Poor Quality SleepNCT07893015

SHLH for Urban Adolescents (Efficacy Trial)

A study testing Sleeping Healthy, Living Healthy and Sleep for Teens in people with Poor Quality Sleep, run by Columbia University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 13 to 17 years
Conditions the study is for: Poor Quality Sleep
What is being tested?: Sleeping Healthy, Living Healthy and Sleep for Teens
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 294 participants
Where: 1 siteUnited States
Study dates: Nov 2026to Jun 2030
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

Report of a sleep disorder
Highly specialized learning needs (e.g., Down's syndrome, severe ADHD) which may preclude completion of the intervention or assessments
Pregnant adolescents because stress of an adolescent pregnancy and hormonal changes could impact sleep
12th graders because control students will not be in the school the following year to receive SHLH

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

NYC Public High Schools
New York, New York, 10032

Other trials in United States

About this study

Official title: A School-based Intervention to Improve Sleep Health in Urban Adolescents

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.

Read the detailed description

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.

Conditions: Poor Quality Sleep
Being tested: Sleeping Healthy, Living Healthy, Sleep for Teens
Keywords: Sleep health, Sleep duration, Sleep-related impairment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sleeping Healthy, Living HealthyBehavioural
Also called SHLH
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.
Sleep for TeensBehavioural
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.

Study groups in NCT07893015
Study group	Role	What they receive
Sleeping Healthy, Living Healthy (SHLH) Intervention	Experimental	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. Receives: Behavioral: Sleeping Healthy, Living Healthy
Sleep for Teens Intervention	Active comparator	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. Receives: Behavioral: Sleep for Teens

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 2 months post-intervention

Secondary outcomes (3)

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.
Measured: 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)
Measured: 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.
Measured: Up to 1 year post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2026Jun 2030

First posted23 Oct 2026
Study startNov 2026 (estimated)
Primary completionJun 2029 (estimated)
Study completionJun 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Poor Quality SleepStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 294 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07893015
Sponsor's protocol ID: ACYY1404
Other IDs: 1R61HL186023
Status last verified: Oct 2026
First submitted: 19 Oct 2026
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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