Brain Response to Treatment for Pediatric PTSD
Biomarkers of Clinical Response to Cognitive Treatment of PTSD in Youth
2 other identifiers
interventional
68
1 country
1
Brief Summary
This study will examine how brain activation changes as a result of behavioral treatment for posttraumatic stress disorder (PTSD) in adolescents. The investigators will conduct functional magnetic resonance imaging (fMRI) scans before and after the widely-used trauma-focused cognitive behavioral therapy to better understand how the brain recovers from illness. This study will provide much needed information about brain abnormalities in abused youth, and could lead to improvements in behavioral treatments for patients who do not respond to current treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedOctober 13, 2016
October 1, 2016
3.1 years
February 27, 2013
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
functional magnetic resonance imaging (brain activation)
We will use functional magnetic resonance imaging to measure changes in brain activation after 4 months of psychotherapy
change in brain activation after 4 months of treatment (baseline and 4 months)
Study Arms (1)
Psychotherapy
EXPERIMENTALTrauma-focused Cognitive Behavioral Therapy
Interventions
the 'gold-standard' behavioral treatment for children/adolescents with posttraumatic stress disorder
Eligibility Criteria
You may qualify if:
- ages 12-17, history of physical or sexual abuse, witnessing violence, or bullying; and English speaking
You may not qualify if:
- receiving other psychotherapy currently, taking medications for a psychiatric disorder currently, history of head injury with loss of consciousness longer than 5 minutes; major medical condition such as epilepsy, diabetes, heart disease, or loss of hearing or vision, developmental disorder such as fragile X, autism, or Down's Syndrome, MRI contraindications including metal in the body from an injury or surgery, non-removeable piercings, or braces, Intelligence Quotient (IQ) \< 70; schizophrenia, bipolar disorder, current substance abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Stanford University
Palo Alto, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy S Garrett, Ph.D.
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 27, 2013
First Posted
March 7, 2013
Study Start
April 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
October 13, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share