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.
Trial 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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
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.
Read more
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jean-Marie Bruzzese, Columbia University
- Investigators
- Jean-Marie Bruzzese, PhD, Principal investigator, Professor of Developmental Psychology (in Nursing) at Columbia University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School-based Intervention to Improve Sleep Health in Urban Adolescents
- ClinicalTrials.gov ID
- NCT07893015
- Acronym / sponsor ID
- ACYY1404
- Conditions
- Poor Quality Sleep
- Keywords
- Sleep health, Sleep duration, Sleep-related impairment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeping Healthy, Living Healthy (SHLH) Intervention | Experimental | Behavioral: Sleeping Healthy, Living HealthyAdolescents 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. |
| Sleep for Teens Intervention | Active comparator | Behavioral: Sleep for TeensAdolescents 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeping Healthy, Living HealthyAlso: SHLHProgram 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. | Behavioural | Sleeping Healthy, Living Healthy (SHLH) Intervention |
| Sleep for TeensProgram 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. | Behavioural | Sleep for Teens Intervention |
Primary outcome
PROMIS Sleep-Related Impairment (SRI) t-score
Time frame: 2 months post-intervention
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.
Average length of sleep duration
Time frame: 2 months post-intervention
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).
3 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI) Global score
Time frame: Up to 1 year post-intervention
PROMIS Pediatric Sleep Disturbance -- Short Form 8a
Time frame: Up to 1 year post-intervention
Objective Sleep Disturbance
Time frame: Up to 1 year post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Marie Bruzzese, PhD principal investigator
Professor of Developmental Psychology (in Nursing) at Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Sleep-Related Impairment (SRI) t-score (time frame: 2 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.