N/A
Completed N=103
Behavioral Sleep Intervention in Urban Primary Care: Aim 3
Sleep Disturbances · sleep deprivation · Sleep
Source: ClinicalTrials.gov NCT04473222 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Retention Rate (Intervention Feasibility) — 46; 4 Participants
Summary
Investigators will enroll up to 120 parent-child dyads from Children's Hospital of Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized clinical trial is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude in any change in child sleep and child behavior.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention Rate (Intervention Feasibility) |
46; 4 | — |
| PRIMARY Family Engagement (Sessions) |
4.58 | — |
| PRIMARY Family Engagement (Telephone Calls) |
4.59 | — |
| PRIMARY Treatment Acceptability |
28; 13; 2; 0; 1 | — |
| PRIMARY Treatment Acceptability: Cultural Humility |
36; 4; 1; 0; 3 | — |
| PRIMARY Assessment Process (Study Feasibility) |
50; 47; 44; 43; 39; 37 | — |
| SECONDARY Severity of Child Sleep Problems |
45; 38; 20; 33; 13; 21 | .026 sig |
| SECONDARY Child Sleep Problems: Bedtime Difficulties |
41; 36; 18; 30; 14; 22 | 0.032 sig |
| SECONDARY Child Sleep Patterns: Sleep Onset Latency |
57.00; 52.34; 31.02; 42.79; 29.13; 38.08 | .010 sig |
| SECONDARY Child Sleep Patterns: Number of Wakings Per Night |
1.84; 1.85; 1.27; 1.37; 1.02; 1.23 | 0.161 |
| SECONDARY Child Sleep Patterns: Duration of Wakings Per Night |
106.80; 71.81; 58.64; 78.49; 21.38; 89.62 | 0.006 sig |
| SECONDARY Child Sleep Patterns: Nighttime Sleep Duration |
7.58; 7.99; 8.73; 8.39; 8.73; 8.19 | 0.045 sig |
| SECONDARY Child Sleep Patterns: Total 24-hour Sleep Duration |
9.53; 9.88; 10.61; 10.18; 10.29; 10.07 | 0.685 |
| SECONDARY Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration |
8.08; 7.98; 7.96; 7.88; 8.93; 7.93 | 0.364 |
| SECONDARY Child Behavior Problems: Externalizing Problems |
50.32; 45.68; 46.41; 44.14; 44.84; 44.47 | 0.019 sig |
| SECONDARY Child Behavior Problems: Internalizing Problems |
47.39; 43.20; 44.20; 43.05; 44.54; 41.37 | 0.776 |
Eligibility Criteria
Inclusion Criteria
- Parental/guardian permission (informed consent)
- Caregiver participant is the parent or legal guardian of the child subject
- Caregiver/legal guardian is greater than or equal to 18 years of age.
- Child between the ages of 1 and 5 years.
- Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep Questionnaire item included in an eligibility screening questionnaire or child meets American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire.
- English-speaking.
Exclusion Criteria
- Caregiver is not parent or legal guardian of child participant.
- Presence of a child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical (e.g., sickle cell disease, cancer) concern in which the disorder or treatment of the disorder impact sleep.
- Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Data sourced from ClinicalTrials.gov (NCT04473222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.