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Completed

NCT Number: NCT06038591

Parent Intervention to Improve Child Sleep

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.

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Key information

Conditions

Sleep

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Carolina early childhood support state agencies

Columbia, South Carolina, 29204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Intervention feasibility: recruitment screening eligibility

    Time frame: Through study completion, an average of 2 years

    Percent of children screened who were eligible

  2. Intervention feasibility: recruitment screening enrollment

    Time frame: Through study completion, an average of 2 years

    Percent of eligible children who were enrolled

  3. Intervention feasibility: recruitment duration

    Time frame: Through study completion, an average of 2 years

    Duration to reach the target sample

  4. Intervention feasibility: Enrollment yield for each recruitment strategy

    Time frame: 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.

  5. Intervention feasibility: retention attendance

    Time frame: Through study completion, an average of 2 years

    Percent attendance at assessment visits

  6. Intervention feasibility: retention percentage

    Time frame: Through study completion, an average of 2 years

    Percent of sample retained at post-intervention

  7. Intervention feasibility: retention dropout

    Time frame: Through study completion, an average of 2 years

    Percent of sample that drops out or is lost to follow-up

  8. Intervention feasibility: retention dropout reasons

    Time frame: Through study completion, an average of 2 years

    Reasons for dropping out of the study

  9. Intervention acceptability

    Time frame: 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 outcomes

  1. Process measures: Intervention attendance

    Time frame: Through study completion, an average of 2 years

    Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records.

  2. Process measures: Content fidelity

    Time frame: 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

  3. Process measure: Implementation

    Time frame: Through study completion, an average of 2 years

    Survey checklist completed by interventionists after each intervention session that assess implementation barriers

  4. Child sleep: night sleep duration

    Time frame: Baseline (0 weeks) and post-intervention (6 weeks)

    Wrist-worn actigraphy devices were used to calculate child's nighttime sleep duration

  5. Child sleep: daytime sleep duration

    Time frame: Baseline (0 weeks) and post-intervention (6 weeks)

    Wrist-worn actigraphy devices were used to calculate child's daytime sleep duration

  6. Child sleep: 24-hour sleep duration

    Time frame: Baseline (0 weeks) and post-intervention (6 weeks)

    Wrist-worn actigraphy devices were used to calculate child's 24-hour sleep duration

  7. Child sleep: sleep quality

    Time frame: 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)

  8. Child sleep: sleep timing

    Time frame: Baseline (0 weeks) and post-intervention (6 weeks)

    Wrist-worn actigraphy devices were used to calculate variability in child's sleep timing

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • Temple University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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