Parenting Intervention to Improve Young Children's Sleep Among Families With Low Income
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sleep
- Sponsor
- University of South Carolina
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Intervention feasibility: recruitment screening eligibility
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Elizabeth Adams
Assistant Professor
University of South Carolina
Eligibility Criteria
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
Outcomes
Primary Outcomes
Intervention feasibility: recruitment screening eligibility
Time Frame: Through study completion, an average of 2 years
Percent of children screened who were eligible
Intervention feasibility: recruitment screening enrollment
Time Frame: Through study completion, an average of 2 years
Percent of eligible children who were enrolled
Intervention feasibility: recruitment duration
Time Frame: Through study completion, an average of 2 years
Duration to reach the target sample
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.
Intervention feasibility: retention attendance
Time Frame: Through study completion, an average of 2 years
Percent attendance at assessment visits
Intervention feasibility: retention percentage
Time Frame: Through study completion, an average of 2 years
Percent of sample retained at post-intervention
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
Intervention feasibility: retention dropout reasons
Time Frame: Through study completion, an average of 2 years
Reasons for dropping out of the study
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
- 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))
- 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: 24-hour sleep duration(Baseline (0 weeks) and post-intervention (6 weeks))
- Child sleep: sleep quality(Baseline (0 weeks) and post-intervention (6 weeks))
- Child sleep: sleep timing(Baseline (0 weeks) and post-intervention (6 weeks))