Prolonged Exposure Therapy (PE) for Post-traumatic Stress Symptoms and Mild TBI Symptoms in Children Following Motor Vehicle Accident.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PTSD
- Sponsor
- Rabin Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Percentage of participants with PTSD diagnosis as a measure of recovery rates
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For the whole sample:
- •Children age 6 to 18
- •Language spoken: Hebrew, Arabic
- •DSM- IV R diagnosis: PTSD
- •Car accident event within past 3 years
- •For the m-TBI group:
- •Any of the following symptoms or experiences occurring during or shortly after the accident: loss of consciousness, dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), visual loss, abdominal pain\].
- •Diagnosis of MTBI within 3 years as confirmed by CT/MRI/fMRI.
- •Glasgow coma scale; GCS\<15.
Exclusion Criteria
- •Children presenting with psychotic symptoms
- •Children presenting with mental retardation
Outcomes
Primary Outcomes
Percentage of participants with PTSD diagnosis as a measure of recovery rates
Time Frame: After up to 18 weeks of PE treatment
Psychological evaluation using the Hebrew translation of the Childhood version of the Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989).
Secondary Outcomes
- Change from Baseline in The Child PTSD Symptoms Scale at 4 weeks Follow Up(4 weeks following treatment Completion)
- Change from Baseline in Neuropsychological Functioning at Treatment Completion(After up to 18 weeks of treatment)
- Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion(At up to 18 weeks of PE treatment)
- Change from Baseline in the Children's Global Assessment Scale at Treatment Completion(After up to 18 weeks of PE treatment)
- Change from Baseline in The Well-Being Questionnaire at Treatment Completion(After up to 18 weeks of PE treatment)
- Change from Baseline in the Childrens Depression Inventory at Treatment Completion(After up to 18 weeks of PE treatment)
- Change from Baseline in The Child PTSD Symptoms Scale at 2 weeks Follow Up(2 weeks following treatment completion)
- Change from Baseline in The Child PTSD Symptoms Scale at 12 weeks Follow Up(12 weeks following treatment completion)
- Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion(After up to 18 weeks of PE Treatment)