Clinical trial NCT06240325: Sleep Promotion Program Primary Care
Official title: A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Sleep Disturbance
Insufficient Sleep
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Feasibility of Intervention Measure
timeFrame: Post-Intervention (~8 weeks)
measure: Acceptability of Intervention Measure
timeFrame: Post-Intervention (~8 weeks)
measure: Intervention Appropriateness Measure
timeFrame: Post-Intervention (~8 weeks)
measure: Clinical Global Impressions Scale - Improvement
timeFrame: Post-Intervention (~8 weeks)
measure: Patient Health Questionnaire - 9 - M
timeFrame: Change Screening to Post-Intervention (~10 weeks)
Secondary outcomes:
measure: Pediatric Sleep Survey Sleep Knowledge (SK)
timeFrame: Training Start to End of Study Involvement (Up to 2.5 years)
measure: SPP Therapy Rating Scale
timeFrame: Completed at each SPP Session (2 and 4 weeks after baseline)
measure: Sleep Diary Sleep Duration
timeFrame: Baseline to Post-Intervention (~8 weeks)
measure: Sleep Diary Sleep-Wake Regularity
timeFrame: Baseline to Post-Intervention (~8 weeks)
measure: Quick Inventory of Depressive Symptoms - Adolescent (17 item) - Self-Report (QIDS-A17-SR)
timeFrame: Baseline to Post-Intervention (~8 weeks)
measure: Pediatric Sleep Survey PC
timeFrame: Training Start to End of Study Involvement (up to 2.5 years)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jessica C Levenson
role: PRINCIPAL_INVESTIGATOR
References: