Sleep Promotion Program Primary Care (SPP PC) Open Trial (SPP OT)

University of Pittsburgh

Status: Enrolling

Conditions: Insufficient Sleep; Sleep Disturbance; Sleep

Treatments: Behavioral: Sleep Promotion Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06239792

STUDY23010211 (Open)

R34MH132724 (U.S. NIH Grant/Contract)

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 one individual session and smart phone technology to deliver evidence-based strategies. This open trial portion of the R34 will focus on conducting an open trial (n=8) to iteratively refine provider training, implementation procedures, and SPP program, per participant and staff feedback.

Enrollment: 16 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

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: Sleep Promotion Program