SPP / Insufficient Sleep / Sleep · Interventional Study

Sleep Promotion Program Primary Care

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a recruitment-phase pilot RCT registration comparing a brief behavioral Sleep Promotion Program (SPP) to Sleep Psychoeducation in adolescents with short sleep duration and sleep-wake irregularity. No results are posted in this registry record. The study is designed to assess feasibility, acceptability, and initial effectiveness; findings, when available, will be preliminary and hypothesis-generating rather than definitive.

What was studied

Interventional, Randomized, Parallel, Single masking, Treatment purpose. Sleep, Sleep Disturbance, Insufficient Sleep; age from 12 Years; to 18 Years. Intervention: Sleep Promotion Program. Compared with: Sleep Psychoeducation — Active Comparator. n = 100. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

No clinical impact can be assessed from this registry record, as no results are posted. Readers should await completion and publication of trial results before interpreting efficacy or safety.

Plain-language summary

This is a recruitment-phase registry record for a pilot RCT with no results posted; feasibility and acceptability outcomes are planned but not yet reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Feasibility of Intervention Measure (assessed at Post-Intervention (~8 weeks)); Acceptability of Intervention Measure (assessed at Post-Intervention (~8 weeks)); Intervention Appropriateness Measure (assessed at Post-Intervention (~8 weeks)); Clinical Global Impressions Scale - Improvement (assessed at Post-Intervention (~8 weeks)); Patient Health Questionnaire - 9 - M (assessed at Change Screening to Post-Intervention (~10 weeks))

DesignInterventional, Randomized, Parallel, Single masking, Treatment purpose

PopulationSleep, Sleep Disturbance, Insufficient Sleep; age from 12 Years; to 18 Years

Sample size100

InterventionSleep Promotion Program

ComparatorSleep Psychoeducation — Active Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Estimated sample size50

Total enrollment target100

Age range12–18 years

Follow-up duration (primary outcomes)~8 weeks post-intervention

Primary outcome: Feasibility of Intervention MeasurePost-Intervention (~8 weeks)

Primary outcome: Acceptability of Intervention MeasurePost-Intervention (~8 weeks)

Primary outcome: Intervention Appropriateness MeasurePost-Intervention (~8 weeks)

Primary outcome: Clinical Global Impressions Scale - ImprovementPost-Intervention (~8 weeks)

Clinical bottom line

No clinical impact can be assessed from this registry record, as no results are posted. Readers should await completion and publication of trial results before interpreting efficacy or safety.

Caveats

This is a registry record only; no results are reported and study is still recruiting.
Blinding strategy and randomization methods not described.
Study is powered for feasibility and acceptability, not efficacy; effect sizes will not be reported with statistical power.
Follow-up duration (~8–10 weeks) is short; longer-term outcomes not assessed.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Pilot randomized controlled trial design with active comparator; phase and blinding status not stated.

Directness

strong

Targets adolescents aged 12–18 with sleep disturbance and depression; direct clinical population.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Randomization and blinding methods not described in registry; risk of bias assessment premature.

Sample adequacy

limited

Pilot study with estimated n=50 randomized; adequate for feasibility, underpowered for efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06240325). This is a study registration, not published results. Lead sponsor: University of Pittsburgh. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Sleep, Sleep Disturbance, Insufficient Sleep. Interventions: BEHAVIORAL: SPP; BEHAVIORAL: Sleep Psychoeducation. Primary outcome measures: Feasibility of Intervention Measure , Post-Intervention (~8 weeks); Acceptability of Intervention Measure , Post-Intervention (~8 weeks); Intervention Appropriateness Measure , Post-Intervention (~8 weeks); Clinical Global Impressions Scale - Improvement , Post-Intervention (~8 weeks); Patient Health Questionnaire - 9 - M , Change Screening to Post-Intervention (~10 weeks). Brief summary: Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on two individual sessions and smart phone technology to deliver evidence-based strategies. This R34 will test the feasibility and initial effectiveness of the SPP program and provider training via pilot randomized controlled trial (RCT, n=50) comparing SPP to Sleep Psychoeducation, a brief session on healthy sleep habits. Participants will be adolescents (12-18 years) with short sleep duration, sleep-wake irregularity, and depression.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

SPPNCT06240325University of PittsburghInsufficient SleepSleepSleep DisturbanceSleep Psychoeducation