An observational study in PTSD, Traumatic Brain Injury and Post Concussive Syndrome, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-10-11.
Sponsored by Rabin Medical Center · Observational
The purpose of this study is to determine whether Prolonged Exposure Therapy (PE)is effective in the treatment of post-traumatic stress symptoms in children and adolescents with mild traumatic brain injury (m-TBI) due to motor vehicle accident.
Motor vehicle accidents account for a majority of TBI cases and are a leading cause for Post Traumatic Stress Disorder (PTSD) among children. The vast majority of these cases involve mild TBI (mTBI) with persistent post concussion syndromes. However, the empirical data on treatment in this field is scarce. Few studies demonstrated that cognitive behavioral therapies can be effective for adults with mild TBI suffering from Acute Stress Disorder, but no research, to date, addressed this question in pediatric population. In the current research we intend to examine the effectiveness of PE in reducing post-traumatic stress symptoms in children and adolescents with m-TBI caused by motor vehicle accident, in comparison to children and adolescents without brain injury.
Sixty children age 6 to 18 attending the Anxiety clinic in Schneider Children's Medical Center of Israel will be included. All subjects will be treated with a manualized 12-18 week Prolonged Exposure protocol. Participants will undergo assessments, which will include interviews, questionnaires and neuropsychological tests concerning symptoms of PTSD, emotional and cognitive functioning. Ratings and neuropsychological testing will be made at baseline and following completion of treatment. Follow up will include questionnaires ratings at 2 weeks, 4 weeks and 12 weeks after completion of treatment.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.
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Sixty children age 6 to 18 attending the Anxiety clinic in Schneider Children's Medical Center of Israel, following MVA, will be included.
For the whole sample:
For the m-TBI group:
Exclusion Criteria:
children and adolescents with a diagnosis of PTSD and without head injury, following a motor vehicle accident. This group will be treated using the Prolonged Exposure Therapy protocol.
Behavioral: Prolonged Exposure Therapy
children and adolescents with a diagnosis of PTSD and a diagnosis of mild traumatic brain injury, following a motor vehicle accident. This group will be treated using the Prolonged Exposure Therapy protocol.
Behavioral: Prolonged Exposure Therapy
This intervention comprises 12-18 sessions of cognitive behavior therapy for PTSD with the components (a) Psychological education, (b) in vivo exposure (c) prolonged imaginal exposure, (d) cognitive restructuring (e) summary and relapse prevention.
Percentage of participants with PTSD diagnosis as a measure of recovery rates
Psychological evaluation using the Hebrew translation of the Childhood version of the Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989).
Time frame: After up to 18 weeks of PE treatment
Change from Baseline in Neuropsychological Functioning at Treatment Completion
Subjects will take paper and pencil and computer tests to evaluate memory, learning, attention and concentration, vocabulary and naming. The neuropsychological testing battery includes: Raven's Progressive Matrices, BRIEF, WISC-III-Hebrew Version (Digit Span), CMS (Spatial Span), D-KEFS (Design Fluency, Sorting Test, Trails Making Test), CPT, Stroop,TOMM Effort validity test, The Connors Rating Scale- Revised Long version
Time frame: After up to 18 weeks of treatment
Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion
The Child PTSD Symptoms Scale (Foa et al., 2001)
Time frame: At up to 18 weeks of PE treatment
Change from Baseline in The Child PTSD Symptoms Scale at 2 weeks Follow Up
The Child PTSD Symptoms Scale (Foa et al., 2001)
Time frame: 2 weeks following treatment completion
Change from Baseline in The Child PTSD Symptoms Scale at 4 weeks Follow Up
The Child PTSD Symptoms Scale (Foa et al., 2001)
Time frame: 4 weeks following treatment Completion
Change from Baseline in The Child PTSD Symptoms Scale at 12 weeks Follow Up
The Child PTSD Symptoms Scale (Foa et al., 2001)
Time frame: 12 weeks following treatment completion
Change from Baseline in the Childrens Depression Inventory at Treatment Completion
Childrens Depression Inventory, Kovacs, 1992
Time frame: After up to 18 weeks of PE treatment
Change from Baseline in the Children's Global Assessment Scale at Treatment Completion
Time frame: After up to 18 weeks of PE treatment
Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion
The State-Trait Anxiety Inventory for Children, Spielberger et al.
Time frame: After up to 18 weeks of PE Treatment
Change from Baseline in The Well-Being Questionnaire at Treatment Completion
WHO-5 (Bech, 1998)
Time frame: After up to 18 weeks of PE treatment
Plan to share: No
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Rabin Medical Center