Sleep ProblemPATHNCT04824989
Parents Advancing Toddler Health
A study testing Sleep Health in Preschoolers (SHIP) and Family Check-Up (FCU) in people with Sleep Problem and Behavior, Child, run by Boston University Charles River Campus at 2 sites in United States.
Trial summary
Although early interventions can improve health equity in young children living in poverty, this promise often is not realized because of barriers to family engagement. The proposed study will target co-morbid behavior and sleep problems in early childhood, comparing child outcomes and family response to sleep and… Read more about this study
- Who is it for?
- Ages 18 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep Problem, Behavior, Child
- What is being tested?
- Sleep Health in Preschoolers (SHIP) and Family Check-Up (FCU)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2021to Feb 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 18 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child age at enrollment of 18-48 months;
- household income at or below 300% of the federal poverty line
- a parent fluent in English or Spanish
- child behavior problem as indicated by a score > 60 on the Emotionally Reactive, Anxious/Depressed, Withdrawn, Attention Problems, or Aggressive Behavior subscales of the Child Behavior Checklist 1 ½ - 5 years (CBCL 1 ½ - 5)
- child sleep problem as indicated by at least one of the following: score 1 standard deviation above community means on any subscale of the Children's Sleep Wake Scale or on the Sleep Anxiety subscale of the Children's Sleep Habits Questionnaire; nighttime sleep latency longer than 30 minutes; score >40 on the Children's Sleep Habits Questionnaire (CSHQ); bedtimes or wake times varying by more than 2 hours from day to day; and/or nighttime sleep duration ≤ 9.5 hr.
Who cannot join
- Diagnosed developmental disabilities
- Serious chronic medical conditions such as autoimmune disorders or cancer
- A positive screen on the Sleep Disordered Breathing or Parasomnia subscales of the CSHQ or parent-reported diagnosis of obstructive sleep apnea
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston University
Boston, Massachusetts, 02215
University of Denver
Denver, Colorado, 80208
About this study
Official title: Advancing Engagement and Efficacy of Interventions for Co-Morbid Sleep and Behavior Problems in Young Children
Although early interventions can improve health equity in young children living in poverty, this promise often is not realized because of barriers to family engagement. The proposed study will target co-morbid behavior and sleep problems in early childhood, comparing child outcomes and family response to sleep and behavior interventions and investigating the novel strategy of letting families select their intervention.We will enroll 500 low-income toddlers with co-morbid sleep and behavior problems, randomized to 4 parent coaching interventions: sleep, behavior, family choice (sleep or behavior), and an active control. At baseline and at 1, 5, and 9 months post- intervention, we will assess child sleep and behavior and family functioning. We will measure family preference, engagement, and perceived value of each intervention. The goals of the study are: (1) to examine effects of evidence- based sleep and behavior interventions in young low-income children with co-morbid sleep and behavior problems on child sleep and behavior and family functioning; (2) to determine whether parents prefer, engage with, and value a sleep or behavior intervention more; and (3) to examine if giving families a choice of intervention results in higher engagement, higher perceived value and better family and child outcomes than assignment to intervention. By informing best practices for engaging low-income families to treat co-morbid sleep and behavior problems, results will be critical to reducing health disparities for children living in poverty.
Read the detailed description
Children living in poverty have a high incidence of early-developing sleep and behavior problems, which are often co-morbid. Early sleep and behavior problems are prevalent and persistent risk factors for lifelong poor mental and physical health outcomes, and may be key mechanisms underlying early and enduring socioeconomic health disparities. While effective interventions exist, low-income families have low enrollment and retention in these interventions. Stigma of treating behavior problems creates an additional barrier to treatment. This RCT aims to address these barriers to treatment for low-income children with co-morbid sleep and behavior problems. Sleep and behavior problems and family dysfunction transact across time, increasing in severity, while healthy sleep, positive child behaviors, and effective parenting can support each other across development. Thus we posit that intervention in one domain, either sleep or behavior, may improve outcomes both within and across domains.
The proposed study is a parallel randomized controlled trial of behavioral treatments for sleep problems and behavior problems in early childhood. The current study will test our three key aims: that evidence based sleep and behavior interventions each will improve trajectories from early comorbid sleep and behavior problems to healthier outcomes (Aim 1); that family preference, engagement, and value may differ for sleep vs. behavior interventions (Aim 2); and that families who choose between sleep and behavior interventions will have a more positive family response and better outcomes than those assigned to an intervention (Aim 3). This study will enroll 500 low income children ages 24 to 48 months with comorbid sleep and behavior problems. Children will be recruited at Boston University and the University of Denver. Eligible participants will be randomized to one of four intervention arms, Behavior (FCU), Sleep (SHIP), Choice (FCU or SHIP, as selected by primary caregiver), and active Control (Oral Health, Child Safety, and Environmental Health). For those assigned to Choice, the primary caregiver will be provided information about FCU and SHIP and will select their preferred intervention.
At the baseline evaluation (T1) all participants will undergo the following procedures: a) An evaluation of child behavior b) an evaluation of child sleep c) an evaluation of family functioning. Following the baseline evaluation all participants will engage in 8 sessions of parent coaching intervention over a 2 month period, with the content of the intervention varying by intervention arm, see descriptions below. The SHIP and FCU have similar structure, emphasizing motivational interviewing and support for parent goals. Paraprofessional staff at each site will be trained to deliver the FCU, SHIP, and Control interventions.
The measures included in the T1 baseline evaluation will be repeated at 1 and 5 months post intervention, T2 and T3. At T4, 9 months post intervention, primary caregiver report of child behavior and sleep symptoms and family functioning will be collected via telephone interview.
- Conditions
- Sleep Problem, Behavior, Child
- Being tested
- Sleep Health in Preschoolers (SHIP), Family Check-Up (FCU), Oral Health, Child Safety, and Environmental Health Intervention (Active Control)
- Keywords
- sleep problems, behavior problems, parenting interventions, early childhood, poverty
- Medical subject headings
- Parasomnias, Child Behavior, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Health in Preschoolers (SHIP)Behavioural
SHIP is an 8 session home visiting intervention to reduce child sleep problems using a framework that draws from motivational interviewing and social cognitive theory, and effectively improves sleep timing, duration, and quality. Following ecological assessment of child sleep and sleep routines, feedback is provided on family strengths and challenges in the child sleep domain, with motivational interviewing to increase parent knowledge of sleep, correct misperceptions, and raise outcomes expectations. The remaining sessions are targeted modules that give tailored feedback and education, and coach the parent in setting manageable goals, identifying action steps, anticipating barriers, and supporting positive behaviors. Targets: bedtime scheduling, consistency, and routines; media use, independent sleep onset, nightmares and fears, night wakings, and early waking; sleep location, nap issues, engaging other caregivers.
Family Check-Up (FCU)Behavioural
FCU is an 8 session home visiting intervention to reduce behavior problems for children through improved parenting. Over 30 years of research establishes its efficacy in reducing behavioral and emotional problems, including in low income toddlers. Following ecological assessment of behavior management and child behavior, family receives feedback on family strengths and challenges within the behavioral domain via a motivational interviewing approach. The remaining sessions are targeted modules drawn from the Everyday Parenting curriculum, individualized based on parent goals and identified challenge areas. Each session begins by establishing a collaborative skill set, involves teaching the rationale for a skill, teaching and modeling effective use of the skill, and then role play and experiential practice to coach the parent to success. Targets can include Positive Behavior Support, Limit Setting and Monitoring, Family Routines, Communication, and Problem Solving.
Oral Health, Child Safety, and Environmental Health Intervention (Active Control)Behavioural
This intervention serves as an active control condition to ensure that observed effects are due to the intervention content, rather than to study processes, staff attention, or general support and problem solving. The intervention is designed to be comparable to SHIP and FCU in intensity, personal contact, session structure and approach, but focused on Oral Health, Child Safety, and Environmental Health, domains which should not immediately affect study outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Health | Experimental | Family receives the Sleep Health In Preschoolers parenting intervention to address toddler sleep problems. Receives: Behavioral: Sleep Health in Preschoolers (SHIP) |
| Behavior Health | Experimental | Family receives the Family Check-Up parenting intervention to address toddler behavior problems. Receives: Behavioral: Family Check-Up (FCU) |
| Choice | Experimental | Family is given the opportunity to select either the Sleep Health in Preschoolers intervention to address toddler sleep problems or the Family Check-Up intervention to address toddler behavior problems. Receives: Behavioral: Sleep Health in Preschoolers (SHIP); Behavioral: Family Check-Up (FCU) |
| Control | Active comparator | Family receives a safety and hygiene active control intervention. Receives: Behavioral: Oral Health, Child Safety, and Environmental Health Intervention (Active Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Behavior Checklist (CBCL) from screening to one month
This parent report for ages 1.5-5 assesses clinically significant behavior problems and yields age-normed subscales
Measured: Change from screening to one month post-intervention
Change in Child Behavior Checklist (CBCL) from screening to five months
This parent report for ages 1.5-5 assesses clinically significant behavior problems and yields age-normed subscales
Measured: Change from screening to five months post-intervention
Change in Child Behavior Checklist (CBCL) from screening to nine months
This parent report for ages 1.5-5 assesses clinically significant behavior problems and yields age-normed subscales
Measured: Change from screening to nine months post-intervention
Change in Emotion Regulation Checklist (ERC) from baseline to one month
Parent report assessing intensity, flexibility, and appropriateness of child emotions
Measured: Change from baseline to one month post-intervention
Change in Emotion Regulation Checklist (ERC) from baseline to five months
Parent report assessing intensity, flexibility, and appropriateness of child emotions
Measured: Change from baseline to five months post-intervention
Change in Emotion Regulation Checklist (ERC) from baseline to nine months
Parent report assessing intensity, flexibility, and appropriateness of child emotions
Measured: Change from baseline to nine months post-intervention
Change in Children's Sleep Wake Scale (CSWS) from screening to one month
Parent report assessing child bedtime resistance, sleep quality, and daytime sleepiness
Measured: Change from screening to one month post-intervention
Change in Children's Sleep Wake Scale (CSWS) from screening to five months
Parent report assessing child bedtime resistance, sleep quality, and daytime sleepiness
Measured: Change from screening to five months post-intervention
Change in Children's Sleep Wake Scale (CSWS) from screening to nine months
Parent report assessing child bedtime resistance, sleep quality, and daytime sleepiness
Measured: Change from screening to nine months post-intervention
Change in nighttime sleep minutes from baseline to one month as measured by actigraphy
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of nighttime sleep minutes. Data are analyzed using Actiware software.
Measured: Change from baseline to one month post-intervention
Change in nighttime sleep minutes from baseline to five months as measured by actigraphy
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of nighttime sleep minutes. Data are analyzed using Actiware software.
Measured: Change from baseline to five months post-intervention
Change in sleep onset from baseline to one month as measured by actigraphy
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep onset. Data are analyzed using Actiware software.
Measured: Change from baseline to one month post-intervention
Change in sleep onset from baseline to five months as measured by actigraphy
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep onset. Data are analyzed using Actiware software.
Measured: Change from baseline to five months post-intervention
Change in sleep consistency from baseline to one month as measured by actigraphy
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep consistency (consistency in sleep timing from night to night). Data are analyzed using Actiware software.
Measured: Change from baseline to one month post-intervention
Change in sleep consistency from baseline to five months as measured by actigraphy
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep consistency (consistency in sleep timing from night to night). Data are analyzed using Actiware software.
Measured: Change from baseline to five months post-intervention
Secondary outcomes (9)
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to one month
Parent report assessing sleep inhibiting and sleep facilitating behaviors
Measured: Change from baseline to one month post-intervention
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to five months
Parent report assessing sleep inhibiting and sleep facilitating behaviors
Measured: Change from baseline to five months post-intervention
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to nine months
Parent report assessing sleep inhibiting and sleep facilitating behaviors
Measured: Change from baseline to nine months post-intervention
Change in Parenting Sense of Competence (PSOC) from baseline to one month
Parent report assessing parental perceived efficacy, a dimension of family functioning
Measured: Change from baseline to one month post-intervention
Change in Parenting Sense of Competence (PSOC) from baseline to five months
Parent report assessing parental perceived efficacy, a dimension of family functioning
Measured: Change from baseline to five months post-intervention
Change in Parenting Sense of Competence (PSOC) from baseline to nine months
Parent report assessing parental perceived efficacy, a dimension of family functioning
Measured: Change from baseline to nine months post-intervention
Change in Peds QL Family Impact Module from baseline to one month
Parent report assessing family functioning
Measured: Change from baseline to one month post-intervention
Change in Peds QL Family Impact Module from baseline to five months
Parent report assessing family functioning
Measured: Change from baseline to five months post-intervention
Change in Peds QL Family Impact Module from baseline to nine months
Parent report assessing family functioning
Measured: Change from baseline to nine months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start22 Mar 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sleep ProblemStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Families are randomly assigned to one of four groups for an 8-week parent coaching intervention program: focus on (1) child sleep, (2) child behavior, (3) parent choice of child sleep or child behavior, (4) active control - safety \& hygiene
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Denver, University of Michigan, Denver Health and Hospital Authority, University of Colorado, Boulder, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Amanda R Tarullo, Ph.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824989
- Sponsor's protocol ID
- 5554E
- Other IDs
- 1R01HD098167-01A1
- Acronym
- PATH
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garrison MM. The feedback whirlpool of early childhood sleep and behavior problems. JAMA Pediatr. 2015 Jun;169(6):525-6. doi: 10.1001/jamapediatrics.2015.0356. No abstract available.
PubMed 25868054El-Sheikh M, Buckhalt JA, Mark Cummings E, Keller P. Sleep disruptions and emotional insecurity are pathways of risk for children. J Child Psychol Psychiatry. 2007 Jan;48(1):88-96. doi: 10.1111/j.1469-7610.2006.01604.x.
PubMed 17244274Campbell SB. Behavior problems in preschool children: a review of recent research. J Child Psychol Psychiatry. 1995 Jan;36(1):113-49. doi: 10.1111/j.1469-7610.1995.tb01657.x.
PubMed 7714027Jackson CL, Redline S, Emmons KM. Sleep as a potential fundamental contributor to disparities in cardiovascular health. Annu Rev Public Health. 2015 Mar 18;36:417-40. doi: 10.1146/annurev-publhealth-031914-122838.
PubMed 25785893LeBourgeois MK, Harsh JR. Development and psychometric evaluation of the Children's Sleep-Wake Scale<sup/> Sleep Health. 2016 Sep;2(3):198-204. doi: 10.1016/j.sleh.2016.04.001.
PubMed 28066802Shields A, Cicchetti D. Emotion regulation among school-age children: the development and validation of a new criterion Q-sort scale. Dev Psychol. 1997 Nov;33(6):906-16. doi: 10.1037//0012-1649.33.6.906.
PubMed 9383613Wilson KE, Lumeng JC, Kaciroti N, Chen SY, LeBourgeois MK, Chervin RD, Miller AL. Sleep Hygiene Practices and Bedtime Resistance in Low-Income Preschoolers: Does Temperament Matter? Behav Sleep Med. 2015;13(5):412-23. doi: 10.1080/15402002.2014.940104. Epub 2014 Sep 15.
PubMed 25221914Sivertsen B, Harvey AG, Reichborn-Kjennerud T, Torgersen L, Ystrom E, Hysing M. Later emotional and behavioral problems associated with sleep problems in toddlers: a longitudinal study. JAMA Pediatr. 2015 Jun;169(6):575-82. doi: 10.1001/jamapediatrics.2015.0187.
PubMed 25867179Shaw DS, Shelleby EC. Early-starting conduct problems: intersection of conduct problems and poverty. Annu Rev Clin Psychol. 2014;10:503-28. doi: 10.1146/annurev-clinpsy-032813-153650.
PubMed 24471370Mulraney M, Giallo R, Lycett K, Mensah F, Sciberras E. The bidirectional relationship between sleep problems and internalizing and externalizing problems in children with ADHD: a prospective cohort study. Sleep Med. 2016 Jan;17:45-51. doi: 10.1016/j.sleep.2015.09.019. Epub 2015 Oct 23.
PubMed 26847973
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Engagement and Efficacy of Interventions for Co-Morbid Sleep and Behavior Problems in Young Children
- ClinicalTrials.gov ID
- NCT04824989
- Acronym / sponsor ID
- PATH / 5554E
- Conditions
- Sleep Problem, Behavior, Child
- Keywords
- sleep problems, behavior problems, parenting interventions, early childhood, poverty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- University of Denver, University of Michigan, Denver Health and Hospital Authority, University of Colorado, Boulder, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 1 Apr 2021 (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.
Although early interventions can improve health equity in young children living in poverty, this promise often is not realized because of barriers to family engagement. The proposed study will target co-morbid behavior and sleep problems in early childhood, comparing child outcomes and family response to sleep and behavior interventions and investigating the novel strategy of letting families select their intervention.We will enroll 500 low-income toddlers with co-morbid sleep and behavior problems, randomized to 4 parent coaching interventions: sleep, behavior, family choice (sleep or behavior), and an active control. At baseline and at 1, 5, and 9 months post- intervention, we will assess child sleep and behavior and family functioning. We will measure family preference, engagement, and perceived value of each intervention. The goals of the study are: (1) to examine effects of evidence- based sleep and behavior interventions in young low-income children with co-morbid sleep and behavior problems on child sleep and behavior and family functioning; (2) to determine whether parents prefer, engage with, and value a sleep or behavior intervention more; and (3) to examine if giving families a choice of intervention results in higher engagement, higher perceived value and better family and child outcomes than assignment to intervention. By informing best practices for engaging low-income families to treat co-morbid sleep and behavior problems, results will be critical to reducing health disparities for children living in poverty.
Detailed description
Children living in poverty have a high incidence of early-developing sleep and behavior problems, which are often co-morbid. Early sleep and behavior problems are prevalent and persistent risk factors for lifelong poor mental and physical health outcomes, and may be key mechanisms underlying early and enduring socioeconomic health disparities. While effective interventions exist, low-income families have low enrollment and retention in these interventions. Stigma of treating behavior problems creates an additional barrier to treatment. This RCT aims to address these barriers to treatment for low-income children with co-morbid sleep and behavior problems. Sleep and behavior problems and family dysfunction transact across time, increasing in severity, while healthy sleep, positive child behaviors, and effective parenting can support each other across development. Thus we posit that intervention in one domain, either sleep or behavior, may improve outcomes both within and across domains.
The proposed study is a parallel randomized controlled trial of behavioral treatments for sleep problems and behavior problems in early childhood. The current study will test our three key aims: that evidence based sleep and behavior interventions each will improve trajectories from early comorbid sleep and behavior problems to healthier outcomes (Aim 1); that family preference, engagement, and value may differ for sleep vs. behavior interventions (Aim 2); and that families who choose between sleep and behavior interventions will have a more positive family response and better outcomes than those assigned to an intervention (Aim 3). This study will enroll 500 low income children ages 24 to 48 months with comorbid sleep and behavior problems. Children will be recruited at Boston University and the University of Denver. Eligible participants will be randomized to one of four intervention arms, Behavior (FCU), Sleep (SHIP), Choice (FCU or SHIP, as selected by primary caregiver), and active Control (Oral Health, Child Safety, and Environmental Health). For those assigned to Choice, the primary caregiver will be provided information about FCU and SHIP and will select their preferred intervention.
At the baseline evaluation (T1) all participants will undergo the following procedures: a) An evaluation of child behavior b) an evaluation of child sleep c) an evaluation of family functioning. Following the baseline evaluation all participants will engage in 8 sessions of parent coaching intervention over a 2 month period, with the content of the intervention varying by intervention arm, see descriptions below. The SHIP and FCU have similar structure, emphasizing motivational interviewing and support for parent goals. Paraprofessional staff at each site will be trained to deliver the FCU, SHIP, and Control interventions.
The measures included in the T1 baseline evaluation will be repeated at 1 and 5 months post intervention, T2 and T3. At T4, 9 months post intervention, primary caregiver report of child behavior and sleep symptoms and family functioning will be collected via telephone interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Families are randomly assigned to one of four groups for an 8-week parent coaching intervention program: focus on (1) child sleep, (2) child behavior, (3) parent choice of child sleep or child behavior, (4) active control - safety \& hygiene
| Arm | Type | Receives |
|---|---|---|
| Sleep Health | Experimental | Behavioral: Sleep Health in Preschoolers (SHIP)Family receives the Sleep Health In Preschoolers parenting intervention to address toddler sleep problems. |
| Behavior Health | Experimental | Behavioral: Family Check-Up (FCU)Family receives the Family Check-Up parenting intervention to address toddler behavior problems. |
| Choice | Experimental | Behavioral: Sleep Health in Preschoolers (SHIP), Behavioral: Family Check-Up (FCU)Family is given the opportunity to select either the Sleep Health in Preschoolers intervention to address toddler sleep problems or the Family Check-Up intervention to address toddler behavior problems. |
| Control | Active comparator | Behavioral: Oral Health, Child Safety, and Environmental Health Intervention (Active Control)Family receives a safety and hygiene active control intervention. |
Who may qualify
- Ages
- 18 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- child age at enrollment of 18-48 months;
- household income at or below 300% of the federal poverty line
- a parent fluent in English or Spanish
- child behavior problem as indicated by a score > 60 on the Emotionally Reactive, Anxious/Depressed, Withdrawn, Attention Problems, or Aggressive Behavior subscales of the Child Behavior Checklist 1 ½ - 5 years (CBCL 1 ½ - 5)
- child sleep problem as indicated by at least one of the following: score 1 standard deviation above community means on any subscale of the Children's Sleep Wake Scale or on the Sleep Anxiety subscale of the Children's Sleep Habits Questionnaire; nighttime sleep latency longer than 30 minutes; score >40 on the Children's Sleep Habits Questionnaire (CSHQ); bedtimes or wake times varying by more than 2 hours from day to day; and/or nighttime sleep duration ≤ 9.5 hr.
Key exclusion criteria (3 listed)
- Diagnosed developmental disabilities
- Serious chronic medical conditions such as autoimmune disorders or cancer
- A positive screen on the Sleep Disordered Breathing or Parasomnia subscales of the CSHQ or parent-reported diagnosis of obstructive sleep apnea
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 |
|---|---|---|
| Sleep Health in Preschoolers (SHIP)SHIP is an 8 session home visiting intervention to reduce child sleep problems using a framework that draws from motivational interviewing and social cognitive theory, and effectively improves sleep timing, duration, and quality. Following ecological assessment of child sleep and sleep routines, feedback is provided on family strengths and challenges in the child sleep domain, with motivational interviewing to increase parent knowledge of sleep, correct misperceptions, and raise outcomes expectations. The remaining sessions are targeted modules that give tailored feedback and education, and coach the parent in setting manageable goals, identifying action steps, anticipating barriers, and supporting positive behaviors. Targets: bedtime scheduling, consistency, and routines; media use, independent sleep onset, nightmares and fears, night wakings, and early waking; sleep location, nap issues, engaging other caregivers. | Behavioural | Choice, Sleep Health |
| Family Check-Up (FCU)FCU is an 8 session home visiting intervention to reduce behavior problems for children through improved parenting. Over 30 years of research establishes its efficacy in reducing behavioral and emotional problems, including in low income toddlers. Following ecological assessment of behavior management and child behavior, family receives feedback on family strengths and challenges within the behavioral domain via a motivational interviewing approach. The remaining sessions are targeted modules drawn from the Everyday Parenting curriculum, individualized based on parent goals and identified challenge areas. Each session begins by establishing a collaborative skill set, involves teaching the rationale for a skill, teaching and modeling effective use of the skill, and then role play and experiential practice to coach the parent to success. Targets can include Positive Behavior Support, Limit Setting and Monitoring, Family Routines, Communication, and Problem Solving. | Behavioural | Behavior Health, Choice |
| Oral Health, Child Safety, and Environmental Health Intervention (Active Control)This intervention serves as an active control condition to ensure that observed effects are due to the intervention content, rather than to study processes, staff attention, or general support and problem solving. The intervention is designed to be comparable to SHIP and FCU in intensity, personal contact, session structure and approach, but focused on Oral Health, Child Safety, and Environmental Health, domains which should not immediately affect study outcomes. | Behavioural | Control |
Primary outcome
Change in Child Behavior Checklist (CBCL) from screening to one month
Time frame: Change from screening to one month post-intervention
This parent report for ages 1.5-5 assesses clinically significant behavior problems and yields age-normed subscales
Change in Child Behavior Checklist (CBCL) from screening to five months
Time frame: Change from screening to five months post-intervention
This parent report for ages 1.5-5 assesses clinically significant behavior problems and yields age-normed subscales
Change in Child Behavior Checklist (CBCL) from screening to nine months
Time frame: Change from screening to nine months post-intervention
This parent report for ages 1.5-5 assesses clinically significant behavior problems and yields age-normed subscales
Change in Emotion Regulation Checklist (ERC) from baseline to one month
Time frame: Change from baseline to one month post-intervention
Parent report assessing intensity, flexibility, and appropriateness of child emotions
Change in Emotion Regulation Checklist (ERC) from baseline to five months
Time frame: Change from baseline to five months post-intervention
Parent report assessing intensity, flexibility, and appropriateness of child emotions
Change in Emotion Regulation Checklist (ERC) from baseline to nine months
Time frame: Change from baseline to nine months post-intervention
Parent report assessing intensity, flexibility, and appropriateness of child emotions
Change in Children's Sleep Wake Scale (CSWS) from screening to one month
Time frame: Change from screening to one month post-intervention
Parent report assessing child bedtime resistance, sleep quality, and daytime sleepiness
Change in Children's Sleep Wake Scale (CSWS) from screening to five months
Time frame: Change from screening to five months post-intervention
Parent report assessing child bedtime resistance, sleep quality, and daytime sleepiness
Change in Children's Sleep Wake Scale (CSWS) from screening to nine months
Time frame: Change from screening to nine months post-intervention
Parent report assessing child bedtime resistance, sleep quality, and daytime sleepiness
Change in nighttime sleep minutes from baseline to one month as measured by actigraphy
Time frame: Change from baseline to one month post-intervention
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of nighttime sleep minutes. Data are analyzed using Actiware software.
Change in nighttime sleep minutes from baseline to five months as measured by actigraphy
Time frame: Change from baseline to five months post-intervention
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of nighttime sleep minutes. Data are analyzed using Actiware software.
Change in sleep onset from baseline to one month as measured by actigraphy
Time frame: Change from baseline to one month post-intervention
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep onset. Data are analyzed using Actiware software.
Change in sleep onset from baseline to five months as measured by actigraphy
Time frame: Change from baseline to five months post-intervention
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep onset. Data are analyzed using Actiware software.
Change in sleep consistency from baseline to one month as measured by actigraphy
Time frame: Change from baseline to one month post-intervention
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep consistency (consistency in sleep timing from night to night). Data are analyzed using Actiware software.
Change in sleep consistency from baseline to five months as measured by actigraphy
Time frame: Change from baseline to five months post-intervention
The Actiwatch Spectrum Plus actigraph will be worn on the child's non-dominant wrist for one week at each assessment to provide continuous recording of state via motion detection, and will yield an index of sleep consistency (consistency in sleep timing from night to night). Data are analyzed using Actiware software.
9 secondary outcomes
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to one month
Time frame: Change from baseline to one month post-intervention
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to five months
Time frame: Change from baseline to five months post-intervention
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to nine months
Time frame: Change from baseline to nine months post-intervention
Change in Parenting Sense of Competence (PSOC) from baseline to one month
Time frame: Change from baseline to one month post-intervention
Change in Parenting Sense of Competence (PSOC) from baseline to five months
Time frame: Change from baseline to five months post-intervention
Change in Parenting Sense of Competence (PSOC) from baseline to nine months
Time frame: Change from baseline to nine months post-intervention
Change in Peds QL Family Impact Module from baseline to one month
Time frame: Change from baseline to one month post-intervention
Change in Peds QL Family Impact Module from baseline to five months
Time frame: Change from baseline to five months post-intervention
Change in Peds QL Family Impact Module from baseline to nine months
Time frame: Change from baseline to nine months post-intervention
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 19 Aug 2026.
- Background: PubMed 25868054Garrison MM. The feedback whirlpool of early childhood sleep and behavior problems. JAMA Pediatr. 2015 Jun;169(6):525-6. doi: 10.1001/jamapediatrics.2015.0356. No abstract available.
- Background: PubMed 17244274El-Sheikh M, Buckhalt JA, Mark Cummings E, Keller P. Sleep disruptions and emotional insecurity are pathways of risk for children. J Child Psychol Psychiatry. 2007 Jan;48(1):88-96. doi: 10.1111/j.1469-7610.2006.01604.x.
- Background: PubMed 7714027Campbell SB. Behavior problems in preschool children: a review of recent research. J Child Psychol Psychiatry. 1995 Jan;36(1):113-49. doi: 10.1111/j.1469-7610.1995.tb01657.x.
- Background: PubMed 25785893Jackson CL, Redline S, Emmons KM. Sleep as a potential fundamental contributor to disparities in cardiovascular health. Annu Rev Public Health. 2015 Mar 18;36:417-40. doi: 10.1146/annurev-publhealth-031914-122838.
- Background: PubMed 28066802LeBourgeois MK, Harsh JR. Development and psychometric evaluation of the Children's Sleep-Wake Scale<sup/> Sleep Health. 2016 Sep;2(3):198-204. doi: 10.1016/j.sleh.2016.04.001.
- Background: PubMed 9383613Shields A, Cicchetti D. Emotion regulation among school-age children: the development and validation of a new criterion Q-sort scale. Dev Psychol. 1997 Nov;33(6):906-16. doi: 10.1037//0012-1649.33.6.906.
- Background: PubMed 25221914Wilson KE, Lumeng JC, Kaciroti N, Chen SY, LeBourgeois MK, Chervin RD, Miller AL. Sleep Hygiene Practices and Bedtime Resistance in Low-Income Preschoolers: Does Temperament Matter? Behav Sleep Med. 2015;13(5):412-23. doi: 10.1080/15402002.2014.940104. Epub 2014 Sep 15.
- Background: PubMed 25867179Sivertsen B, Harvey AG, Reichborn-Kjennerud T, Torgersen L, Ystrom E, Hysing M. Later emotional and behavioral problems associated with sleep problems in toddlers: a longitudinal study. JAMA Pediatr. 2015 Jun;169(6):575-82. doi: 10.1001/jamapediatrics.2015.0187.
- Background: PubMed 24471370Shaw DS, Shelleby EC. Early-starting conduct problems: intersection of conduct problems and poverty. Annu Rev Clin Psychol. 2014;10:503-28. doi: 10.1146/annurev-clinpsy-032813-153650.
- Background: PubMed 26847973Mulraney M, Giallo R, Lycett K, Mensah F, Sciberras E. The bidirectional relationship between sleep problems and internalizing and externalizing problems in children with ADHD: a prospective cohort study. Sleep Med. 2016 Jan;17:45-51. doi: 10.1016/j.sleep.2015.09.019. Epub 2015 Oct 23.
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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.
Amanda R Tarullo, Ph.D. principal investigator
Boston 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 Sleep Health in Preschoolers (SHIP) and Family Check-Up (FCU) in people with Sleep Problem and Behavior, Child, run by Boston University Charles River Campus 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. 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?
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?
Change in Child Behavior Checklist (CBCL) from screening to one month (time frame: Change from screening to one month post-intervention). The study lists 15 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 NCT04824989, which also lists 10 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 19 Aug 2026.