Sleep Promotion Program Primary Care (SPP PC)

University of Pittsburgh

Status: Enrolling

Conditions: Insufficient Sleep; Sleep Disturbance; Sleep

Treatments: Behavioral: SPP; Behavioral: Sleep Psychoeducation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06240325

R34MH132724 (U.S. NIH Grant/Contract)

STUDY23010211 (RCT)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Sleep Promotion Program

Experimental group

Description:

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.

Treatment:

Behavioral: SPP

Sleep Psychoeducation

Active Comparator group

Description:

Participants will receive Sleep Psychoeducation (SPE), a 20-minute discussion with a clinician via telehealth (or in person).

Treatment:

Behavioral: Sleep Psychoeducation