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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Average Sleep Duration (Past 2 Weeks)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intervention
Sleeping Healthy/Living Healthy
Intervention: Sleeping Healthy/Living Healthy (Behavioral)
Control
Attention Control
Intervention: Attention Control (Behavioral)
Outcomes
Primary Outcomes
Average Sleep Duration (Past 2 Weeks)
Time Frame: Follow-up (up to 2.5 months)
Measured in actigraphy. Measured in minutes.
Sleep Fragmentation - Sleep Efficiency (%) (Past Month)
Time Frame: Follow-up (up to 2.5 months)
Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy.
Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
Time Frame: Follow-up (up to 2.5 months)
Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.
Average Sleep Duration (Past 2 Weeks)
Time Frame: Baseline (Day 0)
Measured using actigraphy. Measured in minutes.
Average Sleep Duration (Past 2 Weeks)
Time Frame: Immediate Post (up to 7 weeks after baseline)
Measured with actigraphy. Measured in minutes.
Sleep Fragmentation - Sleep Efficiency (%) (Past Month)
Time Frame: Baseline (Day 0)
Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy.
Sleep Fragmentation - Sleep Efficiency (%) (Past Month)
Time Frame: Immediate Post (up to 7 weeks after baseline)
Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy.
Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
Time Frame: Baseline (Day 0)
Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.
Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
Time Frame: Immediate Post (up to 7 weeks after baseline)
Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.
Secondary Outcomes
- Score on Pittsburgh Sleep Quality Index (PSQI Global Score)(Follow-up (up to 2.5 months))
- Score on the Perceived Stress Scale (PSS)(Follow-up (up to 2.5 months))
- Score on the PROMIS Psychological Stress Experiences Survey - T Score(Follow-up (up to 2.5 months))
- Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score(Baseline (Day 0))
- Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score(Follow-up (up to 2.5 months))
- Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score(Follow-up (up to 2.5 months))
- Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)(Follow-up (up to 2.5 months))
- Score on Pittsburgh Sleep Quality Index (PSQI Global Score)(Baseline (Day 0))
- Score on Pittsburgh Sleep Quality Index (PSQI Global Score)(Immediate Post (up to 7 weeks after baseline))
- Score on the Perceived Stress Scale (PSS)(Baseline (Day 0))
- Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score(Baseline (Day 0))
- Score on the Perceived Stress Scale (PSS)(Immediate Post (up to 7 weeks after baseline))
- Score on the PROMIS Psychological Stress Experiences Survey - T Score(Baseline (Day 0))
- Score on the PROMIS Psychological Stress Experiences Survey - T Score(Immediate Post (up to 7 weeks after baseline))
- Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score(Immediate Post (up to 7 weeks after baseline))
- Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score(Immediate Post (up to 7 weeks after baseline))
- Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)(Baseline (Day 0))
- Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)(Immediate Post (up to 7 weeks after baseline))