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ENROLLING BY INVITATION
NCT07893015
NA

SHLH for Urban Adolescents (Efficacy Trial)

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

13 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

294

Start Date

2026-11

Completion Date

2030-06

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

BEHAVIORAL

Sleeping Healthy, Living Healthy

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.

BEHAVIORAL

Sleep for Teens

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.

Locations (1)

NYC Public High Schools

New York, New York, United States