Sleep
Conditions
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.
Interventions
BEHAVIORALSleep 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.
Sponsors
Temple University
National Institute of General Medical Sciences (NIGMS)
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 4 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 eligible children 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Process measures: Content fidelity | 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 |
| Process measure: Implementation | Through study completion, an average of 2 years | Survey checklist completed by interventionists after each intervention session that assess implementation barriers |
| Child sleep: night sleep duration | Baseline (0 weeks) and post-intervention (6 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 (6 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 (6 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 (6 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 (6 weeks) | Wrist-worn actigraphy devices were used to calculate variability in child's sleep timing |
| Process measures: Intervention attendance | Through study completion, an average of 2 years | Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records. |
Countries
United States
Outcome results
None listed