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Good Nights Sleep Program to Improve Child and Family Sleep

NCT06249217 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-23

No results posted yet for this study

Summary

The purpose of this study is to pilot a randomized clinical trial designed to improve the sleep environments, sleep hygiene practices, and the duration and quality of sleep of children and parents in low-income families. It is hypothesized that child and parent sleep (assessed through subjective reports of sleep, sleep environments, sleep hygiene practices, and objective sleep data via sleep actigraphy collected with Fitbit watches) in the intervention group will improve between Week 2 (intervention session) and Week 4 (post-intervention session) as compared to child and parent sleep in the waitlist-control group.

Conditions

  • Sleep Problems
  • Sleep Hygiene

Interventions

BEHAVIORAL

Good Nights Sleep Program

The Good Nights Sleep Program arm adapts established evidence-based motivational practices to change child and family sleep environments and sleep hygiene practices. At Week 0, participants will provide a comprehensive assessment of sleep environment and sleep hygiene practices and will be issued a Fitbit watch to wear for the duration of the study. At Week 2, participants will receive information about the benefits of good sleep, feedback about their sleep environment and sleep hygiene practices based on the Week 0 assessment data to implement at home, and sleep environment modification items based on participant-identified areas of need (e.g., a fan, sound machine, bedding). At Week 4, families in the Good Nights Sleep Program arm will provide post-intervention assessment data and feedback on the intervention and families in the Waitlist-Control arm can elect to receive the intervention if they choose to.

Sponsors & Collaborators

  • Auburn University

    lead OTHER

Principal Investigators

  • James B Hinnant · Auburn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-09-01
Completion
2024-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249217 on ClinicalTrials.gov