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

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University of Pittsburgh

Status

Not yet 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)

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

Trial contacts and locations

0

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Central trial contact

Paige DeGennaro; Jessica C Levenson

Data sourced from clinicaltrials.gov

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