Good Nights Sleep Program to Improve Child and Family Sleep

NCT06249217 | Active Not Recruiting Phase 1

• 1 other identifier: 23-562 FB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleep problems; Sleep hygiene

Outcome Measures

Primary Outcomes (2)

• Actigraphic sleep measures

  Objective sleep will be measured via sleep actigraphy collected on Fitbit watches.

  One month total. Objective sleep measured daily.

• Subjective sleep measures

  Sleep quality will be measured via validated self-report surveys.

  One month total. Sleep quality measured at Week 0, Week 2, and Week 4.

Secondary Outcomes (2)

• Sleep environments

  One month total. Sleep environments measured at Week 0, Week 2, and Week 4.

• Sleep hygiene behaviors

  One month total. Sleep hygiene behaviors measured at Week 0, Week 2, and Week 4.

Study Arms (2)

Experimental

EXPERIMENTAL

At Week 0, participants will provide a comprehensive assessment of sleep environment and sleep hygiene practices and participants will be given 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 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 intervention group will provide post-intervention assessment data and feedback on the intervention.

Behavioral: Good Nights Sleep Program

Waitlist control

NO INTERVENTION

The waitlist control group will not receive the sleep intervention at Week 2 but families in the waitlist-control group can elect to receive the intervention if they choose to after Week 4.

Interventions

Good Nights Sleep Program BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children be eligible for free or reduced school lunch
• parents and children can speak and read in English

You may not qualify if:

• diagnosed medical sleep disorder of child or parent

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Room 266, ARTF Building, 570 Devall Drive

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

Parasomnias; Sleep Hygiene

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Health Behavior; Behavior

Study Officials

• James B Hinnant

  Auburn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The research design is a between-subjects experiment with pre- and post-intervention assessments. Random assignment to conditions will help to ensure that the intervention or waitlist control groups are equivalent prior to the intervention and that any subsequent changes are not due to initial group differences.

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 8, 2024
• Study Start: February 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

US (1)