Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
500 participants
INTERVENTIONAL
2021-03-22
2025-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Navigation and Parent Peer Support to Promote Access
NCT04029220
Collaboration to Promote Early Childhood Well Being in Families Experiencing Homelessness
NCT03530137
The Healthy Child Development Program Study
NCT04622969
Health Promotion in Early Adolescence: Sleep, Activity, and Emotion Regulation
NCT01289197
Behaviours and Emotions in Preschoolers
NCT03856931
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sleep Health
Family receives the Sleep Health In Preschoolers parenting intervention to address toddler sleep problems.
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.
Behavior Health
Family receives the Family Check-Up parenting intervention to address toddler behavior problems.
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.
Choice
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.
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.
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.
Control
Family receives a safety and hygiene active control intervention.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Months
48 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Denver
OTHER
University of Michigan
OTHER
Denver Health and Hospital Authority
OTHER
University of Colorado, Boulder
OTHER
Boston University Charles River Campus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amanda R Tarullo, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Denver
Denver, Colorado, United States
Boston University
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
El-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.
Campbell 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.
Jackson 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.
LeBourgeois 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.
Shields 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.
Wilson 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.
Sivertsen 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.
Shaw 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.
Mulraney 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5554E
Identifier Type: OTHER
Identifier Source: secondary_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.