Opioid DependencemABCNCT04454645
Intervening With Opioid-Dependent MothersMothers and Infants
A study testing mABC and mDEF in people with Opioid Dependence and Parenting, run by University of Delaware at 1 site in United States.
Trial summary
This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence, Parenting, Infant Development
- What is being tested?
- mABC and mDEF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted treatment
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervening With Opioid-Dependent Mothers Living in Poverty: Effects on Mothers' and Infants' Behavioral and Biological Regulation
This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. The investigators expect that mothers who receive the modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. The investigators expect that infants whose mothers receive the modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment, behavior, and physiological regulation than infants of parents who receive the control intervention.
Read the detailed description
Pregnant mothers will be randomly assigned to receive the modified ABC intervention or the control intervention (modified DEF). Hypotheses relate to parent and child outcomes associated with the intervention. Hypothesis 1: Compared to mothers who receive the control intervention, mothers who receive the mABC intervention will show more nurturing and sensitive parenting, enhanced neural activity during parenting-relevant tasks, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production. Hypothesis 2: Compared to infants of mothers who receive the control intervention, infants of mothers who receive the mABC intervention will show more organized and secure attachment patterns, better behavioral regulation during stressors, more advanced social-emotional development, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production. Hypothesis 3: Enhanced maternal sensitivity will mediate effects of the mABC intervention on improved infant outcomes.
- Conditions
- Opioid Dependence, Parenting, Infant Development
- Being tested
- mABC, mDEF
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mABCBehavioural
Intervention targets parenting sensitivity and nurturance.
mDEFBehavioural
Intervention targets parenting enhancing infant cognitive development
| Study group | Role | What they receive |
|---|---|---|
| Modified ABC | Experimental | 12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior. Receives: Behavioral: mABC |
| Modified DEF | Active comparator | 12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development Receives: Behavioral: mDEF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal sensitivity
The mother will be assessed interacting with the infant simulator. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
Measured: Pre-intervention (3rd trimester)
Maternal sensitivity
The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
Measured: Infant age of 3 months
Maternal sensitivity
The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
Measured: Infant age of 6 months
Maternal sensitivity
The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
Measured: Infant age of 12 months
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Measured: Pre-intervention (3rd trimester)
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Measured: Infant age of 12 months
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Measured: Pre-intervention (3rd trimester)
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Measured: Infant age of 12 months
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Measured: Pre-intervention (3rd trimester)
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Measured: Infant age of 12 months
Maternal neural activity (Event related potentials - ERP) - Own child-other child task
Maternal event-related potentials (ERP) will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable.
Measured: Pre-intervention (3rd trimester)
Maternal neural activity (Event related potentials - ERP) - Own child-other child task
Maternal event-related potentials will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable.
Measured: Infant age of 12 months
Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable.
Measured: Pre-intervention (3rd trimester)
Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable.
Measured: Infant age of 12 months
Maternal neural activity (Event related potentials - ERP) - Child emotion task
Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable.
Measured: Pre-intervention (3rd trimester)
Maternal neural activity (Event related potentials - ERP) - Child emotion task
Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable.
Measured: Infant age of 12 months
Maternal parasympathetic nervous system activity during Still Face
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
Measured: Pre-intervention (3rd trimester)
Maternal parasympathetic nervous system activity
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
Measured: Infant age of 12 months
Infant parasympathetic nervous system activity
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
Measured: Infant age of 6 months
Infant parasympathetic nervous system activity
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
Measured: Infant age of 12 months
Infant diurnal cortisol production
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.
Measured: Infant age of 6 months
Infant diurnal cortisol production
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.
Measured: Infant age of 12 months
Infant behavioral regulation
Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9).
Measured: Infant age of 6 months
Infant behavioral regulation
Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9).
Measured: Infant age of 12 months
Infant attachment
Infant attachment will be assessed using the Strange Situation. Coding will be completed using the standard Strange Situation coding scheme (with 4 major categories, with secure preferable).
Measured: Infant age of 12 months
Infant cognitive development
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire. Scores could range from 0-300 with higher scores reflecting higher functioning.
Measured: Infant age of 12 months
Secondary outcomes (6)
Maternal substance use
Mothers will report on substance use through the Timeline Follow-Back Interview. Higher scores will reflect more use of illicit substances (score from 0-unlimited).
Measured: Pre-intervention (3rd trimester)
Maternal substance use
Mothers will report on substance use through the Timeline Follow-Back Interview. Higher scores will reflect more use of illicit substances (score from 0-unlimited).
Measured: Infant age of 12 months
Maternal depression
Mothers will report on their depression on the Beck Depression Inventory - II, with higher scores indicating more depressive symptoms reported. (Scores could range from 0-63.)
Measured: Pre-intervention (3rd trimester)
Maternal depression
Mothers will report on their depression on the Beck Depression Inventory - II, with higher scores indicating more depressive symptoms reported. (Scores could range from 0-63.)
Measured: Infant age of 12 months
Maternal executive functioning
Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning.
Measured: Pre-intervention (3rd trimester)
Maternal executive functioning
Mothers will complete Flanker task. Scores have a mean of 100 with a standard deviation of 15, with higher scores reflecting stronger executive functioning.
Measured: Infant age of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 May 2020
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Mary Dozier, University of Delaware
- Investigators
- Mary Dozier, Ph.D., Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454645
- Sponsor's protocol ID
- mABC
- Other IDs
- 1R01HD098525-01A1
- Acronym
- mABC
- Status last verified
- May 2026
- First submitted
- 9 Apr 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening With Opioid-Dependent Mothers Living in Poverty: Effects on Mothers' and Infants' Behavioral and Biological Regulation
- ClinicalTrials.gov ID
- NCT04454645
- Acronym / sponsor ID
- mABC / mABC
- Conditions
- Opioid Dependence, Parenting, Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 1 Jul 2020 (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.
This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. The investigators expect that mothers who receive the modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. The investigators expect that infants whose mothers receive the modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment, behavior, and physiological regulation than infants of parents who receive the control intervention.
Detailed description
Pregnant mothers will be randomly assigned to receive the modified ABC intervention or the control intervention (modified DEF). Hypotheses relate to parent and child outcomes associated with the intervention. Hypothesis 1: Compared to mothers who receive the control intervention, mothers who receive the mABC intervention will show more nurturing and sensitive parenting, enhanced neural activity during parenting-relevant tasks, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production. Hypothesis 2: Compared to infants of mothers who receive the control intervention, infants of mothers who receive the mABC intervention will show more organized and secure attachment patterns, better behavioral regulation during stressors, more advanced social-emotional development, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production. Hypothesis 3: Enhanced maternal sensitivity will mediate effects of the mABC intervention on improved infant outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified ABC | Experimental | Behavioral: mABC12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior. |
| Modified DEF | Active comparator | Behavioral: mDEF12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted treatment
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| mABCIntervention targets parenting sensitivity and nurturance. | Behavioural | Modified ABC |
| mDEFIntervention targets parenting enhancing infant cognitive development | Behavioural | Modified DEF |
Primary outcome
Maternal sensitivity
Time frame: Pre-intervention (3rd trimester)
The mother will be assessed interacting with the infant simulator. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
Maternal sensitivity
Time frame: Infant age of 3 months
The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
Maternal sensitivity
Time frame: Infant age of 6 months
The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
Maternal sensitivity
Time frame: Infant age of 12 months
The mother will be assessed interacting one-to-one with her infant. Parental sensitivity (a composite of following the child's lead in interactions, providing nurturance when the child is distressed, and showing positive regard) will be assessed using procedures and coding from the assessment used by the NICHD Study of Early Child Care and Youth Development (Brady-Smith et al., 1999). Sensitivity will be assessed on a 5-point scale with higher scores indicating greater sensitivity.
Maternal methylation of μ-opioid receptor (OPRM1) gene
Time frame: Pre-intervention (3rd trimester)
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Maternal methylation of μ-opioid receptor (OPRM1) gene
Time frame: Infant age of 12 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Maternal methylation of oxytocin receptor (OXTR) gene
Time frame: Pre-intervention (3rd trimester)
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Maternal methylation of oxytocin receptor (OXTR) gene
Time frame: Infant age of 12 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Infant methylation of μ-opioid receptor (OPRM1) gene
Time frame: Pre-intervention (3rd trimester)
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Infant methylation of μ-opioid receptor (OPRM1) gene
Time frame: Infant age of 12 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva
Maternal neural activity (Event related potentials - ERP) - Own child-other child task
Time frame: Pre-intervention (3rd trimester)
Maternal event-related potentials (ERP) will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable.
Maternal neural activity (Event related potentials - ERP) - Own child-other child task
Time frame: Infant age of 12 months
Maternal event-related potentials will be assessed while viewing photos of their own infants, familiar infants, and unfamiliar infants. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between own and other child considered preferable.
Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
Time frame: Pre-intervention (3rd trimester)
Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable.
Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
Time frame: Infant age of 12 months
Maternal event-related potentials will be assessed while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. The P300 (a positive deflection about 300 ms after the stimuli) will be studied, with a bigger difference between child and opioid-related images considered preferable.
Maternal neural activity (Event related potentials - ERP) - Child emotion task
Time frame: Pre-intervention (3rd trimester)
Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable.
Maternal neural activity (Event related potentials - ERP) - Child emotion task
Time frame: Infant age of 12 months
Maternal event-related potentials will be assessed while viewing images of children crying, laughing, and showing neutral expressions. The N180 (a negative deflection about 180 ms after the stimuli) will be studied, with a bigger difference between faces will be considered preferable.
Maternal parasympathetic nervous system activity during Still Face
Time frame: Pre-intervention (3rd trimester)
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
Maternal parasympathetic nervous system activity
Time frame: Infant age of 12 months
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
Infant parasympathetic nervous system activity
Time frame: Infant age of 6 months
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
Infant parasympathetic nervous system activity
Time frame: Infant age of 12 months
The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout a 15-minute period during the Still Face Procedure using a MindWare Portable Lab system. Greater changes in RSA from baseline to still face considered preferable.
Infant diurnal cortisol production
Time frame: Infant age of 6 months
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.
Infant diurnal cortisol production
Time frame: Infant age of 12 months
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at waketime and bed-time.
Infant behavioral regulation
Time frame: Infant age of 6 months
Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9).
Infant behavioral regulation
Time frame: Infant age of 12 months
Behavioral coding of emotion regulation will be conducted from video recordings of the Still Face Paradigm on the Behavioral Regulation Scale, a mild social stressor. Behavior regulation will be coded on a scale called Behavior Regulation. The scores will be continuous with higher scores indicating better regulation (ranging from 1-9).
Infant attachment
Time frame: Infant age of 12 months
Infant attachment will be assessed using the Strange Situation. Coding will be completed using the standard Strange Situation coding scheme (with 4 major categories, with secure preferable).
Infant cognitive development
Time frame: Infant age of 12 months
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire. Scores could range from 0-300 with higher scores reflecting higher functioning.
6 secondary outcomes
Maternal substance use
Time frame: Pre-intervention (3rd trimester)
Maternal substance use
Time frame: Infant age of 12 months
Maternal depression
Time frame: Pre-intervention (3rd trimester)
Maternal depression
Time frame: Infant age of 12 months
Maternal executive functioning
Time frame: Pre-intervention (3rd trimester)
Maternal executive functioning
Time frame: Infant age of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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. This study is not recruiting at the moment.
Mary Dozier, Ph.D. principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mABC and mDEF in people with Opioid Dependence and Parenting, run by University of Delaware at 1 site 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal sensitivity (time frame: Pre-intervention (3rd trimester)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.