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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20GM130420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Temple University | OTHER |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Intervention | Experimental | 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. |
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| Comparison/control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Tight | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention feasibility: recruitment screening eligibility | Percent of children screened who were eligible | Through study completion, an average of 2 years |
| Intervention feasibility: recruitment screening enrollment | Percent of eligible children who were enrolled | Through study completion, an average of 2 years |
| Intervention feasibility: recruitment duration | Duration to reach the target sample | Through study completion, an average of 2 years |
| Intervention feasibility: Enrollment yield for each recruitment strategy | 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 | Percent attendance at assessment visits | Through study completion, an average of 2 years |
| Intervention feasibility: retention percentage | Percent of sample retained at post-intervention | Through study completion, an average of 2 years |
| Intervention feasibility: retention dropout | Percent of sample that drops out or is lost to follow-up | Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Process measures: Intervention attendance | Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records. | Through study completion, an average of 2 years |
| Process measures: Content fidelity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Carolina early childhood support state agencies | Columbia | South Carolina | 29204 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 23, 2025 | |
| Reset | Jan 14, 2026 | |
| Release | Jan 22, 2026 | |
| Reset | Feb 9, 2026 | |
| Release | Apr 7, 2026 | |
| Reset | Apr 28, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 23, 2025 | Jan 14, 2026 | |||
| Jan 22, 2026 |
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| Intervention feasibility: retention dropout reasons | Reasons for dropping out of the study | Through study completion, an average of 2 years |
| Intervention acceptability | 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 |
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 |
| Process measure: Implementation | Survey checklist completed by interventionists after each intervention session that assess implementation barriers | Through study completion, an average of 2 years |
| Child sleep: night sleep duration | 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 | 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 | 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 | 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 | Wrist-worn actigraphy devices were used to calculate variability in child's sleep timing | Baseline (0 weeks) and post-intervention (6 weeks) |
| Feb 9, 2026 |
| Apr 7, 2026 | Apr 28, 2026 |