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Parental Interventions for Toddler Sleep and Behavior Support (PATH Trial)

N/A
Recruiting
Led By Amanda R Tarullo, Ph.D.
Research Sponsored by Boston University Charles River Campus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Child age at enrollment of 18-48 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to five months post-intervention
Awards & highlights

PATH Trial Summary

This trial will test different ways of helping low-income parents support their toddlers' sleep and behavior, with the goal of reducing health disparities.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, there are no direct physical side effects expected from the treatments themselves. However, changes in routine could temporarily affect the child's mood or stress levels.

PATH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child has sleep issues based on specific sleep questionnaires or patterns.
Select...
My child is between 18 and 48 months old.
Select...
I am a parent who speaks English or Spanish fluently.

PATH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from screening to five months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from screening to five months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Child Behavior Checklist (CBCL) from screening to five months
Change in Child Behavior Checklist (CBCL) from screening to nine months
Change in Child Behavior Checklist (CBCL) from screening to one month
+12 more
Secondary outcome measures
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to five months
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to nine months
Change in Children's Sleep Hygiene Scale (CSHS) from baseline to one month
+6 more

PATH Trial Design

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.

Find a Location

Who is running the clinical trial?

University of DenverOTHER
23 Previous Clinical Trials
9,741 Total Patients Enrolled
Denver Health and Hospital AuthorityOTHER
101 Previous Clinical Trials
399,897 Total Patients Enrolled
University of Colorado, BoulderOTHER
119 Previous Clinical Trials
28,694 Total Patients Enrolled

Media Library

Family Check-Up (FCU) Clinical Trial Eligibility Overview. Trial Name: NCT04824989 — N/A
Sleep Disorders Research Study Groups: Sleep Health, Behavior Health, Choice, Control
Sleep Disorders Clinical Trial 2023: Family Check-Up (FCU) Highlights & Side Effects. Trial Name: NCT04824989 — N/A
Family Check-Up (FCU) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04824989 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accommodate applicants who have surpassed their 55th birthday?

"To be eligible, applicants must between 18 months and 48 months of age. Separate trials are available for those under 18 (70) or over 65 (128)."

Answered by AI

What is the scope of participation for this medical research?

"Affirmative. The information from clinicaltrials.gov shows that this scientific endeavour, which was launched on March 22nd 2021 is currently recruiting patients. Approximately 500 volunteers must be sourced across 2 healthcare establishments."

Answered by AI

Is the trial currently enrolling participants?

"According to the clinicaltrials.gov database, this medical experiment is open for enrollment. It was originally made available on March 22nd 2021 and its details were most recently updated on April 1st 2022."

Answered by AI

For which patient demographics is this clinical trial most suitable?

"This clinical trial is on the hunt for 500 infants and toddlers aged between 18 months and 48 months who suffer from dyssomnias. In addition, they must meet further requirements such as a household income within 300% of the federal poverty line, fluency in English or Spanish by at least one parent, scoring higher than average on any subscale of the Child Behavior Checklist 1 ½ - 5 years (CBCL) & Children's Sleep Wake Scale, having nighttime sleep latency beyond 30 minutes with scores exceeding 40 on the CSHQ; fluctuating bedtimes/waketimes varying more than 2 hours daily and sleeping ≤ 9.5"

Answered by AI

What is the projected outcome of this medical research?

"This clinical study will be tracking changes to the Emotion Regulation Checklist (ERC) between baseline and nine months post-intervention. Additionally, researchers will also evaluate alterations in the Peds QL Family Impact Module from baseline to one month which is a parental survey of family functioning, as well as variations in Children's Sleep Hygiene Scale (CSHS) from baseline to five months and again at one month; this second measure being another parent reported assessment that evaluates sleep inhibiting and facilitating behaviors."

Answered by AI
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~122 spots leftby Apr 2025