N/A
Completed N=61
Sleeping Healthy/Living Healthy Development
Sleep · Psychological Stress
Source: ClinicalTrials.gov NCT04484649 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Average Sleep Duration (Past 2 Weeks) — 404.2418126; 394.9457195 minutes
Summary
This pilot study will: (1) develop Sleeping Healthy/Living Healthy, a school-based health center (SBHC) intervention that combines MBIH and sleep hygiene strategies to improve sleep quality in urban adolescents with poor sleep quality; (2) evaluate the feasibility and acceptability of intervention procedures; and (3) assess the preliminary intervention effects on sleep quality in urban adolescents.
This study includes a development phase and a pilot individually-randomized group treatment (IRGT) phase. In Year 1, the investigators will develop the novel integrated intervention using an iterative participatory design process. In Year 2, the investigators will conduct an IRGT trial with 60 adolescents with insufficient sleep recruited from two SBHCs in New York City. Adolescents will be randomized 1:1 to receive the intervention or an attention control of equal intensity and duration. Process evaluation interviews guided by a rigorous fidelity framework with adolescents and with SBHC providers and personnel will be conducted to obtain feedback regarding intervention procedures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Sleep Duration (Past 2 Weeks) |
408.5679825; 395.8340439 | — |
| PRIMARY Sleep Fragmentation - Sleep Efficiency (%) (Past Month) |
89.2803736; 88.4959747 | — |
| PRIMARY Sleep Fragmentation - Number of Sleep Disruptions (Past Month) |
33.7649958; 32.9682422 | — |
| SECONDARY Score on Pittsburgh Sleep Quality Index (PSQI Global Score) |
6.07; 4.59 | — |
| SECONDARY Score on the Perceived Stress Scale (PSS) |
28.64; 26.07 | — |
| SECONDARY Score on the PROMIS Psychological Stress Experiences Survey - T Score |
59.15; 57.83 | — |
| SECONDARY Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score |
52.82; 53.63 | — |
| SECONDARY Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score |
51.79; 51.48 | — |
| SECONDARY Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score |
59.68; 53.22 | — |
| SECONDARY Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents) |
4.05; 4.45 | — |
Eligibility Criteria
Inclusion Criteria
- Age 13.0 -17.9;
- Grade 9 - 11;
- Currently enrolled as a patient in one of the participating SBHCs; and
- Report sleep duration < 8 hours (below the minimally recommended number of hours of sleep for this age group through the following questions: What time do you: a) usually fall asleep on weekdays and b) usually wake up on weekdays?).
Exclusion Criteria
- Report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, or periodic limb movement;
- Significant developmental delay and/or severe psychiatric or medical conditions that preclude completion of study procedures or confound analyses; or
- Not capable of communicating (reading, speaking, writing) in English.
Data sourced from ClinicalTrials.gov (NCT04484649). 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.