Parental Interventions for Toddler Sleep and Behavior Support

(PATH Trial)

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

500 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial trains parents of low-income toddlers with sleep and behavior problems to manage these issues through coaching sessions. The goal is to improve the child's sleep and behavior, leading to better family functioning.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Family Check-Up (FCU) for toddler sleep and behavior support?

Research shows that the Family Check-Up (FCU) treatment has been effective in improving parenting skills and child behavioral health, such as self-regulation and reducing conduct and emotional problems. These improvements in parenting and child behavior suggest that FCU could also be beneficial for toddler sleep and behavior support. ^{1 2 3 4 5}

Is the Family Check-Up intervention safe for use in humans?

The Family Check-Up (FCU) intervention has been studied in various settings, including schools and primary care, and has shown positive effects on parenting and child behavioral health without any reported safety concerns. ^{1 2 3 4 5}

How is the Family Check-Up treatment unique for toddler sleep and behavior support?

The Family Check-Up (FCU) treatment is unique because it is a family-centered intervention that focuses on motivating positive changes in parenting and family dynamics, which can improve child behavior and sleep. Unlike other treatments that might focus solely on the child, FCU involves the whole family and adapts to their specific needs, making it a tailored approach. ^{1 3 5 6 7}

Research Team

Amanda R Tarullo, Ph.D.

Principal Investigator

Boston University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 (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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Examining family-school engagement in a randomized controlled trial of the family check-up. [2020]

2. United States 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). [2023]

3. England pubmed.ncbi.nlm.nih.gov

The Family Check-Up in early childhood: a case study of intervention process and change. [2019]

4. United States 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2021]

7. United States 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. [2020]