Parental Interventions for Toddler Sleep and Behavior Support

(PATH Trial)

Not currently recruiting at 1 trial location

Overseen By Amanda R Tarullo, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Developmental disabilities, Autoimmune disorders, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to assist low-income families with toddlers experiencing sleep and behavior issues. It compares four approaches: specific sleep interventions, specific behavior interventions, allowing parents to choose between these, and a general safety and hygiene program. The goal is to determine which method most effectively improves child sleep and behavior, as well as family functioning. Families with toddlers aged 18-48 months who have noticeable sleep and behavior problems and live at or below 300% of the federal poverty line may be suitable for this study. As an unphased study, this trial provides families the opportunity to contribute to important research that could enhance support for children facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both treatments in this trial have undergone thorough study and are considered safe.

For the Sleep Health in Preschoolers (SHIP) program, studies have found that it greatly improves sleep in young children. Importantly, no serious side effects have been reported, indicating it is well-tolerated by young children and poses no major risks.

The Family Check-Up (FCU) program also maintains a strong safety record. This proven program enhances parenting skills and improves child behavior. Research from past studies shows that it effectively helps families without causing harm or significant side effects.

Both programs have been used successfully, indicating they are safe options for addressing sleep and behavior issues in toddlers. Participants can feel confident that earlier research has carefully evaluated these programs for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they offer tailored approaches to common toddler issues like sleep and behavior, which are often addressed separately in standard treatments. The Sleep Health in Preschoolers (SHIP) intervention focuses specifically on improving sleep patterns in toddlers, potentially leading to better overall health and development. Meanwhile, the Family Check-Up (FCU) intervention targets behavior problems by offering personalized parenting strategies, which could be more effective than generic advice. Additionally, the unique "Choice" arm empowers families to select the intervention that best fits their needs, promoting a more customized and engaging approach. This flexibility and focus on specific areas are what set these interventions apart from typical, one-size-fits-all solutions.

What evidence suggests that this trial's interventions could be effective for improving toddler sleep and behavior?

Research shows that the Sleep Health in Preschoolers (SHIP) program, one of the interventions in this trial, helps young children sleep better. Improvements often appear within three months and may continue over time. Many children experience sleep issues, such as difficulty falling asleep or waking during the night, and SHIP effectively addresses these problems.

Studies also indicate that the Family Check-Up (FCU) program, another intervention in this trial, reduces behavior issues in children. It strengthens family relationships and improves overall family mental health. Parents often feel more confident in their parenting after participating in FCU, and children tend to exhibit fewer behavior problems. This trial will compare these programs, with some families receiving the SHIP intervention, others the FCU intervention, and a control group receiving a safety and hygiene intervention. Both programs aim to address sleep and behavior challenges, providing valuable support for families in need. ^{3 6 7 8 9}

Who Is on the Research Team?

Amanda R Tarullo, Ph.D.

Principal Investigator

Boston University

Are You a Good Fit for This Trial?

This trial is for low-income toddlers aged 18-48 months with both sleep and behavior problems. The child must have a specific score on the Child Behavior Checklist, indicating issues like being overly emotional or aggressive. Parents need to speak English or Spanish fluently, and household income should be at or below 300% of the federal poverty line.

Inclusion Criteria

A child shows significant behavior problems based on a specific questionnaire called the Child Behavior Checklist 1 ½ - 5 years (CBCL 1 ½ - 5).

My child has sleep issues based on specific sleep questionnaires or patterns.

My child is between 18 and 48 months old.

Exclusion Criteria

You have been diagnosed with developmental disabilities.

You have a positive result for sleep problems or a parent-reported diagnosis of obstructive sleep apnea.

I have a serious chronic condition like an autoimmune disorder or cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Baseline evaluation of child behavior, sleep, and family functioning

1 week

1 visit (in-person)

Treatment

Participants engage in 8 sessions of parent coaching intervention over a 2 month period

8 weeks

8 sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in sleep and behavior at 1, 5, and 9 months post-intervention

9 months

3 follow-up assessments (1 in-person, 2 via telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Family Check-Up (FCU)
• Oral Health, Child Safety, and Environmental Health Intervention (Active Control)
• Sleep Health in Preschoolers (SHIP)

Trial Overview

The study compares four parent coaching interventions: one focused on sleep, another on behavior, a third where families choose between sleep or behavior intervention, and an active control group focusing on oral health and safety. It aims to see which approach works best for improving children's sleep/behavior and family functioning.

How Is the Trial Designed?

Group I: Sleep Health Experimental Treatment 1 Intervention

Family receives the Sleep Health In Preschoolers parenting intervention to address toddler sleep problems.

Group II: Choice Experimental Treatment 2 Interventions

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.

Group III: Behavior Health Experimental Treatment 1 Intervention

Family receives the Family Check-Up parenting intervention to address toddler behavior problems.

Group IV: Control Active Control 1 Intervention

Family receives a safety and hygiene active control intervention.

Family Check-Up (FCU) is already approved in United States for the following indications:

Approved in United States as Family Check-Up for:

• Behavioral problems in children
• Sleep problems in children
• Family functioning issues

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

University of Denver

Collaborator

Trials

25

Recruited

10,600+

Denver Health and Hospital Authority

Collaborator

Trials

106

Recruited

403,000+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

The Family Check-Up (FCU) intervention demonstrated clinically meaningful improvements in both child behavior and family functioning over a 2-year period, even in the presence of various risk factors.

This case study supports findings from a larger multisite randomized control trial, suggesting that the FCU can be effectively applied to diverse populations at risk for problem behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Family Check-Up in early childhood: a case study of intervention process and change. Gill, AM., Hyde, LW., Shaw, DS., et al.[2019]

The Family Check-Up (FCU) intervention significantly reduces conduct problems in children, especially for those whose parents reported high levels of conduct problems at the start of the study, involving 731 mother-child dyads followed from ages 2 to 9.5.

The FCU not only decreased conduct problems but also improved positive interactions between parents and children, demonstrating its effectiveness in enhancing family dynamics regardless of the initial level of conduct problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Family Check-Up on reducing growth in conduct problems from toddlerhood through school age: An analysis of moderated mediation. Shelleby, EC., Shaw, DS., Dishion, TJ., et al.[2020]

The Family Check-Up (FCU) intervention significantly improved family-school engagement among caregivers of 321 children, with 87% of families participating in the program.

The intervention involved an average of 143 minutes of treatment time and focused on key topics like child behavior and positive parenting, indicating its practical application in enhancing family involvement in children's education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining family-school engagement in a randomized controlled trial of the family check-up. Garbacz, SA., Stormshak, EA., McIntyre, LL., et al.[2020]

The Family Check-Up 4 Health (FCU4Health) program is being tested for its effectiveness in improving child health behaviors and parenting practices in a low-income, majority Latino community, with 130 families receiving the intervention and 70 receiving usual services over three years.

This trial aims to demonstrate that integrated primary care settings can effectively deliver preventive interventions that address both behavioral and physical health, potentially increasing access for populations facing health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study). Berkel, C., Smith, JD., Bruening, MM., et al.[2023]

The Family Check-Up (FCU) intervention model has been shown to effectively enhance family management skills and reduce risk behaviors in at-risk children and families over 20 years of research.

Implementing the FCU in schools has been linked to a significant reduction in the long-term risk of substance use during adolescence, highlighting its potential as a valuable public health strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based, family-centered intervention to prevent substance use: the family check-up. Stormshak, EA., Dishion, TJ.[2021]

The Family Check-Up (FCU) intervention, involving 593 ethnically diverse families, effectively reduced the escalation of adolescent problem behaviors, including family conflict, antisocial behavior, and alcohol use, during the transition to high school.

Youth whose parents participated in the FCU showed significantly lower rates of these problem behaviors compared to a matched control group, highlighting the importance of engaging families in interventions to support adolescent development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging parents in the family check-up in middle school: longitudinal effects on family conflict and problem behavior through the high school transition. Van Ryzin, MJ., Stormshak, EA., Dishion, TJ.[2021]

The Family Check-Up 4 Health (FCU4Health) program, tested on 240 pediatric patients with elevated BMI, showed significant improvements in parenting skills and child behavioral health within 6 months compared to usual care.

Improvements in parenting were linked to better child self-regulation, which subsequently led to reductions in conduct and emotional problems, indicating a positive chain reaction from the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in Primary Care. Berkel, C., Fu, E., Carroll, AJ., et al.[2021]

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