Parent Intervention to Improve Child Sleep

April 1, 2025 updated by: Elizabeth Adams, University of South Carolina

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intervention feasibility: recruitment screening eligibility
Time Frame: Through study completion, an average of 2 years
Percent of children screened who were eligible
Through study completion, an average of 2 years
Intervention feasibility: recruitment duration
Time Frame: Through study completion, an average of 2 years
Duration to reach the target sample
Through study completion, an average of 2 years
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.
Through study completion, an average of 2 years
Intervention feasibility: retention attendance
Time Frame: Through study completion, an average of 2 years
Percent attendance at assessment visits
Through study completion, an average of 2 years
Intervention feasibility: retention percentage
Time Frame: Through study completion, an average of 2 years
Percent of sample retained at post-intervention
Through study completion, an average of 2 years
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
Through study completion, an average of 2 years
Intervention feasibility: retention dropout reasons
Time Frame: Through study completion, an average of 2 years
Reasons for dropping out of the study
Through study completion, an average of 2 years
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)
Through study completion, an average of 2 years
Intervention feasibility: recruitment screening enrollment
Time Frame: Through study completion, an average of 2 years
Percent of eligible children who were enrolled
Through study completion, an average of 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 2 years
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
Through study completion, an average of 2 years
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
Through study completion, an average of 2 years
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
Baseline (0 weeks) and post-intervention (6 weeks)
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
Baseline (0 weeks) and post-intervention (6 weeks)
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
Baseline (0 weeks) and post-intervention (6 weeks)
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)
Baseline (0 weeks) and post-intervention (6 weeks)
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
Baseline (0 weeks) and post-intervention (6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Temple University
National Institute of General Medical Sciences (NIGMS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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