Clinical trial NCT04529031: Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry
Official title: Clinical and Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry in Adolescent With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To examine the impact of RFPP intervention on core PTSD symptoms
timeFrame: 24 months
Secondary outcomes:
measure: To assess the impact of RFPP on well-being of adolescents with PTSD and their parents
timeFrame: 24 months
measure: To examine the impact of RFPP on biologic biomarkers, compared to control group
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References: