Parent Intervention to Improve Child Sleep

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Sleep Tight

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • South Carolina early childhood support state agencies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Intervention; 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.	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.
No Intervention: Comparison/control; The comparison arm is a no-contact control group. Parents and children will not receive any intervention. They will be placed on a wait-list, and then offered the sleep intervention once the post-assessments are complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention feasibility: recruitment screening eligibility	Percent of children screened who were eligible	Through study completion, an average of 2 years
Intervention feasibility: recruitment duration	Duration to reach the target sample	Through study completion, an average of 2 years
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
Intervention feasibility: retention attendance	Percent attendance at assessment visits	Through study completion, an average of 2 years
Intervention feasibility: retention percentage	Percent of sample retained at post-intervention	Through study completion, an average of 2 years
Intervention feasibility: retention dropout	Percent of sample that drops out or is lost to follow-up	Through study completion, an average of 2 years
Intervention feasibility: retention dropout reasons	Reasons for dropping out of the study	Through study completion, an average of 2 years
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
Intervention feasibility: recruitment screening enrollment	Percent of eligible children who were enrolled	Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Process measures: Intervention attendance	Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records.	Through study completion, an average of 2 years
Process measure: Implementation	Survey checklist completed by interventionists after each intervention session that assess implementation barriers	Through study completion, an average of 2 years
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
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: Temple University; National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Actual): January 3, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro00123879; 5P20GM130420 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No