RECRUITING

Positive Affect Treatment for Adolescents with Early Life Adversity

Conditions

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

Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For the initial pilot phase of the investigation, the investigators will recruit up to 30 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. For the second phase of the investigation, the investigators will recruit up to 300 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or supportive psychotherapy. For both phases, at study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia and reward sensitivity). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth.

Official Title

Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy

Quick Facts

Study Start:2024-02-03
Study Completion:2030-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06273137

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 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * aged 12-16
  2. * exposed to 2 or more adverse childhood experiences (ACEs)
  1. * currently taking an antidepressant or any medications known to influence immune functioning on a daily basis (e.g., steroidal medications to treat asthma or allergies)
  2. * current or past history of manic or psychotic symptoms
  3. * parent-reported diagnosis of intellectual disability or autism spectrum disorder
  4. * chronic medical conditions (e.g., cancer, rheumatoid arthritis, diabetes, multiple sclerosis),
  5. * bleeding disorders such as hemophilia

Contacts and Locations

Study Contact

Kate R Kuhlman, Ph.D.
CONTACT
9498245574
krkuhl@uci.edu

Principal Investigator

Kate R Kuhlman
PRINCIPAL_INVESTIGATOR
UC Irvine

Study Locations (Sites)

University of California Irvine
Irvine, California, 92617
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Kate R Kuhlman, PRINCIPAL_INVESTIGATOR, UC Irvine

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 Date2024-02-03
Study Completion Date2030-10-31

Study Record Updates

Study Start Date2024-02-03
Study Completion Date2030-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Depression