SleepSPP OTNCT06239792

Sleep Promotion Program Primary Care (SPP PC) Open Trial

A study testing Sleep Promotion Program in people with Sleep and Sleep Disturbance, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 years and older
Conditions the study is for: Sleep, Sleep Disturbance, Insufficient Sleep
What is being tested?: Sleep Promotion Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 13 May 2024to 19 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Youth:
Able and willing to provide informed assent (with consent from parent/guardian)
Ages 12-18
Currently a patient at Kids Plus Pediatrics
Currently depressed
Report short sleep duration (<7 hours on school nights) and/or weekday-weekend sleep timing difference of >=2 hours
Parents:
Parents must be age 18 or older and the parent/guardian of an enrolled youth participant and must have at least 10 hours face-to-face interaction with the youth participant per week.

Who cannot join

Youth:
Significant or unstable medical conditions
Diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder
Diagnosis of PTSD, bipolar disorder, a psychotic disorder, or substance use disorder
Currently engaged in cognitive and/or behavioral therapy that aims to improve sleep
Changes in medications that impact sleep in the month prior to screening

Show all 13Show fewer

Active suicidality requiring immediate treatment
Unable or unwilling to comply with study procedures
Have any physical or mental condition that would preclude study participation.
Parents will be excluded if they:
Express active suicidality that requires immediate treatment;
Have any physical or mental condition that would preclude study participation; OR
Are unable or unwilling to comply with study procedures.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15217

Other trials in United States

About this study

Official title: A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care Open Trial

Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on one individual session and smart phone technology to deliver evidence-based strategies. This open trial portion of the R34 will focus on conducting an open trial (n=8) to iteratively refine provider training, implementation procedures, and SPP program, per participant and staff feedback.

Conditions: Sleep, Sleep Disturbance, Insufficient Sleep
Being tested: Sleep Promotion Program
Medical subject headings: Parasomnias, Sleep Deprivation

What participants receive

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

Sleep Promotion ProgramBehavioural
Also called SPP
SPP prioritizes increasing sleep duration and regularizing sleep-wake timing. The provider and youth review the youth's sleep pattern, based on sleep diary data collected before and during the program and actigraphy data collected at baseline. They discuss benefits to the current sleep pattern, reasons for changing sleep, and they create an action plan. Psychoeducation about healthy sleep is offered via a handout developed by our group. Youth and provider jointly select SPP strategies relevant to the contributors to poor sleep for each youth (e.g., time management, limiting weekend oversleep). In the second session they review progress and adjust the plan. Parents participate for part of each session to learn about their child's sleep and to discuss ways they can support their child to make the planned changes.

Study groups in NCT06239792
Study group	Role	What they receive
Sleep Promotion Program	Experimental	Participants will receive the Sleep Promotion Program (SPP), consisting of 2 individual sessions with a clinician via telehealth (or in-person if desired), about 2 weeks apart, and web-based intervention components. Receives: Behavioral: Sleep Promotion Program

What is being measured

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

Feasibility of Intervention Measure
The Feasibility of Intervention Measure (FIM) is a 4-item measure that assesses the feasibility of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5. Higher score indicates more feasible.
Measured: Post-Intervention (~8 weeks)
Acceptability of Intervention Measure
The Acceptability of Intervention Measure (AIM) is a 4-item measure that assesses the acceptability of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5. Higher scores indicate higher acceptability.
Measured: Post-Intervention (~8 weeks)
Intervention Appropriateness Measure
The Intervention Appropriateness Measure (IAM) is a 4-item measure that assesses the appropriateness of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5. Higher scores indicate higher appropriateness.
Measured: Post-Intervention (~8 weeks)
Clinical Global Impressions Scale - Improvement
This is a clinician rating of improvement in sleep and psychopathology. Clinicians rate domains of sleep health, psychiatric symptoms, and overall health on a range from 1 very much improved) to 7 (very much worse). A score of 0 indicates no assessment. Scores for each domain are reported individually. Only adolescent responses were used to inform this measure, so it is reflected only for adolescent participants. Data to calculate the sleep health outcome is not available as the measured used to calculate this outcome (Munich Chronotype Questionnaire( was inadvertently omitted from our survey at Post-Intervention). Thus, we cannot report on the sleep health domain, nor the overall health domain as this relies on the sleep health domain. Thus, values reported below reflect only the psychiatric symptoms domain.
Measured: Post-Intervention (~8 weeks)
Patient Health Questionnaire - 9 - M
This is a self-report measure of depressive symptoms. It consists of 9 items rated 0 (not at all) to 3 (nearly every day) over the past 2 weeks. Scores on those 9 items are summed to create a total score (0-27, higher score indicates greater depression). Only adolescent participants completed this measure.
Measured: Change Screening to Post-Intervention (~10 weeks)

Timeline

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

13 May 202419 May 2025

First posted2 Feb 2024
Study start13 May 2024
Primary completion19 May 2025
Study completion19 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SleepStudies of the same condition, open and under way.
More trials run by University of PittsburghThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06239792
Sponsor's protocol ID: STUDY23010211 (Open)
Other IDs: R34MH132724
Acronym: SPP OT
Status last verified: Jun 2026
First submitted: 24 Jan 2024
Last updated: 2 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: In accordance with the National Insitute of Mental Health (NIMH) Data Archive Data Use Certification, investigators will share data collected as part of this proposal with outside investigators. To access data from this study, outside investigators will be asked to submit a proposal that incudes project aims and hypotheses, variables and analytic approach, and rationale for the proposed analysis. The proposal would also include information on how and where the data will be used, investigators' qualifications, timeframe in which data will be analyzed/submitted/published, source of financial support, and conflict of interest statement. They will be asked to sign a data sharing agreement and confidentiality statement prior to the sharing of this data.

Want to know more?

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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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care Open Trial
ClinicalTrials.gov ID: NCT06239792
Acronym / sponsor ID: SPP OT / STUDY23010211 (Open)
Conditions: Sleep, Sleep Disturbance, Insufficient Sleep
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 13 May 2024 (actual)
Primary completion: 19 May 2025 (actual)
Study completion: 19 May 2025 (actual)
First posted: 2 Feb 2024 (actual)
Results: Posted 2 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sleep Promotion Program	Experimental	Behavioral: Sleep Promotion ProgramParticipants will receive the Sleep Promotion Program (SPP), consisting of 2 individual sessions with a clinician via telehealth (or in-person if desired), about 2 weeks apart, and web-based intervention components.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Able and willing to provide informed assent (with consent from parent/guardian)
Ages 12-18
Currently a patient at Kids Plus Pediatrics
Currently depressed
Report short sleep duration (<7 hours on school nights) and/or weekday-weekend sleep timing difference of >=2 hours

Key exclusion criteria (13 listed)

Significant or unstable medical conditions
Diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder
Diagnosis of PTSD, bipolar disorder, a psychotic disorder, or substance use disorder
Currently engaged in cognitive and/or behavioral therapy that aims to improve sleep
Changes in medications that impact sleep in the month prior to screening

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
Sleep Promotion ProgramAlso: SPPSPP prioritizes increasing sleep duration and regularizing sleep-wake timing. The provider and youth review the youth's sleep pattern, based on sleep diary data collected before and during the program and actigraphy data collected at baseline. They discuss benefits to the current sleep pattern, reasons for changing sleep, and they create an action plan. Psychoeducation about healthy sleep is offered via a handout developed by our group. Youth and provider jointly select SPP strategies relevant to the contributors to poor sleep for each youth (e.g., time management, limiting weekend oversleep). In the second session they review progress and adjust the plan. Parents participate for part of each session to learn about their child's sleep and to discuss ways they can support their child to make the planned changes.	Behavioural	Sleep Promotion Program

Primary outcome

Feasibility of Intervention Measure
Time frame: Post-Intervention (~8 weeks)
The Feasibility of Intervention Measure (FIM) is a 4-item measure that assesses the feasibility of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5. Higher score indicates more feasible.
Acceptability of Intervention Measure
Time frame: Post-Intervention (~8 weeks)
The Acceptability of Intervention Measure (AIM) is a 4-item measure that assesses the acceptability of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5. Higher scores indicate higher acceptability.
Intervention Appropriateness Measure
Time frame: Post-Intervention (~8 weeks)
The Intervention Appropriateness Measure (IAM) is a 4-item measure that assesses the appropriateness of the intervention, each item is scored on a 1-5 likert scale (completely disagree to completely agree). Items can be evaluated individually or a scale can be created by averaging responses. Scale values range from 1-5. Higher scores indicate higher appropriateness.
Clinical Global Impressions Scale - Improvement
Time frame: Post-Intervention (~8 weeks)
This is a clinician rating of improvement in sleep and psychopathology. Clinicians rate domains of sleep health, psychiatric symptoms, and overall health on a range from 1 very much improved) to 7 (very much worse). A score of 0 indicates no assessment. Scores for each domain are reported individually. Only adolescent responses were used to inform this measure, so it is reflected only for adolescent participants. Data to calculate the sleep health outcome is not available as the measured used to calculate this outcome (Munich Chronotype Questionnaire( was inadvertently omitted from our survey at Post-Intervention). Thus, we cannot report on the sleep health domain, nor the overall health domain as this relies on the sleep health domain. Thus, values reported below reflect only the psychiatric symptoms domain.
Patient Health Questionnaire - 9 - M
Time frame: Change Screening to Post-Intervention (~10 weeks)
This is a self-report measure of depressive symptoms. It consists of 9 items rated 0 (not at all) to 3 (nearly every day) over the past 2 weeks. Scores on those 9 items are summed to create a total score (0-27, higher score indicates greater depression). Only adolescent participants completed this measure.

Results and safety

Results posted to the registry on 2 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sleep Promotion Program Adolescents	8	8
Sleep Promotion Program Parents	8	8

Primary outcome: Feasibility of Intervention Measure

Time frame: Post-Intervention (~8 weeks). Mean (Standard Deviation). Unit: Total Score

Measure	Sleep Promotion Program Adolescent n = 7	Sleep Promotion Program Parent n = 3
Value	4.07 (.043)	4.67 (0.58)

Population analysed: Some participants did not complete this measure.

Primary outcome: Acceptability of Intervention Measure

Time frame: Post-Intervention (~8 weeks). Mean (Standard Deviation). Unit: Total Score

Measure	Sleep Promotion Program Adolescent n = 7	Sleep Promotion Program Parent n = 3
Value	3.75 (0.65)	4.67 (0.56)

Population analysed: Some participants did not complete this measure.

Primary outcome: Intervention Appropriateness Measure

Time frame: Post-Intervention (~8 weeks). Mean (Standard Deviation). Unit: Total Score

Measure	Sleep Promotion Program Adolescents n = 6	Sleep Promotion Program Parent n = 3
Value	4.29 (0.84)	4.13 (0.46)

Population analysed: Some participants did not complete this measure.

Primary outcome: Clinical Global Impressions Scale - Improvement

Time frame: Post-Intervention (~8 weeks). Mean (Standard Deviation). Unit: Total Score

Measure	Sleep Promotion Program Adolescent n = 7
Value	4.57 (1.99)

Population analysed: Only youth complete this measure, however one youth participant did not have sufficient data on this measure.

Adverse events

Time frame: Screening through Post-Intervention Follow-Up (typically about 12 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sleep Promotion Program Adolescent	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8

Limitations and caveats (from the sponsor): This is an open trial with a small sample size and all participants received the SPP. Results pertaining to psychopathology may have limited generalizability.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. In accordance with the National Insitute of Mental Health (NIMH) Data Archive Data Use Certification, investigators will share data collected as part of this proposal with outside investigators. To access data from this study, outside investigators will be asked to submit a proposal that incudes project aims and hypotheses, variables and analytic approach, and rationale for the proposed analysis. The proposal would also include information on how and where the data will be used, investigators' qualifications, timeframe in which data will be analyzed/submitted/published, source of financial support, and conflict of interest statement. They will be asked to sign a data sharing agreement and confidentiality statement prior to the sharing of this data.

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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. This study is not recruiting at the moment.

Jessica C Levenson principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Promotion Program in people with Sleep and Sleep Disturbance, run by University of Pittsburgh 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 2 Jul 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?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of Intervention Measure (time frame: Post-Intervention (~8 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06239792.

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 2 Jul 2026.