Psychological Treatment for Children Suffering From Post Traumatic Stress Symptoms and Mild Traumatic Brain Injury (TBI)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
PTSD Mild Traumatic Brain Injury Post Concussive Syndrome |
Behavioral: Prolonged Exposure Therapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Prolonged Exposure Therapy (PE) for Post-traumatic Stress Symptoms and Mild TBI Symptoms in Children Following Motor Vehicle Accident. |
- Percentage of participants with PTSD diagnosis as a measure of recovery rates [ Time Frame: After up to 18 weeks of PE treatment ] [ Designated as safety issue: No ]Psychological evaluation using the Hebrew translation of the Childhood version of the Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989).
- Change from Baseline in Neuropsychological Functioning at Treatment Completion [ Time Frame: After up to 18 weeks of treatment ] [ Designated as safety issue: No ]
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
- Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion [ Time Frame: At up to 18 weeks of PE treatment ] [ Designated as safety issue: No ]The Child PTSD Symptoms Scale (Foa et al., 2001)
- Change from Baseline in The Child PTSD Symptoms Scale at 2 weeks Follow Up [ Time Frame: 2 weeks following treatment completion ] [ Designated as safety issue: No ]The Child PTSD Symptoms Scale (Foa et al., 2001)
- Change from Baseline in The Child PTSD Symptoms Scale at 4 weeks Follow Up [ Time Frame: 4 weeks following treatment Completion ] [ Designated as safety issue: No ]The Child PTSD Symptoms Scale (Foa et al., 2001)
- Change from Baseline in The Child PTSD Symptoms Scale at 12 weeks Follow Up [ Time Frame: 12 weeks following treatment completion ] [ Designated as safety issue: No ]The Child PTSD Symptoms Scale (Foa et al., 2001)
- Change from Baseline in the Childrens Depression Inventory at Treatment Completion [ Time Frame: After up to 18 weeks of PE treatment ] [ Designated as safety issue: No ]Childrens Depression Inventory, Kovacs, 1992
- Change from Baseline in the Children's Global Assessment Scale at Treatment Completion [ Time Frame: After up to 18 weeks of PE treatment ] [ Designated as safety issue: No ]
- Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion [ Time Frame: After up to 18 weeks of PE Treatment ] [ Designated as safety issue: No ]The State-Trait Anxiety Inventory for Children, Spielberger et al.
- Change from Baseline in The Well-Being Questionnaire at Treatment Completion [ Time Frame: After up to 18 weeks of PE treatment ] [ Designated as safety issue: No ]WHO-5 (Bech, 1998)
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| PTSD without TBI |
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.
|
| PTSD with m-TBI |
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.
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Sixty children age 6 to 18 attending the Anxiety clinic in Schneider Children's Medical Center of Israel, following MVA, will be included.
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
Contacts and Locations| Contact: Maayan Shorer, PhD | ++97239253864 | maayans@clalit.org.il |
| Israel | |
| Schneider Children's Medical Center of Israel | Not yet recruiting |
| Petach Tikva, Israel | |
| Contact: Maayans Shorer, PhD ++97239253864 maayans@clalit.org.il | |
| Principal Investigator: | Maayans Shorer, PhD | Rabin Medical Center |
More Information
No publications provided
| Responsible Party: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT01315379 History of Changes |
| Other Study ID Numbers: | 6166 |
| Study First Received: | March 3, 2011 |
| Last Updated: | March 13, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rabin Medical Center:
|
Prolonged Exposure CBT PTSD Mild Traumatic Brain Injury Post Concussive Syndrome |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Brain Injuries Post-Concussion Syndrome Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Brain Concussion Head Injuries, Closed Wounds, Nonpenetrating |
ClinicalTrials.gov processed this record on May 23, 2013