RECRUITING

Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry

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

Objective: Posttraumatic stress disorder (PTSD) is a prevalent neuropsychiatric disorder in children and is associated with increased neurovascular inflammation, suicidality, adulthood mental health disorder, and major adverse events. Reminder focused positive psychiatry (RFPP) has been shown as well tolerated feasible trauma focused intervention that is associated with improved core PTSD symptoms, decreased severity of reactivity to PTSD trauma reminders, and increased vascular function. This study evaluates the clinical and biomolecular characteristics of RFPP in adolescents with PTSD. Research Design/Overall Impact: After obtaining parents' informed consent and adolescent's assent, 60 adolescents aged 11-15 years old with PTSD, and free of known medical and other major psychiatric disorders will be recruited from the pool of eligible adolescents at Olive View UCLA Pediatrics Clinics (\>3000 adolescents with PTSD). Eligible adolescents will be randomized to 1) RFPP group intervention, or 2) an attentional control condition (group process). Thirty subjects in each group will receive twice weekly telehealth intervention of either RFPP or group process, for 6 weeks, and undergo 4 blinded neuropsychiatric assessments at baseline, 3, 6, and 24 weeks. Parents will receive weekly interventions of either positive psychoeducation or group process, for 6 weeks and undergo baseline, 3, 6- and 24-weeks neuropsychiatric assessment. Vascular function, inflammatory biomarkers including CRP, homocysteine, and stress involved gene expression biomarkers (i.e. changes in gene expression of FKBP5, DDX6, B2M, LAIR1, RTN4, NUB1, and a multi-gene Conserved Transcriptional Response to Adversity score (CTRA) will be measured at baseline and 6-week. The primary and secondary endpoints are a) changes in PTSD core and reactivity to trauma reminder severity score in response to RFPP intervention, b) changes in wellbeing, biopsychosocial trait, vascular function, neuroinflammation and gene expression biomarkers in response to RFPP, and c) changes in parents' wellbeing and biopsychosocial trait as well as child-parent interactions.

Official Title

Clinical and Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry in Adolescent With Posttraumatic Stress Disorder

Quick Facts

Study Start:2024-09-01
Study Completion:2026-12-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04529031

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:11 Years to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Boy/Girl with documented PTSD,
  2. * aged 11- 15 years old,
  3. * able to read/write in English
  1. * presence of intellectual disabilities,
  2. * presence of psychotic or self-injurious behavior,
  3. * presence of seizure disorder,
  4. * presence of language disorder,
  5. * presence of eye disorders,
  6. * presence of other neurodevelopmental disorders,
  7. * presence of diagnosis of substance use disorder.

Contacts and Locations

Study Contact

Naser Ahmadi, MD PhD
CONTACT
424 298 8846
ahmadi@ucla.edu
Naser Ahmadi, MD PhD
CONTACT
4242988846
nahmadi@mednet.ucla.edu

Study Locations (Sites)

UCLA
Los Angeles, California, 90024
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

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 Date2024-09-01
Study Completion Date2026-12-28

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2026-12-28

Terms related to this study

Additional Relevant MeSH Terms

  • Posttraumatic Stress Disorder