Sleeping Healthy/Living Healthy Development

Not Applicable

Completed

• Conditions: Sleep; Psychological Stress
• Interventions: Behavioral: Sleeping Healthy/Living Healthy; Behavioral: Attention Control

• Registration Number: NCT04484649
• Lead Sponsor: Columbia University

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 Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-23
• Study Start: 2021-10-12
• Primary Completion: 2022-06-07
• Study Completion: 2022-06-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Sleeping Healthy/Living Healthy	Sleeping Healthy/Living Healthy
Control	Attention Control	Attention Control

Primary Outcome Measures

Name	Time	Method
Average Sleep Duration (Past 2 Weeks)	Follow-up (up to 2.5 months)	Measured in actigraphy. Measured in minutes.
Sleep Fragmentation - Sleep Efficiency (%) (Past Month)	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)	Follow-up (up to 2.5 months)	Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.

Secondary Outcome Measures

Name	Time	Method
Score on Pittsburgh Sleep Quality Index (PSQI Global Score)	Follow-up (up to 2.5 months)	Subjective sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Score on the Perceived Stress Scale (PSS)	Follow-up (up to 2.5 months)	Stress will be measured using Perceived Stress Scale (past month). The PSS has 10 items, completed using self-report. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress.
Score on the PROMIS Psychological Stress Experiences Survey - T Score	Follow-up (up to 2.5 months)	Stress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences Ped Short Form (SF) v1.0 (past 7 days), an 8-item self report. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Psychological Stress Experiences, a T-score of 60 is one standard deviation (SD) worse than average.
Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score	Baseline (Day 0)	Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations.; For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average.
Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score	Follow-up (up to 2.5 months)	Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations.; For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average.
Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score	Follow-up (up to 2.5 months)	Subjective sleep-related impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep-Related Impairment Short Form 8a v1.0, an 8-item questionnaire focusing on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Adolescents rate various aspects of their sleep over the past 7 days on a 5-point frequency scale ranging from 1 (never) to 5 (always). PROMIS instruments are scored using item-level calibrations.; For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Sleep-Related Impairment, a T-score of 60 is one standard deviation (SD) worse than average.
Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)	Follow-up (up to 2.5 months)	Mindfulness will be measured using the MAAS-A, a self-reported 14-item questionnaire that measures the level of mindfulness, defined as "a receptive state of attention that, informed by an awareness of present experience, simply observes what is taking place." The MAAS-A is an adapted adolescent version of the validated Mindful Attention Awareness Scale (MAAS), which was developed for use with adult populations and considers mindfulness to be a one-dimensional construct. Using a six-point scale, ranging from 1 (almost always) to 6 (almost never), adolescents indicate how frequently or infrequently they currently have each experience. The score is the mean of the 14 items with higher scores reflecting higher trait mindfulness.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States