Parent Intervention to Improve Child Sleep

Not Applicable

Completed

• Conditions: Sleep

• Registration Number: NCT06038591
• Lead Sponsor: University of South Carolina

Brief Summary

In this study, the investigators pilot tested a parenting intervention to improve young children's sleep in families with low income. Families were randomized to an intervention or wait-list control group. The investigators hypothesized the intervention would be feasible and acceptable to enrolled families.

Detailed Description

This pilot study tested a parenting intervention to improve young children's sleep in families with low income using a randomized controlled trial (RCT) design. Parents were randomized to the intervention or wait-list control group. Intervention content was delivered in virtual sessions with a parent and interventionist. The primary aim was to examine intervention feasibility (e.g., recruitment, retention, acceptability) with a secondary goal of preliminary efficacy on intervention changes in child sleep patterns to inform a future large-scale RCT. Exploratory evidence was collected on changes in children's health behaviors (e.g., diet, screen time), and social-emotional health (e.g., behavior problems) as indicators for potential spillover effects on these domains.

Study Timeline

• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-15
• Study Start: 2024-01-08
• Primary Completion: 2025-01-03
• Study Completion: 2025-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Parents or primary caregivers 18 years of age or older
• Have a child 2-4 years of age
• Child's 24-hour sleep duration does not meet established recommendations based on child age
• English speaking
• Annual household income <= 200% of the Federal Poverty Line or receive assistance benefits (e.g., SNAP, WIC)
• Computer or phone access for video calls

Exclusion Criteria

• Parent or child has a medical condition that impairs their ability to participate
• Child has a clinical sleep disorder
• Child takes medication that significantly impacts their sleep

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention feasibility: recruitment screening eligibility	Through study completion, an average of 2 years	Percent of children screened who were eligible
Intervention feasibility: recruitment screening enrollment	Through study completion, an average of 2 years	Percent of eligible children who were enrolled
Intervention feasibility: recruitment duration	Through study completion, an average of 2 years	Duration to reach the target sample
Intervention feasibility: Enrollment yield for each recruitment strategy	Through study completion, an average of 2 years	Percent of enrolled participants that were recruited via each recruitment strategy to determine the highest and lowest yielding strategies.
Intervention feasibility: retention attendance	Through study completion, an average of 2 years	Percent attendance at assessment visits
Intervention feasibility: retention percentage	Through study completion, an average of 2 years	Percent of sample retained at post-intervention
Intervention feasibility: retention dropout	Through study completion, an average of 2 years	Percent of sample that drops out or is lost to follow-up
Intervention feasibility: retention dropout reasons	Through study completion, an average of 2 years	Reasons for dropping out of the study
Intervention acceptability	Through study completion, an average of 2 years	Acceptability will be assessed in an exit survey with Likert scale items and open-ended questions about intervention likes/dislikes and suggestions for future changes. Likert scale values range 1-5. Higher numbers indicate better outcomes (e.g., more positive acceptability)

Secondary Outcome Measures

Name	Time	Method
Child sleep: night sleep duration	Baseline (0 weeks) and post-intervention (6 weeks)	Wrist-worn actigraphy devices were used to calculate child's nighttime sleep duration
Child sleep: daytime sleep duration	Baseline (0 weeks) and post-intervention (6 weeks)	Wrist-worn actigraphy devices were used to calculate child's daytime sleep duration
Process measures: Intervention attendance	Through study completion, an average of 2 years	Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records.
Process measures: Content fidelity	Through study completion, an average of 2 years	Checklist completed by researchers for each intervention session that evaluates the extent to which the program content was addressed
Process measure: Implementation	Through study completion, an average of 2 years	Survey checklist completed by interventionists after each intervention session that assess implementation barriers
Child sleep: 24-hour sleep duration	Baseline (0 weeks) and post-intervention (6 weeks)	Wrist-worn actigraphy devices were used to calculate child's 24-hour sleep duration
Child sleep: sleep quality	Baseline (0 weeks) and post-intervention (6 weeks)	Wrist-worn actigraphy devices were used to calculate child's sleep quality (e.g., wake after sleep onset)
Child sleep: sleep timing	Baseline (0 weeks) and post-intervention (6 weeks)	Wrist-worn actigraphy devices were used to calculate variability in child's sleep timing

Trial Locations

Locations (1)

South Carolina early childhood support state agencies; 🇺🇸 Columbia, South Carolina, United States