Sleeping Healthy, Living Healthy for Insomnia

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JB

Jean-Marie Bruzzese, PhD

Principal Investigator

Professor of Developmental Psychology (in Nursing) at Columbia University

Are You a Good Fit for This Trial?

This trial is for urban adolescents who are getting less sleep than recommended for their age. Participants will be students from NYC public high schools. There are no detailed exclusion criteria listed.

Inclusion Criteria

I am a 9th-11th grader in NYC public school with poor sleep on school nights.

Exclusion Criteria

I am a pregnant teenager experiencing stress and sleep changes.
I have been diagnosed with a sleep disorder.
I am not in 12th grade this year.
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What Are the Treatments Tested in This Trial?

Interventions

  • Sleep for Teens
  • Sleeping Healthy, Living Healthy (SHLH)

Trial Overview

The study tests 'Sleeping Healthy, Living Healthy' (SHLH), a program that teaches healthy sleep habits and mind-body techniques, compared to another school-based sleep education program. Students are randomly assigned to groups and followed for one year.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Sleeping Healthy, Living Healthy (SHLH) InterventionExperimental Treatment1 Intervention
Group II: Sleep for Teens InterventionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+