Clinical trial NCT04484649: Sleeping Healthy/Living Healthy Development
Official title: Development and Pilot Testing of Sleeping Healthy/Living Healthy, a Comprehensive Sleep Intervention for Adolescents in Urban School Based Health Center (SBHCs): Phase II or Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Psychological Stress
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 61
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Poor sleep quality, which contributes to impaired functioning, is elevated in urban, ethnic/racial minority adolescents due, in part, to poor sleep hygiene. Despite successful sleep hygiene interventions in younger children, none focus on adolescents, a group with unique developmental needs. Urban adolescents face unique contextual stressors, which may contribute to ineffective use of sleep hygiene behaviors. Mind-body integrative (MBIH) approaches (e.g. yoga, meditation) improve sleep quality in adults, but are rarely applied to adolescents. MBIH has been shown to reduce stress among adolescents. Taken together, this suggests that integrating MBIH with sleep hygiene strategies has the potential for a synergistic effect on improving sleep quality, yet no interventions concurrently use MBIH and sleep hygiene with adolescents.

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.

Primary outcomes:
measure: Average Sleep Duration (Past 2 Weeks)
timeFrame: Baseline (Day 0)
measure: Average Sleep Duration (Past 2 Weeks)
timeFrame: Immediate Post (up to 7 weeks after baseline)
measure: Average Sleep Duration (Past 2 Weeks)
timeFrame: Follow-up (up to 2.5 months)
measure: Sleep Fragmentation - Sleep Efficiency (%) (Past Month)
timeFrame: Baseline (Day 0)
measure: Sleep Fragmentation - Sleep Efficiency (%) (Past Month)
timeFrame: Immediate Post (up to 7 weeks after baseline)
measure: Sleep Fragmentation - Sleep Efficiency (%) (Past Month)
timeFrame: Follow-up (up to 2.5 months)
measure: Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
timeFrame: Baseline (Day 0)
measure: Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
timeFrame: Immediate Post (up to 7 weeks after baseline)
measure: Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
timeFrame: Follow-up (up to 2.5 months)
Secondary outcomes:
measure: Score on Pittsburgh Sleep Quality Index (PSQI Global Score)
timeFrame: Baseline (Day 0)
measure: Score on Pittsburgh Sleep Quality Index (PSQI Global Score)
timeFrame: Immediate Post (up to 7 weeks after baseline)
measure: Score on Pittsburgh Sleep Quality Index (PSQI Global Score)
timeFrame: Follow-up (up to 2.5 months)
measure: Score on the Perceived Stress Scale (PSS)
timeFrame: Baseline (Day 0)
measure: Score on the Perceived Stress Scale (PSS)
timeFrame: Immediate Post (up to 7 weeks after baseline)
measure: Score on the Perceived Stress Scale (PSS)
timeFrame: Follow-up (up to 2.5 months)
measure: Score on the PROMIS Psychological Stress Experiences Survey - T Score
timeFrame: Baseline (Day 0)
measure: Score on the PROMIS Psychological Stress Experiences Survey - T Score
timeFrame: Immediate Post (up to 7 weeks after baseline)
measure: Score on the PROMIS Psychological Stress Experiences Survey - T Score
timeFrame: Follow-up (up to 2.5 months)
measure: Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score
timeFrame: Baseline (Day 0)
measure: Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score
timeFrame: Immediate Post (up to 7 weeks after baseline)
measure: Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score
timeFrame: Follow-up (up to 2.5 months)
measure: Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score
timeFrame: Baseline (Day 0)
measure: Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score
timeFrame: Immediate Post (up to 7 weeks after baseline)
measure: Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score
timeFrame: Follow-up (up to 2.5 months)
measure: Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)
timeFrame: Baseline (Day 0)
measure: Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)
timeFrame: Immediate Post (up to 7 weeks after baseline)
measure: Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)
timeFrame: Follow-up (up to 2.5 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Samantha Garbers-Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References: