Trial Outcomes & Findings for Sleep Promotion Program Primary Care (SPP PC) Open Trial (NCT NCT06239792)
NCT ID: NCT06239792
Last Updated: 2026-07-02
Results Overview
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.
COMPLETED
NA
16 participants
Post-Intervention (~8 weeks)
2026-07-02
Participant Flow
All participants in this trial received the Sleep Promotion Program (SPP).
Participant milestones
| Measure |
Sleep Promotion Program Adolescents
Adolescent 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.
|
Sleep Promotion Program Parents
Parent 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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep Promotion Program Primary Care (SPP PC) Open Trial
Baseline characteristics by cohort
| Measure |
Sleep Promotion Program Adolescents
n=8 Participants
Adolescent 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.
|
Sleep Promotion Program Parents
n=8 Participants
Parent 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.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15 Years
STANDARD_DEVIATION 1.6 • n=20 Participants
|
49 Years
STANDARD_DEVIATION 6.78 • n=20 Participants
|
32 Years
STANDARD_DEVIATION 18.19 • n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Post-Intervention (~8 weeks)Population: Some participants did not complete this 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.
Outcome measures
| Measure |
Sleep Promotion Program Adolescent
n=7 Participants
Adolescent 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.
|
Sleep Promotion Program Parent
n=3 Participants
Parent 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.
|
|---|---|---|
|
Feasibility of Intervention Measure
|
4.07 Total Score
Standard Deviation .043
|
4.67 Total Score
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: Post-Intervention (~8 weeks)Population: Some participants did not complete this 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.
Outcome measures
| Measure |
Sleep Promotion Program Adolescent
n=7 Participants
Adolescent 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.
|
Sleep Promotion Program Parent
n=3 Participants
Parent 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.
|
|---|---|---|
|
Acceptability of Intervention Measure
|
3.75 Total Score
Standard Deviation 0.65
|
4.67 Total Score
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: Post-Intervention (~8 weeks)Population: Some participants did not complete this 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.
Outcome measures
| Measure |
Sleep Promotion Program Adolescent
n=6 Participants
Adolescent 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.
|
Sleep Promotion Program Parent
n=3 Participants
Parent 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.
|
|---|---|---|
|
Intervention Appropriateness Measure
|
4.29 Total Score
Standard Deviation 0.84
|
4.13 Total Score
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: Post-Intervention (~8 weeks)Population: Only youth complete this measure, however one youth participant did not have sufficient data on this measure.
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.
Outcome measures
| Measure |
Sleep Promotion Program Adolescent
n=7 Participants
Adolescent 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.
|
Sleep Promotion Program Parent
Parent 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.
|
|---|---|---|
|
Clinical Global Impressions Scale - Improvement
|
4.57 Total Score
Standard Deviation 1.99
|
—
|
PRIMARY outcome
Timeframe: Change Screening to Post-Intervention (~10 weeks)Population: Only youth provided data for this measure.
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.
Outcome measures
| Measure |
Sleep Promotion Program Adolescent
n=8 Participants
Adolescent 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.
|
Sleep Promotion Program Parent
Parent 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.
|
|---|---|---|
|
Patient Health Questionnaire - 9 - M
PHQ-9-M Change Score
|
-5.14 Change Score
Standard Deviation 5.10
|
—
|
|
Patient Health Questionnaire - 9 - M
PHQ-9-M Screening Score
|
14.38 Change Score
Standard Deviation 2.72
|
—
|
Adverse Events
Sleep Promotion Program Adolescent
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sleep Promotion Program Adolescent
n=8 participants at risk
Adolescent 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.
|
|---|---|
|
Psychiatric disorders
Suicidal ideation and/or passive death wish
|
37.5%
3/8 • Screening through Post-Intervention Follow-Up (typically about 12 weeks)
Parents were not systematically assessed for AEs.
|
Additional Information
Jessica Levenson
University of Pittsburgh School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place