Parent Intervention to Improve Child Sleep

Sleep Clinical Trial

Official title:

Parenting Intervention to Improve Young Children's Sleep Among Families With Low Income

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038591
• Other study ID #: Pro00123879
• Secondary ID: 5P20GM130420
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: December 19, 2025

Study information

• Verified date: January 2024
• Source: University of South Carolina
• Contact: Elizabeth Adams, PhD
• Phone: 803-777-0269
• Email: elizabeth-adams[@]sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 19, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Sleep Tight
The sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment.

Locations

Country	Name	City	State
United States	South Carolina early childhood support state agencies	Columbia	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of South Carolina	National Institute of General Medical Sciences (NIGMS), Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention feasibility: recruitment screening eligibility	Percent of children screened who were eligible	Through study completion, an average of 2 years
Primary	Intervention feasibility: recruitment screening enrollment	Percent of eligible children who were enrolled	Through study completion, an average of 2 years
Primary	Intervention feasibility: recruitment duration	Duration to reach the target sample	Through study completion, an average of 2 years
Primary	Intervention feasibility: Enrollment yield for each recruitment strategy	Percent of enrolled participants that were recruited via each recruitment strategy to determine the highest and lowest yielding strategies.	Through study completion, an average of 2 years
Primary	Intervention feasibility: retention attendance	Percent attendance at assessment visits	Through study completion, an average of 2 years
Primary	Intervention feasibility: retention percentage	Percent of sample retained at post-intervention	Through study completion, an average of 2 years
Primary	Intervention feasibility: retention dropout	Percent of sample that drops out or is lost to follow-up	Through study completion, an average of 2 years
Primary	Intervention feasibility: retention dropout reasons	Reasons for dropping out of the study	Through study completion, an average of 2 years
Primary	Intervention acceptability	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)	Through study completion, an average of 2 years
Secondary	Process measures: Intervention attendance	Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records.	Through study completion, an average of 2 years
Secondary	Process measures: Content fidelity	Checklist completed by researchers for each intervention session that evaluates the extent to which the program content was addressed	Through study completion, an average of 2 years
Secondary	Process measure: Implementation	Survey checklist completed by interventionists after each intervention session that assess implementation barriers	Through study completion, an average of 2 years
Secondary	Child sleep: night sleep duration	Wrist-worn actigraphy devices were used to calculate child's nighttime sleep duration	Baseline (0 weeks) and post-intervention (6 weeks)
Secondary	Child sleep: daytime sleep duration	Wrist-worn actigraphy devices were used to calculate child's daytime sleep duration	Baseline (0 weeks) and post-intervention (6 weeks)
Secondary	Child sleep: 24-hour sleep duration	Wrist-worn actigraphy devices were used to calculate child's 24-hour sleep duration	Baseline (0 weeks) and post-intervention (6 weeks)
Secondary	Child sleep: sleep quality	Wrist-worn actigraphy devices were used to calculate child's sleep quality (e.g., wake after sleep onset)	Baseline (0 weeks) and post-intervention (6 weeks)
Secondary	Child sleep: sleep timing	Wrist-worn actigraphy devices were used to calculate variability in child's sleep timing	Baseline (0 weeks) and post-intervention (6 weeks)