Parent Intervention to Improve Child Sleep
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Intervention feasibility: recruitment screening eligibility [Through study completion, an average of 2 years]
Percent of children screened who were eligible
- Intervention feasibility: recruitment screening enrollment [Through study completion, an average of 2 years]
Percent of children screened who were enrolled
- Intervention feasibility: recruitment duration [Through study completion, an average of 2 years]
Duration to reach the target sample
- Intervention feasibility: Enrollment yield for each recruitment strategy [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 [Through study completion, an average of 2 years]
Percent attendance at assessment visits
- Intervention feasibility: retention percentage [Through study completion, an average of 2 years]
Percent of sample retained at post-intervention
- Intervention feasibility: retention dropout [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 [Through study completion, an average of 2 years]
Reasons for dropping out of the study
- Intervention acceptability [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 Outcome Measures
- Process measures: Intervention attendance [Through study completion, an average of 2 years]
Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records.
- Process measures: Dose [Through study completion, an average of 2 years]
Survey checklist completed by interventionists after each intervention session that rates the extent to which the program content was addressed
- Process measure: Implementation [Through study completion, an average of 2 years]
Survey checklist completed by interventionists after each intervention session that assess implementation barriers
- Process measure: Engagement [Through study completion, an average of 2 years]
Survey checklist completed by interventionists after each intervention session that assess perceived participant engagement
- Process measure: Content [Through study completion, an average of 2 years]
Survey checklist completed by interventionists after each intervention session that assess perceived appropriateness of session content
- Child sleep: night sleep duration [Baseline (0 weeks) and post-intervention (8 weeks)]
Wrist-worn actigraphy devices were used to calculate child's nighttime sleep duration
- Child sleep: daytime sleep duration [Baseline (0 weeks) and post-intervention (8 weeks)]
Wrist-worn actigraphy devices were used to calculate child's daytime sleep duration
- Child sleep: 24-hour sleep duration [Baseline (0 weeks) and post-intervention (8 weeks)]
Wrist-worn actigraphy devices were used to calculate child's 24-hour sleep duration
- Child sleep: sleep quality [Baseline (0 weeks) and post-intervention (8 weeks)]
Wrist-worn actigraphy devices were used to calculate child's sleep quality (e.g., wake after sleep onset)
- Child sleep: sleep timing [Baseline (0 weeks) and post-intervention (8 weeks)]
Wrist-worn actigraphy devices were used to calculate variability in child's sleep timing
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Parents or primary caregivers 18 years of age or older
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Have a child 2-4 years of age
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Child's 24-hour sleep duration does not meet established recommendations based on child age
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English speaking
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Annual household income <= 200% of the Federal Poverty Line or receive assistance benefits (e.g., SNAP, WIC)
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Computer or phone access for video calls
Exclusion Criteria:
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Parent or child has a medical condition that impairs their ability to participate
-
Child has a clinical sleep disorder
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of South Carolina
- Temple University
- National Institute of General Medical Sciences (NIGMS)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00123879
- 5P20GM130420