N/A
Completed N=15
Implementing Behavioral Sleep Intervention in Urban Primary Care
Sleep Disturbances · sleep deprivation · Sleep
Source: ClinicalTrials.gov NCT04046341 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate) — 13; 2 Participants
Summary
Investigators will enroll up to 20 participants from 3 Children's Hospital of Philadelphia (CHOP) primary care locations. The primary objective is to determine the whether the Sleep Well! behavioral sleep intervention is feasible to be implemented in primary care offices and acceptable to families. The direction and magnitude of change in child sleep from pre-intervention to post-intervention will also be examined.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate) |
13; 2 | — |
| PRIMARY Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility) |
12; 3 | — |
| PRIMARY Treatment Acceptability (Strategies) |
12 | — |
| PRIMARY Cultural Humility |
9; 1; 0 | — |
| SECONDARY Sleep Patterns and Problems: Sleep Problem |
8; 4 | .008 sig |
| SECONDARY Sleep Patterns and Problems: Sleep Onset Latency |
69.00; 25.83 | .014 sig |
| SECONDARY Sleep Patterns and Problems: Night Awakening Duration |
131.25; 27.50 | .013 sig |
| SECONDARY Sleep Patterns and Problems: Nighttime Sleep Duration |
6.63; 9.21 | .001 sig |
| SECONDARY Sleep Patterns and Problems: 24-hour Sleep Duration |
8.71; 9.98 | .209 |
Eligibility Criteria
Inclusion Criteria
- Caregiver participant is the parent or legal guardian of the child subject.
- Caregiver/legal guardian 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 diagnosed child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) 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 (NCT04046341). 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.