Parenting Intervention to Improve Young Children's Sleep Among Families With Low Income
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of South Carolina
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Intervention feasibility: recruitment screening eligibility
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 4 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Sleep Tight (Behavioral)
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.
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))
Investigators
Elizabeth Adams
Assistant Professor
University of South Carolina