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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 age at enrollment of 18-48 months

Be younger than 18 years old

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 is between 18 and 48 months old.

PATH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from screening to five months post-intervention

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.

0 / 1Eligibility criteria met

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

Recent research and studies

JAMA PediatricsJournal

The Feedback Whirlpool of Early Childhood Sleep and Behavior Problems

Garrison, Michelle M.. 2015. “The Feedback Whirlpool of Early Childhood Sleep and Behavior Problems”. JAMA Pediatrics. American Medical Association (AMA). doi:10.1001/jamapediatrics.2015.0356.

Developmental PsychologyJournal

Emotion Regulation Among School-age Children: The Development and Validation of a New Criterion Q-sort Scale.

Shields, Ann, and Dante Cicchetti. 1997. “Emotion Regulation Among School-age Children: The Development and Validation of a New Criterion Q-sort Scale.”. Developmental Psychology. American Psychological Association (APA). doi:10.1037/0012-1649.33.6.906.

Behavioral Sleep MedicineJournal

Sleep Hygiene Practices and Bedtime Resistance in Low-income Preschoolers: Does Temperament Matter?

Wilson, Katherine E., Julie C. Lumeng, Niko Kaciroti, Sophie Yu-Pu Chen, Monique K. LeBourgeois, Ronald D. Chervin, and Alison L. Miller. 2014. “Sleep Hygiene Practices and Bedtime Resistance in Low-income Preschoolers: Does Temperament Matter?”. Behavioral Sleep Medicine. Informa UK Limited. doi:10.1080/15402002.2014.940104.

Annual Review of Public HealthJournal