Parent Intervention to Improve Child Sleep

NCT06038591 | Completed

• 2 other identifiers: Pro001238795P20GM130420
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (9)

• Intervention feasibility: recruitment screening eligibility

  Percent of children screened who were eligible

  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

• 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

Secondary Outcomes (8)

• Process measures: Intervention attendance

  Through study completion, an average of 2 years

• Process measures: Content fidelity

  Through study completion, an average of 2 years

• Process measure: Implementation

  Through study completion, an average of 2 years

• Child sleep: night sleep duration

  Baseline (0 weeks) and post-intervention (6 weeks)

• Child sleep: daytime sleep duration

  Baseline (0 weeks) and post-intervention (6 weeks)

Study Arms (2)

Sleep Intervention

EXPERIMENTAL

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

Comparison/control

NO INTERVENTION

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.

Interventions

Sleep Tight BEHAVIORAL

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.

Sleep Intervention

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• Temple University: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

South Carolina early childhood support state agencies

Columbia, South Carolina, 29204, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 15, 2023
• Study Start: January 8, 2024
• Primary Completion: January 3, 2025
• Study Completion: March 28, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

US (1)