SHLH for Urban Adolescents (Efficacy Trial)

NCT07893015 | Enrolling By Invitation DMC

• 2 other identifiers: ACYY14041R61HL186023
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poor Quality Sleep

Keywords

Sleep health; Sleep duration; Sleep-related impairment

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  2 months post-intervention

Secondary Outcomes (3)

• Pittsburgh Sleep Quality Index (PSQI) Global score

  Up to 1 year post-intervention

• PROMIS Pediatric Sleep Disturbance -- Short Form 8a

  Up to 1 year post-intervention

• Objective Sleep Disturbance

  Up to 1 year post-intervention

Study Arms (2)

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.

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.

Behavioral: Sleep for Teens

Interventions

Sleeping Healthy, Living Healthy BEHAVIORAL

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

Sleeping Healthy, Living Healthy (SHLH) Intervention

Sleep for Teens BEHAVIORAL

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.

Sleep for Teens Intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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

You may not qualify if:

• 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
• th graders because control students will not be in the school the following year to receive SHLH

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYC Public High Schools

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Sleep

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jean-Marie Bruzzese, PhD

  Professor of Developmental Psychology (in Nursing) at Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Applied Developmental Psychology (in Nursing)

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

US (1)