RECRUITING

Get ActivE Study for At-risk Youth

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

The study will adapt and deploy a digital Behavioral Activation app with mobile sensing, supported by health coaches, that encourages youth to engage in positive activities. The study has the potential to offer a low-cost and scalable behavioral intervention that may decrease risk of suicide among at-risk youth. This research will examine specifically whether an intervention involving an app called Vira, combined with health coaching (GET ActivE) can improve enjoyment for teens coping with depression. Research participants will be randomly assigned to one of two study intervention. One study intervention involves a) downloading an app called Vira and engaging by responding to a daily question, and b) participating in a conversation via text, phone, or messages through an appt with a health coach. The health coach will use the Vira app and principles from evidence-based therapy and behavior change to provide users with insights to sustain well-being and better manage risk factors for suicidal thoughts and behaviors such as depressed mood and behavioral withdrawal. The second study intervention involves downloading an app called EARS and responding to a daily question.

Official Title

Geospatial and Ecological Momentary Assessment Technology and Activity Engagement for At-risk Youth (Get ActivE)

Quick Facts

Study Start:2025-03-27
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06829953

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. * Adolescents age 12-18
  2. * Current moderate to severe depression (PHQ-9-M \> 11)
  3. * Current clinically significant anhedonia, operationalized as PHQ-9-M anhedonia item score \> 1
  4. * English language fluency and literacy level sufficient to engage in study protocol
  5. * Willing to download the app on their smart phones
  1. * Evidence of mania, psychosis, or developmental disability precluding comprehension of study procedures per electronic health record review and phone screen.

Contacts and Locations

Study Contact

Brandie George-Milford, MA
CONTACT
412-246-5629
georgeba2@upmc.edu
Morgan Rose, BS
CONTACT
978-799-9419
rosem5@upmc.edu

Principal Investigator

Jamie Zelazny, PhD, MPH, RN
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Jamie Zelazny, PhD, MPH, RN, 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 Date2025-03-27
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-03-27
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Behavioral Activation
  • Health Coach
  • Anhedonia
  • Minority Youth
  • Suicide

Additional Relevant MeSH Terms

  • Anhedonia
  • Depression and Suicide Ideation