An interventional study of Sleeping Healthy, Living Healthy and Sleep for Teens in Poor Quality Sleep, sponsored by Columbia University. Enrolling by invitation at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
The overall study goal is to test the efficacy and cost-effectiveness of Sleeping Healthy, Living Healthy (SHLH), a novel intervention that combines healthy sleep practices with mind-body integrative health (MBIH) approaches to improve sleep health among urban adolescents. The study will also use a mixed-methods multi-stakeholder process evaluation to understand barriers and facilitators to adoption and implementation of SHLH across geographically diverse high schools, and to inform future dissemination and scale-up efforts.
Aim #1: To evaluate the efficacy of SHLH in 294 urban adolescents with lower than recommended sleep duration for age. The study will randomize students from 12 NYC public high schools over 3 years, following them at four timepoints for 1-year post-intervention. While adolescents are the primary respondent for all outcomes, caregivers will be interviewed at the same intervals. School attendance data and grades will be obtained from schools.
Aim #2: To assess the cost-effectiveness of SHLH compared to an attention control sleep intervention from the school system and societal perspectives. Outcomes will be cost per day of school absences and tardiness avoided (school system perspective) and cost per quality-adjusted life year (QALY) gained (societal perspective).
Aim #3: To track the extent of uptake and delivery of SHLH across students and schools, and to identify multi-level factors that influence the implementation of SHLH, with the goal of informing future dissemination and scale-up of SHLH.
This study addresses the important problem of poor sleep health and its adverse effect on urban adolescents. To impact public health and bring changes to care, cost-effectiveness data and an understanding of factors involved in adopting and ultimately scaling-up interventions are essential to this process, but these data and understandings are lacking in sleep intervention research.
Despite poor sleep health being a significant problem among urban adolescents, few interventions target this age group. This study will test the efficacy and cost-effectiveness of Sleeping Healthy, Living Healthy, a high school-based intervention, in urban adolescents with poor sleep health and will examine factors associated with its delivery. This project has considerable public health relevance because (1) it integrates sleep behaviors with mind-body integrative health, which has the potential to greatly improve sleep in an understudied population; (2) it is delivered in high schools, maximizing the potential for the intervention to be sustained; and (3) it will inform strategies for the widespread implementation of the intervention.
Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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- 9th-11th grade students (ages 13 - 17.9) who report poor sleep duration (\<8 hours per weeknight; the recommended number of hours of sleep for adolescents) and impaired sleep duration (PROMIS SRI scores > or = 55) from up to public high schools located in NYC
Exclusion Criteria:
Adolescents randomized to the intervention group will receive SHLH. Grounded in social cognitive theory and motivational interviewing, SHLH consists of six group sessions. Each session intermixes didactic instruction, group activities, and discussions, and uses motivational interviewing skills, including open-ended questions, affirmations, reflective listening and summaries. Sessions are spaced one week apart to allow students time to practice the techniques and to build their self-efficacy in using them.
Behavioral: Sleeping Healthy, Living Healthy
Adolescents randomized to the attention control group will receive Sleep for Teens. Developed by study investigators during a pilot study at Columbia University, it meets the requirements for a comparison treatment for testing behavioral interventions: equivalent in contact time, credible, interesting, and exerts limited treatment effects. In 6 weekly sessions, adolescents learn the importance of sleep and some behavioral sleep strategies. They also learn about other topics relevant to adolescents and how they impact sleep.
Behavioral: Sleep for Teens
Program 1: Group sessions progressively educate about each topic, building on concepts learned in prior sessions. Adolescents share experiences with the new behaviors taught; facilitators offer personalized feedback to ensure adolescents interpret the experiences correctly and positively, thereby increasing their skills and self-efficacy. Informational summary handouts are given to adolescents after each session. Adolescents will also participate in group activities and receive guided discussions, with teaching of MBIH techniques.
Also known as: SHLH
Program 2: Sleep for Teens offers a similar format as SHLH, which allows control for non-specific treatment factors. However, control students receive information about sleep in lecture format. Informational summary handout will be given. However, adolescents will not participate in group activities or receive guided discussions. MBIH techniques are not taught.
PROMIS Sleep-Related Impairment (SRI) t-score
This measure assess adolescent-reported sleep-related impairment. The PROMIS Sleep-Related Impairment (SRI) is an 8-item questionnaire with a standardized, metric score (mean = 50, SD = 10) that reflects the severity of daytime consequences of poor sleep, such as sleepiness, tiredness, and functional limitations, with higher scores indicating greater impairment.
Time frame: 2 months post-intervention
Average length of sleep duration
This is an objective measure of nightly total sleep time (i.e., minutes asleep, excluding wake after sleep onset) as measured by a wrist-worn Fitbit Inspire 3. The Fitbit estimates sleep from accelerometry and photoplethysmography-derived heart rate. Fitbit data will be corroborated with a Consensus Sleep Diary (CSD).
Time frame: 2 months post-intervention
Pittsburgh Sleep Quality Index (PSQI) Global score
This is to measure sleep quality. The PSQI consists of 19 self-rated questions that evaluate various aspects of sleep quality, categorized into seven components. Each component is scored from 0 to 3, with 0 indicating no difficulty and 3 indicating severe difficulty.
Time frame: Up to 1 year post-intervention
PROMIS Pediatric Sleep Disturbance -- Short Form 8a
This scale measures adolescent-reported sleep disturbances. On a 5-point likert-type scale, adolescents report the the extent to which they experienced sleep problems in the past 7 days (1 = never to 5 = always)
Time frame: Up to 1 year post-intervention
Objective Sleep Disturbance
Objective nightly minutes awake after sleep onset (WASO) and number of awakenings, as estimated by the Fitbit Inspire 3 from accelerometry and heart rate.
Time frame: Up to 1 year post-intervention
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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