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Recruiting NCT06240325

Sleep Promotion Program Primary Care

No phase Interventional Sleep Sleep Disturbance Insufficient Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPP, Sleep Psychoeducation.
Who it may be relevant to
Registry conditions: Sleep, Sleep Disturbance, Insufficient Sleep. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care

Overview

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.

Interventions

  • Behavioral 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 t
  • Behavioral Sleep Psychoeducation
    Using the pamphlet also used in SPP, SPE will present sleep hygiene practices commonly included in sleep education programs and endorsed by national health organizations.

Primary outcome measures

  • Feasibility of Intervention Measure [Time frame: Post-Intervention (~8 weeks)]
  • Acceptability of Intervention Measure [Time frame: Post-Intervention (~8 weeks)]
  • Intervention Appropriateness Measure [Time frame: Post-Intervention (~8 weeks)]
  • Clinical Global Impressions Scale - Improvement [Time frame: Post-Intervention (~8 weeks)]
  • Patient Health Questionnaire - 9 - M [Time frame: Change Screening to Post-Intervention (~10 weeks)]
Secondary outcome measures (6)
  • Pediatric Sleep Survey Sleep Knowledge (SK) [Time frame: Training Start to End of Study Involvement (Up to 2.5 years)]
  • SPP Therapy Rating Scale [Time frame: Completed at each SPP Session (2 and 4 weeks after baseline)]
  • Sleep Diary Sleep Duration [Time frame: Baseline to Post-Intervention (~8 weeks)]
  • Sleep Diary Sleep-Wake Regularity [Time frame: Baseline to Post-Intervention (~8 weeks)]
  • Quick Inventory of Depressive Symptoms - Adolescent (17 item) - Self-Report (QIDS-A17-SR) [Time frame: Baseline to Post-Intervention (~8 weeks)]
  • Pediatric Sleep Survey PC [Time frame: Training Start to End of Study Involvement (up to 2.5 years)]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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 in the month prior to screening
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT06240325 · STUDY23010211 (RCT) · R34MH132724

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗