia (RSA). For RSA, investigators will attach three electrodes in a modified Lead II placement on the distal end of the right clavicle, lower left rib cage chest, and right rib cage of each parent's chest. The ECG signal will be sampled continuously with low-pass filtering at 1000 Hertz and passed through an Analog-to-Digital converter. RSA values will be derived from the interbeat interval series and resampled at 25 msec to create a stationary wave form. The integral of the power in the RSA band (0.12 to 0.40 for parents) will be extracted to obtain the RSA statistics in 30-second epochs, and will be used to calculate RSA change in response to infant distress.
Measured: Immediately post-intervention
Respiratory Sinus Arrhythmia (RSA) #3
Parental RSA change in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA) and respiratory sinus arrhythmia (RSA). For RSA, investigators will attach three electrodes in a modified Lead II placement on the distal end of the right clavicle, lower left rib cage chest, and right rib cage of each parent's chest. The ECG signal will be sampled continuously with low-pass filtering at 1000 Hertz and passed through an Analog-to-Digital converter. RSA values will be derived from the interbeat interval series and resampled at 25 msec to create a stationary wave form. The integral of the power in the RSA band (0.12 to 0.40 for parents) will be extracted to obtain the RSA statistics in 30-second epochs, and will be used to calculate RSA change in response to infant distress.
Measured: 6-month follow up
Coping with Toddlers' Negative Emotions Scale (CTNES) #1
Parental behavioral sensitivity in response to child distress will be assessed using the Coping With Toddlers' Negative Emotions Scale (CTNES; Spinrad et al., 2007), parents will report their likely behavior on a scale of 1 (very likely) to 7 (very unlikely) in response to 12 hypothetical situations with their distressed child (e.g., "If my child becomes upset and cries because he is left alone…, I would:"). For each item, parents report their likelihood of responding in six different ways, for instance punitive responses (i.e., punishing the child); minimizing responses (i.e., telling child to stop overreacting); emotion-focused reactions (i.e., comforting); and problem-focused reactions (i.e., helping child come up with solution). Following Gudmundson and Leerkes (2012), investigators will form supportive and unsupportive parental response composites.
Measured: Baseline
Coping with Toddlers' Negative Emotions Scale (CTNES) #2
Parental behavioral sensitivity in response to child distress will be assessed using the Coping With Toddlers' Negative Emotions Scale (CTNES; Spinrad et al., 2007), parents will report their likely behavior on a scale of 1 (very likely) to 7 (very unlikely) in response to 12 hypothetical situations with their distressed child (e.g., "If my child becomes upset and cries because he is left alone…, I would:"). For each item, parents report their likelihood of responding in six different ways, for instance punitive responses (i.e., punishing the child); minimizing responses (i.e., telling child to stop overreacting); emotion-focused reactions (i.e., comforting); and problem-focused reactions (i.e., helping child come up with solution). Following Gudmundson and Leerkes (2012), investigators will form supportive and unsupportive parental response composites.
Measured: Immediately post-intervention
Coping with Toddlers' Negative Emotions Scale (CTNES) #3
Parental behavioral sensitivity in response to child distress will be assessed using the Coping With Toddlers' Negative Emotions Scale (CTNES; Spinrad et al., 2007), parents will report their likely behavior on a scale of 1 (very likely) to 7 (very unlikely) in response to 12 hypothetical situations with their distressed child (e.g., "If my child becomes upset and cries because he is left alone…, I would:"). For each item, parents report their likelihood of responding in six different ways, for instance punitive responses (i.e., punishing the child); minimizing responses (i.e., telling child to stop overreacting); emotion-focused reactions (i.e., comforting); and problem-focused reactions (i.e., helping child come up with solution). Following Gudmundson and Leerkes (2012), investigators will form supportive and unsupportive parental response composites.
Measured: 6 month follow up
Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #1
Raters will observe parental behavioral sensitivity during the 'Stranger Approach' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness in children by having an adult stranger approach the child. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Measured: Baseline
Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #1
Raters will observe parental behavioral sensitivity during the 'Jar' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger in children by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Measured: Baseline
Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #2
Raters will observe parental behavioral sensitivity during the 'Stranger Approach' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness in children by having an adult stranger approach the child. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Measured: Immediately post-intervention
Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #2
Raters will observe parental behavioral sensitivity during the 'Jar' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger in children by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Measured: Immediately post-intervention
Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #3
Raters will observe parental behavioral sensitivity during the 'Stranger Approach' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness in children by having an adult stranger approach the child. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Measured: 6-month follow up
Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #3
Raters will observe parental behavioral sensitivity during the 'Jar' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger in children by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Measured: 6-month follow up

Secondary outcomes (26)

Financial Stress Questionnaire #1
The Financial Stress Questionnaire is a 9-item instrument, developed by the Fast Track project (CPPRG, 1994), which explores sources of household spending and adequacy of funds for paying bills. The questionnaire is administered to parents. The parent is asked to evaluate the affordability of 7 spending sources in the household (home, clothing, furniture, car, food, medical care and leisure) on a 1 to 5 scale (strongly agree, agree, neutral, disagree, strongly disagree); how much difficulty he/she had to pay the bills on a 1 to 5 scale (a great of difficulty to no difficulty at all) and how much money was left at the end of the month on a 1 to 4 scale (not enough, just enough, some money left, more than enough money left over).
Measured: Baseline
Financial Stress Questionnaire #2
The Financial Stress Questionnaire is a 9-item instrument, developed by the Fast Track project (CPPRG, 1994), which explores sources of household spending and adequacy of funds for paying bills. The questionnaire is administered to parents. The parent is asked to evaluate the affordability of 7 spending sources in the household (home, clothing, furniture, car, food, medical care and leisure) on a 1 to 5 scale (strongly agree, agree, neutral, disagree, strongly disagree); how much difficulty he/she had to pay the bills on a 1 to 5 scale (a great of difficulty to no difficulty at all) and how much money was left at the end of the month on a 1 to 4 scale (not enough, just enough, some money left, more than enough money left over).
Measured: Immediately post-intervention
Financial Stress Questionnaire #3
The Financial Stress Questionnaire is a 9-item instrument, developed by the Fast Track project (CPPRG, 1994), which explores sources of household spending and adequacy of funds for paying bills. The questionnaire is administered to parents. The parent is asked to evaluate the affordability of 7 spending sources in the household (home, clothing, furniture, car, food, medical care and leisure) on a 1 to 5 scale (strongly agree, agree, neutral, disagree, strongly disagree); how much difficulty he/she had to pay the bills on a 1 to 5 scale (a great of difficulty to no difficulty at all) and how much money was left at the end of the month on a 1 to 4 scale (not enough, just enough, some money left, more than enough money left over).
Measured: 6-month follow-up
O'Leary-Porter Overt Hostility Scale #1
Marital Stress will be assessed using the 10-item O'Leary-Porter Overt Hostility Scale, which measures how often parents openly argue, display physical and verbal hostility, and criticize each other in the presence of the children (Johnson \& O'Leary, 1987; Porter \& O'Leary, 1980). The scale uses a 6-point scale from 1 = never to 6 = very often. Investigators made slight modifications to this scale to reduce the focus on only marital relationships. Participants under 20 years of age will receive a 9-item version of this scale to avoid asking younger participants about experiences of witnessing physical violence.
Measured: Baseline
O'Leary-Porter Overt Hostility Scale #2
Marital Stress will be assessed using the 10-item O'Leary-Porter Overt Hostility Scale, which measures how often parents openly argue, display physical and verbal hostility, and criticize each other in the presence of the children (Johnson \& O'Leary, 1987; Porter \& O'Leary, 1980). The scale uses a 6-point scale from 1 = never to 6 = very often. Investigators made slight modifications to this scale to reduce the focus on only marital relationships. Participants under 20 years of age will receive a 9-item version of this scale to avoid asking younger participants about experiences of witnessing physical violence.
Measured: Immediately post-intervention
O'Leary-Porter Overt Hostility Scale #3
Marital Stress will be assessed using the 10-item O'Leary-Porter Overt Hostility Scale, which measures how often parents openly argue, display physical and verbal hostility, and criticize each other in the presence of the children (Johnson \& O'Leary, 1987; Porter \& O'Leary, 1980). The scale uses a 6-point scale from 1 = never to 6 = very often. Investigators made slight modifications to this scale to reduce the focus on only marital relationships. Participants under 20 years of age will receive a 9-item version of this scale to avoid asking younger participants about experiences of witnessing physical violence.
Measured: 6-month follow-up
Adverse Childhood Experiences Questionnaire (ACE-Q)
The Adverse Childhood Experience Questionnaire (ACE-Q; Felitti et al., 1998) is a brief rating scale that measures the number of adverse childhood experiences that occurred in the first 18 years of life. The ACE-Q has 9 yes/no items that count the number of adverse childhood experiences participants experienced in the first 18 years of their life. A sample item is "Did a parent or other adult in the household often swear at you, insult you, put you down, or humiliate you? OR act in a way that made you afraid that you might be physically hurt?" Participants indicate yes or no for each question, and if the answer is yes, then a score of 1 is entered for that item. The number of ACEs is the total number of questions for which the answer was yes. To avoid asking younger participants about experiences of physical or sexual abuse, this questionnaire will only be given to participants over 20 years of age.
Measured: Baseline
Role Overload #1
Following the recommendations of Thiagarajan et al. (2006), Reilly's (1982) 13-item Role Overload Scale will be adapted into a 6-item unidimensional scale assessing parents' feelings of being overwhelmed with parenting duties, juggling multiple obligations, and lacking time to rest or pursue desired activities (e.g., "I cannot ever seem to catch up"). Parents' scores indicating how often they agree with the corresponding statements, using a 7-point scale which ranges from 1 = Never to 7 = Always, will be averaged.
Measured: Baseline
Role Overload #2
Following the recommendations of Thiagarajan et al. (2006), Reilly's (1982) 13-item Role Overload Scale will be adapted into a 6-item unidimensional scale assessing parents' feelings of being overwhelmed with parenting duties, juggling multiple obligations, and lacking time to rest or pursue desired activities (e.g., "I cannot ever seem to catch up"). Parents' scores indicating how often they agree with the corresponding statements, using a 7-point scale which ranges from 1 = Never to 7 = Always, will be averaged.
Measured: Immediately post-intervention
Role Overload #3
Following the recommendations of Thiagarajan et al. (2006), Reilly's (1982) 13-item Role Overload Scale will be adapted into a 6-item unidimensional scale assessing parents' feelings of being overwhelmed with parenting duties, juggling multiple obligations, and lacking time to rest or pursue desired activities (e.g., "I cannot ever seem to catch up"). Parents' scores indicating how often they agree with the corresponding statements, using a 7-point scale which ranges from 1 = Never to 7 = Always, will be averaged.
Measured: 6-month follow-up
My Exposure to Violence
Witnessing community violence and violent victimization will be assessed using two subscales (victimization and witnessing) of the My Exposure to Violence (MyETV; Selner-O'Hagan et al., 1998). This is a 25-item instrument that was designed to measure participants' exposure to violence in the past year. The MyETV asks participants about witnessed as well as personally experienced violence, yielding three subscales (of which investigators will use two). The three subscales are witnessing violence, violent victimization, and total exposure. Frequency of exposure is measured on a 4-point scale (once, 2 or 3 times, 4 to 10 times, more than 10 times). To avoid asking questions about childhood physical or sexual abuse, this questionnaire will only be given to participants over 20 years of age.
Measured: Baseline
Experiences in Close Relationships Scale (ECR) #1
Adult attachment style will be assessed with the 36-item self-report Experiences in Close Relationships Scale (ECR; Brennan, Clark, \& Shaver, 1998; see Mikulincer \& Shaver, 2016). The ECR assesses two dimensions of adult attachment style: attachment related avoidance (discomfort with closeness and intimacy) and attachment related anxiety (intense fear of rejection and abandonment) each on a scale of 1 (low) to 7 (high).
Measured: Baseline
Experiences in Close Relationships Scale (ECR) #2
Adult attachment style will be assessed with the 36-item self-report Experiences in Close Relationships Scale (ECR; Brennan, Clark, \& Shaver, 1998; see Mikulincer \& Shaver, 2016). The ECR assesses two dimensions of adult attachment style: attachment related avoidance (discomfort with closeness and intimacy) and attachment related anxiety (intense fear of rejection and abandonment) each on a scale of 1 (low) to 7 (high).
Measured: Immediately post-intervention
Experiences in Close Relationships Scale (ECR) #3
Adult attachment style will be assessed with the 36-item self-report Experiences in Close Relationships Scale (ECR; Brennan, Clark, \& Shaver, 1998; see Mikulincer \& Shaver, 2016). The ECR assesses two dimensions of adult attachment style: attachment related avoidance (discomfort with closeness and intimacy) and attachment related anxiety (intense fear of rejection and abandonment) each on a scale of 1 (low) to 7 (high).
Measured: 6-month follow-up
Center for Epidemiologic Studies Depression Scale (CES-D) #1
Parental depressive symptoms will be assessed with the CES-D (Radloff, 1977). This 20-item self-report measure (Radloff, 1977) taps the frequency with which respondents experienced depressive symptoms over the past week. Responses are given on a 4-point scale, with 0 indicating that the symptom was rarely or never felt, and 3 indicating that it was experienced most or all of the time.
Measured: Baseline
Center for Epidemiologic Studies Depression Scale (CES-D) #2
Parental depressive symptoms will be assessed with the CES-D (Radloff, 1977). This 20-item self-report measure (Radloff, 1977) taps the frequency with which respondents experienced depressive symptoms over the past week. Responses are given on a 4-point scale, with 0 indicating that the symptom was rarely or never felt, and 3 indicating that it was experienced most or all of the time.
Measured: Immediately post-intervention
Center for Epidemiologic Studies Depression Scale (CES-D) #3
Parental depressive symptoms will be assessed with the CES-D (Radloff, 1977). This 20-item self-report measure (Radloff, 1977) taps the frequency with which respondents experienced depressive symptoms over the past week. Responses are given on a 4-point scale, with 0 indicating that the symptom was rarely or never felt, and 3 indicating that it was experienced most or all of the time.
Measured: 6-month follow-up
Child Behavior Questionnaire
Parents will complete the age appropriate version of the Child Behavior Questionnaires designed by Rothbart \& colleagues (e.g., Putnam \& Rothbart, 2006). This questionnaire assesses child temperamental reactivity and child fearful temperament.
Measured: Baseline
Stranger Approach Lab-TAB Task to assess child temperament
Raters will observe child temperament during the 'Stranger Approach' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness by having an adult stranger approach and stare at the child in a standardized fashion. The elements of novelty and intrusiveness should elicit various degrees of fearful distress and avoidance. This task lasts approximately 1-2 minutes.
Measured: Baseline
Behind Barrier Lab-TAB Task to assess child temperament
Raters will observe child temperament during the 'Behind Barrier' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger by placing a toy, with which the child has been playing, behind a barrier. Anger is coded as verbal and physical action against the barrier or persons present. This task lasts approximately 3 minutes.
Measured: Baseline
Jar Lab-TAB Task to assess child temperament
Raters will observe child temperament during the 'Jar' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This action is representative of the type of frustration a child typically encounters when exploration or play is blocked. Anger is coded as verbal and physical action against the jar or persons present. This task lasts approximately 1-2 minutes.
Measured: Baseline
Spider Lab-TAB Task to assess child temperament
Raters will observe child temperament during the 'Spider' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness by having a toy spider unexpectedly approach the child. The elements of novelty, uncertainty and intrusiveness, as well as a possible fear of animals, should elicit varying degrees of fear. This task lasts approximately 2-3 minutes.
Measured: Baseline
Infant Behavior Record (IBR) assessing child temperament #1
Two trained observers will use the Infant Behavior Record (IBR; Bayley, 1969; Stifter \& Corey, 2001; Stifter et al., 2008) to assess 11 dimensions of child temperament based on their observations of the entire lab session.
Measured: Baseline
Infant Behavior Record (IBR) assessing child temperament #2
Two trained observers will use the Infant Behavior Record (IBR; Bayley, 1969; Stifter \& Corey, 2001; Stifter et al., 2008) to assess 11 dimensions of child temperament based on their observations of the entire lab session.
Measured: Immediately post-intervention
Infant Behavior Record (IBR) assessing child temperament #3
Two trained observers will use the Infant Behavior Record (IBR; Bayley, 1969; Stifter \& Corey, 2001; Stifter et al., 2008) to assess 11 dimensions of child temperament based on their observations of the entire lab session.
Measured: 6-month follow-up
Experience of Discrimination Scale (EOD)
Participants' lifetime experience with discrimination will be assessed using the 9-item self-report Experience of Discrimination Scale (EOD; Krieger, 1990; Krieger \& Sidney, 1996; Krieger et al., 2005). Following Krieger et al. (2005), investigators included an additional 4 questions about participants' level of worry about experiencing unfair treatment due to their race or ethnicity.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 202330 Jun 2027

First posted28 Apr 2023
Study start27 Mar 2023
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (41)Papers the sponsor has linked to this study.
Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 249 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05834907
Sponsor's protocol ID: 1857396-18
Other IDs: 1R01HD105676-01A1
Status last verified: Jun 2025
First submitted: 24 Mar 2023
Last updated: 3 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Achenbach, T. M., & Rescorla, L. A. (2000). Manual for the ASEBA Preschool Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
Ainsworth, M., Blehar, M., Waters, E., & Wall, S. (1978). Patterns of attachment. Erlbaum.
Bayley, N. 1969. Bayley scales of infant development. New York: Psychological Corp.
Bernard K, Dozier M. Examining infants' cortisol responses to laboratory tasks among children varying in attachment disorganization: stress reactivity or return to baseline? Dev Psychol. 2010 Nov;46(6):1771-8. doi: 10.1037/a0020660.
PubMed 20873923
Bowlby, J. (1988). A secure base. Basic Books.
Brennan, K. A., Clark, C. L., & Shaver, P. R. (1998). Self-report measurement of adult attachment: An integrative overview. In J. A. Simpson, W. S. Rholes, J. A. Simpson, W. S. Rholes (Eds.), Attachment theory and close relationships (pp. 46-76). Guilford.
Carroll KM, Nich C, Sifry RL, Nuro KF, Frankforter TL, Ball SA, Fenton L, Rounsaville BJ. A general system for evaluating therapist adherence and competence in psychotherapy research in the addictions. Drug Alcohol Depend. 2000 Jan 1;57(3):225-38. doi: 10.1016/s0376-8716(99)00049-6.
PubMed 10661673
Carter, A. S., & Briggs-Gowan, M. J. (2000). The Infant-Toddler Social and Emotional Assessment (ITSEA). Unpublished Manual. University of Massachusetts Boston Department of Psychology, Boston, MA. Yale University, New Haven, CT. Available by request at alice.carter@umb.edu.
Carter AS, Briggs-Gowan MJ, Jones SM, Little TD. The Infant-Toddler Social and Emotional Assessment (ITSEA): factor structure, reliability, and validity. J Abnorm Child Psychol. 2003 Oct;31(5):495-514. doi: 10.1023/a:1025449031360.
PubMed 14561058
Cassidy, J., & Marvin, R. S., with MacArthur Attachment Working Group (1992). Attachment organization in preschool children: Procedures and coding manual (4th ed.). Unpublished manuscript, Department of Psychology, University of Virginia, Charlottesville, Virginia.
Conduct Problems Prevention Research Group (CPPRG). (1994). Financial Stress Questionnaire. Available from the Fast Track Project Web site: http://www.fasttrackproject.org
Corrigan, J., & Schmidt, L. (1983). Development and validation of revisions in the Counselor Rating Form. Journal of Counseling Psychology, 30, 64-75. doi: 10.1037/0022-0167.30.1.64
Felitti, V. J., Anda, R. F., Nordenberg, D., & Williamson, D. F. (1998). Adverse childhood experiences and health outcomes in adults: The Ace study. Journal of Family and Consumer Sciences, 90, 31.
Goldsmith, H. H., & Rothbart, M. K. (1999). The Laboratory Temperament Assessment Battery. Locomotor Version 3.1, Description of Procedures. University of Wisconsin, Madison, WI.
Gudmundson JA, Leerkes EM. Links between mothers' coping styles, toddler reactivity, and sensitivity to toddler's negative emotions. Infant Behav Dev. 2012 Feb;35(1):158-66. doi: 10.1016/j.infbeh.2011.07.004. Epub 2011 Sep 7.
PubMed 21903276

Interested in taking part?

Jude Cassidy, Ph.D.

301-405-4973

jcassidy@umd.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Parent-Child Relations trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Attachment Insecurity, Physiological Dysregulation, and Child Behavior Problems
ClinicalTrials.gov ID: NCT05834907
Acronym / sponsor ID: 1857396-18
Conditions: Parent-Child Relations, Development, Infant, Parenting, Development, Child
Keywords: Parent-Child Relations, Development, Infant, Parenting, Development, Child, Attachment, Home Visiting, Early Intervention
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 249 participants (estimated)
Lead sponsor: University of Maryland, College ParkUniversity, hospital or other
Collaborators: Lehigh University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 27 Mar 2023 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 28 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Circle of Security Parenting (COS-P)	Experimental	Behavioral: Circle of Security ParentingThese participants will receive the Circle of Security Parenting (COS-P) intervention, an attachment-based, manualized, 8-session (90 minutes/session), home visiting intervention.
Little Talks	Active comparator	Behavioral: Little TalksThese participants will receive the Little Talks intervention, a manualized, 8-session (90 minutes/session) early literacy home visiting intervention.

Who may qualify

Ages: 8 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Parents whose children (age 8 to 36 months) are enrolled or are eligible to be enrolled in Harrisburg PA and Lehigh Valley PA Early Head Start programs

Key exclusion criteria (1 listed)

Parents who are not sufficiently fluent in the language in which COS-P intervention will be conducted (Spanish or English)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Circle of Security ParentingCOS-P is an attachment-based, home visiting intervention intended to supporting parents in serving as "a secure base" from which their children can explore the world, and to which their children can return in times of distress (Bowlby, 1988). Such secure base parenting increases the likelihood of children's secure attachment. COS-P also targets parental responses to children's expression of their needs (e.g., crying), and is designed to help parents understand the ways in which their own (parental) dysregulated emotional, physiological, and behavioral responses to children's emotions and behaviors can limit their responsiveness to their children's attachment needs.	Behavioural	Circle of Security Parenting (COS-P)
Little TalksLittle Talks is an early literacy home visiting intervention developed for low-income, racial and ethnic minority infants and toddlers, and has been tested in Early Head Start contexts (Manz et al., 2016; Manz et al. 2017). Little Talks uses book sharing to promote early literacy and has been adapted in both English and Spanish. The intervention utilizes modular treatments during home visits, teaching parents how to facilitate language interactions with their children through book sharing. Age appropriate books are given to parents to share with their children during the intervention.	Behavioural	Little Talks

Primary outcome

Strange Situation Procedure (SSP) #1
Time frame: Baseline
Child-parent attachment for children aged 12-24 months will be assessed with Ainsworth's Strange Situation (Ainsworth et al., 1978) procedure. The 20-minute procedure consists of two infant-parent separations, and two reunions. Infant behavior is used to classify infants as secure or one of three types of insecure; continuous security scores can also be derived, and will be used in addition to classifications.
Strange Situation Procedure (SSP) #2
Time frame: Immediately post-intervention
Child-parent attachment for children aged 12-24 months will be assessed with Ainsworth's Strange Situation (Ainsworth et al., 1978) procedure. The 20-minute procedure consists of two infant-parent separations, and two reunions. Infant behavior is used to classify infants as secure or one of three types of insecure; continuous security scores can also be derived, and will be used in addition to classifications.
Strange Situation Procedure (SSP) #3
Time frame: 6-month follow up
Child-parent attachment for children aged 12-24 months will be assessed with Ainsworth's Strange Situation (Ainsworth et al., 1978) procedure. The 20-minute procedure consists of two infant-parent separations, and two reunions. Infant behavior is used to classify infants as secure or one of three types of insecure; continuous security scores can also be derived, and will be used in addition to classifications.
Macarthur Preschool Strange Situation (PACS) #1
Time frame: Baseline
Child-parent attachment for children over 24-months will be assessed with the MacArthur Preschool Strange Situation (PACS; Cassidy et al., 1992; Solomon \& George, 2016), which also classifies children as secure or one of three types of insecure; continuous security scores on a scale of 1 to 7 can also be derived, and these (standardized) scores will be used along with classifications. This procedure consists of an initial 3-minute period in which both parent and child are in the toy-filled playroom, followed by two separations (3 and 5 minute) and two 3-minute reunions.
Macarthur Preschool Strange Situation (PACS) #2
Time frame: Immediately post-intervention
Child-parent attachment for children over 24-months will be assessed with the MacArthur Preschool Strange Situation (PACS; Cassidy et al., 1992; Solomon \& George, 2016), which also classifies children as secure or one of three types of insecure; continuous security scores on a scale of 1 to 7 can also be derived, and these (standardized) scores will be used along with classifications. This procedure consists of an initial 3-minute period in which both parent and child are in the toy-filled playroom, followed by two separations (3 and 5 minute) and two 3-minute reunions.
Macarthur Preschool Strange Situation (PACS) #3
Time frame: 6-month follow up
Child-parent attachment for children over 24-months will be assessed with the MacArthur Preschool Strange Situation (PACS; Cassidy et al., 1992; Solomon \& George, 2016), which also classifies children as secure or one of three types of insecure; continuous security scores on a scale of 1 to 7 can also be derived, and these (standardized) scores will be used along with classifications. This procedure consists of an initial 3-minute period in which both parent and child are in the toy-filled playroom, followed by two separations (3 and 5 minute) and two 3-minute reunions.
Cortisol Stress Reactivity and Recovery #1
Time frame: Baseline
Cortisol stress reactivity and recovery will be assessed (following previous studies; e.g., Luijk et al., 2010) using the Strange Situation Procedure (SSP) as the stressor. Salivary samples will be collected (using a 125mm polymer swab) at baseline (pre-task), 10-, 20-, 30-, and 40-minutes post peak SSP stressor (i.e., end of separation 2), then frozen in tubes. Radioimmunoassay analysis will be done in duplicate, with the mean used as the final measure (in ug/dl). Labs will begin in the afternoon (between 1-4pm) to reduce potential diurnal effects. Multiple studies (e.g., Bernard \& Dozier, 2010; Thompson et al., 2015) demonstrated a lack of diurnal influence in infant cortisol studies, thus time of day will not be controlled. Cortisol may fluctuate with sleep/wake patterns and eating (Gunnar \& Herrera, 2013), so investigators will control for time of last waking and eating.
Cortisol Stress Reactivity and Recovery #2
Time frame: Immediately post-intervention
Cortisol stress reactivity and recovery will be assessed (following previous studies; e.g., Luijk et al., 2010) using the Strange Situation Procedure (SSP) as the stressor. Salivary samples will be collected (using a 125mm polymer swab) at baseline (pre-task), 10-, 20-, 30-, and 40-minutes post peak SSP stressor (i.e., end of separation 2), then frozen in tubes. Radioimmunoassay analysis will be done in duplicate, with the mean used as the final measure (in ug/dl). Labs will begin in the afternoon (between 1-4pm) to reduce potential diurnal effects. Multiple studies (e.g., Bernard \& Dozier, 2010; Thompson et al., 2015) demonstrated a lack of diurnal influence in infant cortisol studies, thus time of day will not be controlled. Cortisol may fluctuate with sleep/wake patterns and eating (Gunnar \& Herrera, 2013), so investigators will control for time of last waking and eating.
Cortisol Stress Reactivity and Recovery #3
Time frame: 6-month follow up
Cortisol stress reactivity and recovery will be assessed (following previous studies; e.g., Luijk et al., 2010) using the Strange Situation Procedure (SSP) as the stressor. Salivary samples will be collected (using a 125mm polymer swab) at baseline (pre-task), 10-, 20-, 30-, and 40-minutes post peak SSP stressor (i.e., end of separation 2), then frozen in tubes. Radioimmunoassay analysis will be done in duplicate, with the mean used as the final measure (in ug/dl). Labs will begin in the afternoon (between 1-4pm) to reduce potential diurnal effects. Multiple studies (e.g., Bernard \& Dozier, 2010; Thompson et al., 2015) demonstrated a lack of diurnal influence in infant cortisol studies, thus time of day will not be controlled. Cortisol may fluctuate with sleep/wake patterns and eating (Gunnar \& Herrera, 2013), so investigators will control for time of last waking and eating.
Child Behavior Checklist (CBCL) #1
Time frame: Baseline
Child behavior problems will are assessed with the Child Behavior Checklist (version for 1.5- to 5-year-olds; CBCL; Achenbach \& Rescorla, 2000). Parents will complete this widely used 100-item questionnaire to report their children's internalizing (36 items, e.g., "is nervous, withdrawn") and externalizing (24 items, e.g., "is restless, disobedient") behavior problems. Responses are given on a 3-point scale: (0) not true, (1). somewhat/ sometimes true, (2) very/often true). Items are summed to create subscales for internalizing and externalizing problems.
Child Behavior Checklist (CBCL) #2
Time frame: Immediately post-intervention
Child behavior problems will are assessed with the Child Behavior Checklist (version for 1.5- to 5-year-olds; CBCL; Achenbach \& Rescorla, 2000). Parents will complete this widely used 100-item questionnaire to report their children's internalizing (36 items, e.g., "is nervous, withdrawn") and externalizing (24 items, e.g., "is restless, disobedient") behavior problems. Responses are given on a 3-point scale: (0) not true, (1). somewhat/ sometimes true, (2) very/often true). Items are summed to create subscales for internalizing and externalizing problems.
Child Behavior Checklist (CBCL) #3
Time frame: 6-month follow up
Child behavior problems will are assessed with the Child Behavior Checklist (version for 1.5- to 5-year-olds; CBCL; Achenbach \& Rescorla, 2000). Parents will complete this widely used 100-item questionnaire to report their children's internalizing (36 items, e.g., "is nervous, withdrawn") and externalizing (24 items, e.g., "is restless, disobedient") behavior problems. Responses are given on a 3-point scale: (0) not true, (1). somewhat/ sometimes true, (2) very/often true). Items are summed to create subscales for internalizing and externalizing problems.
Infant-Toddler Social and Emotional Assessment (ITSEA) #1
Time frame: Baseline
Child behavior problems (from parent report) will be assessed with the ITSEA (Carter \& Briggs-Gowan, 2000; Carter et al., 2003) for children below the age of 1.5 years. The ITSEA assesses internalizing and externalizing symptoms. Parents will rate items on a scale of 0 (not true) to 2 (very true).
Infant-Toddler Social and Emotional Assessment (ITSEA) #2
Time frame: Immediately post-intervention
Child behavior problems (from parent report) will be assessed with the ITSEA (Carter \& Briggs-Gowan, 2000; Carter et al., 2003) for children below the age of 1.5 years. The ITSEA assesses internalizing and externalizing symptoms. Parents will rate items on a scale of 0 (not true) to 2 (very true).
Infant-Toddler Social and Emotional Assessment (ITSEA) #3
Time frame: 6-month follow up
Child behavior problems (from parent report) will be assessed with the ITSEA (Carter \& Briggs-Gowan, 2000; Carter et al., 2003) for children below the age of 1.5 years. The ITSEA assesses internalizing and externalizing symptoms. Parents will rate items on a scale of 0 (not true) to 2 (very true).
Parental Emotional Responses to Child Distress #1
Time frame: Baseline
Parental emotional response to child distress will be assessed with the Crying Infant Video Task (Leerkes et al., 2004, 2011), in which parents watch four one-minute videos of (gender-neutral, racially diverse) infants in distress (i.e., crying loudly and continuously while sitting in a highchair). Following each clip, parents complete a questionnaire (4-point scale; 17 items) about their emotions while watching the clips, and elaborate about these emotions. Mean intensity scores are used to create a child-oriented empathic emotional response score (e.g., child-oriented sad, sympathy) and a parent-oriented negative emotions score (e.g., parent-oriented irritated, angry; see Leerkes, 2010).
Parental Emotional Responses to Child Distress #2
Time frame: Immediately post-intervention
Parental emotional response to child distress will be assessed with the Crying Infant Video Task (Leerkes et al., 2004, 2011), in which parents watch four one-minute videos of (gender-neutral, racially diverse) infants in distress (i.e., crying loudly and continuously while sitting in a highchair). Following each clip, parents complete a questionnaire (4-point scale; 17 items) about their emotions while watching the clips, and elaborate about these emotions. Mean intensity scores are used to create a child-oriented empathic emotional response score (e.g., child-oriented sad, sympathy) and a parent-oriented negative emotions score (e.g., parent-oriented irritated, angry; see Leerkes, 2010).
Parental Emotional Responses to Child Distress #3
Time frame: 6-month follow up
Parental emotional response to child distress will be assessed with the Crying Infant Video Task (Leerkes et al., 2004, 2011), in which parents watch four one-minute videos of (gender-neutral, racially diverse) infants in distress (i.e., crying loudly and continuously while sitting in a highchair). Following each clip, parents complete a questionnaire (4-point scale; 17 items) about their emotions while watching the clips, and elaborate about these emotions. Mean intensity scores are used to create a child-oriented empathic emotional response score (e.g., child-oriented sad, sympathy) and a parent-oriented negative emotions score (e.g., parent-oriented irritated, angry; see Leerkes, 2010).
Electrodermal Activity (EDA) arousal #1
Time frame: Baseline
Parental EDA arousal in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA). For EDA investigators will attach two silver chloride electrodes to the palmar surface of the second phalanges of the index and middle fingers of each participant's non-dominant hand. EDA sample rate will be 1000 samples per second. Phasic skin conductance will be calculated using a smoothing filter with a window width of 0.25 seconds. Skin conductance responses (SCRs) will be calculated using a threshold of 0.05 µS. The EDA variable will be the sum the SCRs across the four videos.
Electrodermal Activity (EDA) arousal #2
Time frame: Immediately post-intervention
Parental EDA arousal in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA). For EDA investigators will attach two silver chloride electrodes to the palmar surface of the second phalanges of the index and middle fingers of each participant's non-dominant hand. EDA sample rate will be 1000 samples per second. Phasic skin conductance will be calculated using a smoothing filter with a window width of 0.25 seconds. Skin conductance responses (SCRs) will be calculated using a threshold of 0.05 µS. The EDA variable will be the sum the SCRs across the four videos.
Electrodermal Activity (EDA) arousal #3
Time frame: 6-month follow up
Parental EDA arousal in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA). For EDA investigators will attach two silver chloride electrodes to the palmar surface of the second phalanges of the index and middle fingers of each participant's non-dominant hand. EDA sample rate will be 1000 samples per second. Phasic skin conductance will be calculated using a smoothing filter with a window width of 0.25 seconds. Skin conductance responses (SCRs) will be calculated using a threshold of 0.05 µS. The EDA variable will be the sum the SCRs across the four videos.
Respiratory Sinus Arrhythmia (RSA) #1
Time frame: Baseline
Parental RSA change in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA) and respiratory sinus arrhythmia (RSA). For RSA, investigators will attach three electrodes in a modified Lead II placement on the distal end of the right clavicle, lower left rib cage chest, and right rib cage of each parent's chest. The ECG signal will be sampled continuously with low-pass filtering at 1000 Hertz and passed through an Analog-to-Digital converter. RSA values will be derived from the interbeat interval series and resampled at 25 msec to create a stationary wave form. The integral of the power in the RSA band (0.12 to 0.40 for parents) will be extracted to obtain the RSA statistics in 30-second epochs, and will be used to calculate RSA change in response to infant distress.
Respiratory Sinus Arrhythmia (RSA) #2
Time frame: Immediately post-intervention
Parental RSA change in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA) and respiratory sinus arrhythmia (RSA). For RSA, investigators will attach three electrodes in a modified Lead II placement on the distal end of the right clavicle, lower left rib cage chest, and right rib cage of each parent's chest. The ECG signal will be sampled continuously with low-pass filtering at 1000 Hertz and passed through an Analog-to-Digital converter. RSA values will be derived from the interbeat interval series and resampled at 25 msec to create a stationary wave form. The integral of the power in the RSA band (0.12 to 0.40 for parents) will be extracted to obtain the RSA statistics in 30-second epochs, and will be used to calculate RSA change in response to infant distress.
Respiratory Sinus Arrhythmia (RSA) #3
Time frame: 6-month follow up
Parental RSA change in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA) and respiratory sinus arrhythmia (RSA). For RSA, investigators will attach three electrodes in a modified Lead II placement on the distal end of the right clavicle, lower left rib cage chest, and right rib cage of each parent's chest. The ECG signal will be sampled continuously with low-pass filtering at 1000 Hertz and passed through an Analog-to-Digital converter. RSA values will be derived from the interbeat interval series and resampled at 25 msec to create a stationary wave form. The integral of the power in the RSA band (0.12 to 0.40 for parents) will be extracted to obtain the RSA statistics in 30-second epochs, and will be used to calculate RSA change in response to infant distress.
Coping with Toddlers' Negative Emotions Scale (CTNES) #1
Time frame: Baseline
Parental behavioral sensitivity in response to child distress will be assessed using the Coping With Toddlers' Negative Emotions Scale (CTNES; Spinrad et al., 2007), parents will report their likely behavior on a scale of 1 (very likely) to 7 (very unlikely) in response to 12 hypothetical situations with their distressed child (e.g., "If my child becomes upset and cries because he is left alone…, I would:"). For each item, parents report their likelihood of responding in six different ways, for instance punitive responses (i.e., punishing the child); minimizing responses (i.e., telling child to stop overreacting); emotion-focused reactions (i.e., comforting); and problem-focused reactions (i.e., helping child come up with solution). Following Gudmundson and Leerkes (2012), investigators will form supportive and unsupportive parental response composites.
Coping with Toddlers' Negative Emotions Scale (CTNES) #2
Time frame: Immediately post-intervention
Parental behavioral sensitivity in response to child distress will be assessed using the Coping With Toddlers' Negative Emotions Scale (CTNES; Spinrad et al., 2007), parents will report their likely behavior on a scale of 1 (very likely) to 7 (very unlikely) in response to 12 hypothetical situations with their distressed child (e.g., "If my child becomes upset and cries because he is left alone…, I would:"). For each item, parents report their likelihood of responding in six different ways, for instance punitive responses (i.e., punishing the child); minimizing responses (i.e., telling child to stop overreacting); emotion-focused reactions (i.e., comforting); and problem-focused reactions (i.e., helping child come up with solution). Following Gudmundson and Leerkes (2012), investigators will form supportive and unsupportive parental response composites.
Coping with Toddlers' Negative Emotions Scale (CTNES) #3
Time frame: 6 month follow up
Parental behavioral sensitivity in response to child distress will be assessed using the Coping With Toddlers' Negative Emotions Scale (CTNES; Spinrad et al., 2007), parents will report their likely behavior on a scale of 1 (very likely) to 7 (very unlikely) in response to 12 hypothetical situations with their distressed child (e.g., "If my child becomes upset and cries because he is left alone…, I would:"). For each item, parents report their likelihood of responding in six different ways, for instance punitive responses (i.e., punishing the child); minimizing responses (i.e., telling child to stop overreacting); emotion-focused reactions (i.e., comforting); and problem-focused reactions (i.e., helping child come up with solution). Following Gudmundson and Leerkes (2012), investigators will form supportive and unsupportive parental response composites.
Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #1
Time frame: Baseline
Raters will observe parental behavioral sensitivity during the 'Stranger Approach' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness in children by having an adult stranger approach the child. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #1
Time frame: Baseline
Raters will observe parental behavioral sensitivity during the 'Jar' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger in children by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #2
Time frame: Immediately post-intervention
Raters will observe parental behavioral sensitivity during the 'Stranger Approach' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness in children by having an adult stranger approach the child. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #2
Time frame: Immediately post-intervention
Raters will observe parental behavioral sensitivity during the 'Jar' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger in children by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #3
Time frame: 6-month follow up
Raters will observe parental behavioral sensitivity during the 'Stranger Approach' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness in children by having an adult stranger approach the child. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.
Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #3
Time frame: 6-month follow up
Raters will observe parental behavioral sensitivity during the 'Jar' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger in children by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.

26 secondary outcomes

Financial Stress Questionnaire #1
Time frame: Baseline
Financial Stress Questionnaire #2
Time frame: Immediately post-intervention
Financial Stress Questionnaire #3
Time frame: 6-month follow-up
O'Leary-Porter Overt Hostility Scale #1
Time frame: Baseline
O'Leary-Porter Overt Hostility Scale #2
Time frame: Immediately post-intervention
O'Leary-Porter Overt Hostility Scale #3
Time frame: 6-month follow-up
Adverse Childhood Experiences Questionnaire (ACE-Q)
Time frame: Baseline
Role Overload #1
Time frame: Baseline
Role Overload #2
Time frame: Immediately post-intervention
Role Overload #3
Time frame: 6-month follow-up
My Exposure to Violence
Time frame: Baseline
Experiences in Close Relationships Scale (ECR) #1
Time frame: Baseline
Experiences in Close Relationships Scale (ECR) #2
Time frame: Immediately post-intervention
Experiences in Close Relationships Scale (ECR) #3
Time frame: 6-month follow-up
Center for Epidemiologic Studies Depression Scale (CES-D) #1
Time frame: Baseline
Center for Epidemiologic Studies Depression Scale (CES-D) #2
Time frame: Immediately post-intervention
Center for Epidemiologic Studies Depression Scale (CES-D) #3
Time frame: 6-month follow-up
Child Behavior Questionnaire
Time frame: Baseline
Stranger Approach Lab-TAB Task to assess child temperament
Time frame: Baseline
Behind Barrier Lab-TAB Task to assess child temperament
Time frame: Baseline
Jar Lab-TAB Task to assess child temperament
Time frame: Baseline
Spider Lab-TAB Task to assess child temperament
Time frame: Baseline
Infant Behavior Record (IBR) assessing child temperament #1
Time frame: Baseline
Infant Behavior Record (IBR) assessing child temperament #2
Time frame: Immediately post-intervention
Infant Behavior Record (IBR) assessing child temperament #3
Time frame: 6-month follow-up
Experience of Discrimination Scale (EOD)
Time frame: Baseline

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
BackgroundAchenbach, T. M., & Rescorla, L. A. (2000). Manual for the ASEBA Preschool Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
BackgroundAinsworth, M., Blehar, M., Waters, E., & Wall, S. (1978). Patterns of attachment. Erlbaum.
BackgroundBayley, N. 1969. Bayley scales of infant development. New York: Psychological Corp.
Background: PubMed 20873923Bernard K, Dozier M. Examining infants' cortisol responses to laboratory tasks among children varying in attachment disorganization: stress reactivity or return to baseline? Dev Psychol. 2010 Nov;46(6):1771-8. doi: 10.1037/a0020660.
BackgroundBowlby, J. (1988). A secure base. Basic Books.
BackgroundBrennan, K. A., Clark, C. L., & Shaver, P. R. (1998). Self-report measurement of adult attachment: An integrative overview. In J. A. Simpson, W. S. Rholes, J. A. Simpson, W. S. Rholes (Eds.), Attachment theory and close relationships (pp. 46-76). Guilford.
Background: PubMed 10661673Carroll KM, Nich C, Sifry RL, Nuro KF, Frankforter TL, Ball SA, Fenton L, Rounsaville BJ. A general system for evaluating therapist adherence and competence in psychotherapy research in the addictions. Drug Alcohol Depend. 2000 Jan 1;57(3):225-38. doi: 10.1016/s0376-8716(99)00049-6.
BackgroundCarter, A. S., & Briggs-Gowan, M. J. (2000). The Infant-Toddler Social and Emotional Assessment (ITSEA). Unpublished Manual. University of Massachusetts Boston Department of Psychology, Boston, MA. Yale University, New Haven, CT. Available by request at alice.carter@umb.edu.
Background: PubMed 14561058Carter AS, Briggs-Gowan MJ, Jones SM, Little TD. The Infant-Toddler Social and Emotional Assessment (ITSEA): factor structure, reliability, and validity. J Abnorm Child Psychol. 2003 Oct;31(5):495-514. doi: 10.1023/a:1025449031360.
BackgroundCassidy, J., & Marvin, R. S., with MacArthur Attachment Working Group (1992). Attachment organization in preschool children: Procedures and coding manual (4th ed.). Unpublished manuscript, Department of Psychology, University of Virginia, Charlottesville, Virginia.
BackgroundConduct Problems Prevention Research Group (CPPRG). (1994). Financial Stress Questionnaire. Available from the Fast Track Project Web site: http://www.fasttrackproject.org
BackgroundCorrigan, J., & Schmidt, L. (1983). Development and validation of revisions in the Counselor Rating Form. Journal of Counseling Psychology, 30, 64-75. doi: 10.1037/0022-0167.30.1.64
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jude Cassidy, Ph.D. contact

301-405-4973

jcassidy@umd.edu

Susan Woodhouse, Ph.D. contact

610-758-3269

ssw212@lehigh.edu

Jude Cassidy, Ph.D. principal investigator

University of Maryland, College Park

Susan Woodhouse, Ph.D. principal investigator

Lehigh University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Circle of Security Parenting and Little Talks in people with Parent-Child Relations and Development, Infant, run by University of Maryland, College Park at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jude Cassidy, Ph.D. (301-405-4973, jcassidy@umd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Strange Situation Procedure (SSP) #1 (time frame: Baseline). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05834907, which also lists 41 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.