Parental Interventions for Toddler Sleep and Behavior Support
(PATH Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston University Charles River Campus
Disqualifiers: Developmental disabilities, Autoimmune disorders, Cancer, others
No Placebo Group
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.
12345Is 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.
12345How 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.
13567Eligibility 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.
+2 more
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.
Trial 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)
Participant Groups
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.
4Treatment groups
Experimental Treatment
Active Control
Group I: Sleep HealthExperimental Treatment1 Intervention
Family receives the Sleep Health In Preschoolers parenting intervention to address toddler sleep problems.
Group II: ChoiceExperimental Treatment2 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 HealthExperimental Treatment1 Intervention
Family receives the Family Check-Up parenting intervention to address toddler behavior problems.
Group IV: ControlActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston UniversityBoston, MA
University of DenverDenver, CO
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Who Is Running the Clinical Trial?
Boston University Charles River CampusLead Sponsor
University of DenverCollaborator
Denver Health and Hospital AuthorityCollaborator
University of Colorado, BoulderCollaborator
University of MichiganCollaborator
References
Examining family-school engagement in a randomized controlled trial of the family check-up. [2020]The impact of the Family Check-Up (FCU) on family-school engagement was tested in a randomized, controlled trial. Participants were primary caregivers of 321 children. Approximately 87% of families randomly assigned to the intervention agreed to participate and received the intervention. Caregivers in the FCU condition outperformed caregivers in the school-as-usual condition on family-school engagement at home. In addition to outcomes, implementation of the FCU during kindergarten was examined, including family participation in the FCU, dosage, consumer satisfaction, and content of the follow-up sessions when delivered by FCU therapists. Total treatment time averaged at approximately 143 minutes and family therapists had an average of 4.05 contacts with families. The top three topics discussed during feedback and treatment visits were child behavior, positive parenting, and child academic skills. Children's baseline behavior and caregiver perception of the FCU significantly predicted participation in the FCU. Implications for family-centered interventions are discussed. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
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]Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
The Family Check-Up in early childhood: a case study of intervention process and change. [2019]This article describes a case study in the use of the Family Check-Up (FCU), a family-based and ecological preventive intervention for children at risk for problem behavior. The FCU is an assessment-driven intervention that utilizes a health maintenance model; emphasizes motivation for change; and offers an adaptive, tailored approach to intervention. This case study follows one Caucasian family through their initial assessment and subsequent treatment for their toddler daughter's conduct problems over a 2-year period. Clinically meaningful improvements in child and family functioning were found despite the presence of child, parent, and neighborhood risk factors. The case is discussed with respect to the findings from a current multisite randomized control trial of the FCU and its application to other populations.
Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in Primary Care. [2021]The Family Check-Up 4 Health (FCU4Health) is an adaptation of the Family Check-Up (FCU) for delivery in primary care settings. While maintaining the original FCU's focus on parenting and child behavioral health, we added content targeting health behaviors. This study evaluated whether the adapted FCU maintained positive effects on parenting (positive behavior support, limit setting, parental warmth) and child behavioral health (self-regulation, conduct problems, emotional problems). Pediatric (6-12 years) primary care patients with a BMI ≥ 85th%ile (n = 240) were recruited from primary care clinics in Phoenix. Children were 75% Latino, 49% female, and 73% Medicaid recipients. This type 2 effectiveness-implementation hybrid trial compared families randomized to FCU4Health (n = 141) or usual care (n = 99). FCU4Health was delivered over a period of 6 months. This study focuses on a priori secondary outcomes included parenting and child behavioral health targets of the original FCU, assessed at baseline and 3, 6, and 12 months. Significant improvements were found for the FCU4Health condition, compared to usual care, in parenting from baseline to the 3-month assessment [β = .17 (.01; .32)]. Parenting predicted improvements in child self-regulation at 6-months [β = .17 (.03; .30)], which in turn predicted reductions in conduct problems [β = - .38 (- .51; - .23)] and emotional problems [β = - .24 (- .38; - .09)] at 12 months. Ethnicity and language of delivery (English or Spanish) did not moderate these effects. The FCU4Health can improve parenting and child behavioral health outcomes when delivered in primary care.Trial Registration Trial registration number: NCT03013309 ClinicalTrials.gov.
A school-based, family-centered intervention to prevent substance use: the family check-up. [2021]The Family Check-Up (FCU) is a selected intervention model that can be delivered in contexts such as schools that serve at-risk children and families. It is grounded in developmental theory and targets salient risk factors for the development of later problem behavior such as substance use, family management deficits, deviant peer affiliations, and problem behavior at school.
Engaging parents in the family check-up in middle school: longitudinal effects on family conflict and problem behavior through the high school transition. [2021]Adolescence is a time of significant developmental change. During this period, levels of problem behavior that had been relatively innocuous may escalate in the company of peers, with simultaneous reductions in parental monitoring and involvement. In this article, we report the results of a randomized controlled trial of the Family Check-Up (FCU), a family-centered, school-based intervention designed to forestall the escalation of adolescent problem behavior by promoting and motivating skillful parenting through the transition to high school.
Effects of the Family Check-Up on reducing growth in conduct problems from toddlerhood through school age: An analysis of moderated mediation. [2020]The Family Check-Up (FCU) is a preventive intervention found to significantly reduce child conduct problems (CP). This study examined the extent to which parents reported that their child's CP were a problem for them at baseline (baseline CP) as a moderator of FCU effects into middle childhood and moderated mediation models to explore positive parent-child dyadic interaction and maternal depressive symptoms as mediators.