Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT04529031

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 11 - 15

Healthy Volunteers: Not accepted

Interventions

Reminder Focused Positive Psychiatry

attentional control condition (group process)

Study Details

Brief summary:

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.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT04529031

Start date

Apr 1, 2026

Status verified date

Mar, 2026

Completion date

Dec 28, 2028

Anticipated

Primary completion date

Dec 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 15

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Boy/Girl with documented PTSD,
  • aged 11- 15 years old,
  • able to read/write in English

Exclusion Criteria:

  • presence of intellectual disabilities,
  • presence of psychotic or self-injurious behavior,
  • presence of seizure disorder,
  • presence of language disorder,
  • presence of eye disorders,
  • presence of other neurodevelopmental disorders,
  • presence of diagnosis of substance use disorder.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: RFPP group intervention

The focus of RFPP is on enhancing contextual discrimination and emotional regulation, and promoting the use of adaptive coping strategies in response to trauma reminders, including recognizing reminders, shifting attention from intrusive memories during exposure to reminders to a focus on positive feelings, thoughts, goals, and choices.

sham comparator: attentional control condition (group process)

Subjects will receive progressive muscle relaxation and other relaxation techniques as well as education about PTSD and supportive psychotherapy. Parents will receive 4 sessions of relaxation techniques.

Interventions

Reminder Focused Positive Psychiatry

The focus of RFPP is on enhancing contextual discrimination and emotional regulation, and promoting the use of adaptive coping strategies in response to trauma reminders, including recognizing reminders, shifting attention from intrusive memories during exposure to reminders to a focus on positive feelings, thoughts, goals, and choices

attentional control condition (group process)

This group process will undergo telehealth relaxation therapy twice a week for 6-week. Subjects will receive progressive muscle relaxation and other relaxation techniques as well as education about PTSD and supportive psychotherapy

Primary outcome measure

  • To examine the impact of RFPP intervention on core PTSD symptoms [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Naser Ahmadi, MD PhD

424 298 8846ahmadi@ucla.edu

Naser Ahmadi, MD PhD

4242988846nahmadi@mednet.ucla.edu

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90024

Contacts

Naser Ahmadi, MD

4244420585nahmadi@mednet.ucla.edu

Principal Investigator:

Naser Ahmadi, MD PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-03-27.