Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04529031
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2020-08-20
Brief Title:
Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Clinical and Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry in Adolescent With Posttraumatic Stress Disorder
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RFPP
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 DesignOverall Impact After obtaining parents informed consent and adolescents 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 ie 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
Research DesignOverall Impact After obtaining parents informed consent and adolescents 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None