RECRUITING

Sleep Promotion Program Primary Care

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Sleep Promotion Program for Depressed Adolescents in Pediatric Primary Care

Quick Facts

Study Start:2024-12-13
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06240325

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able and willing to provide informed assent (with consent from parent/guardian)
  2. * Ages 12-18
  3. * Currently a patient at Kids Plus Pediatrics
  4. * Currently depressed
  5. * Report short sleep duration (\<7 hours on school nights) and/or weekday-weekend sleep timing difference of \>=2 hours
  1. * Significant or unstable medical conditions
  2. * Diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder
  3. * Diagnosis of PTSD, bipolar disorder, a psychotic disorder, or substance use disorder
  4. * Currently engaged in cognitive and/or behavioral therapy that aims to improve sleep
  5. * Changes in medications in the month prior to screening
  6. * Active suicidality requiring immediate treatment
  7. * Unable or unwilling to comply with study procedures
  8. * Have any physical or mental condition that would preclude study participation.
  9. * Express active suicidality that requires immediate treatment;
  10. * Have any physical or mental condition that would preclude study participation; OR
  11. * Are unable or unwilling to comply with study procedures.

Contacts and Locations

Study Contact

Jessica C Levenson
CONTACT
412-647-7937
levensonjc@upmc.edu
Paige DeGennaro
CONTACT
412-246-5974
degennaropl@upmc.edu

Principal Investigator

Jessica C Levenson
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15217
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Jessica C Levenson, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-13
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-12-13
Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

  • Sleep
  • Sleep Disturbance
  • Insufficient Sleep