Clinical trial NCT01315379: Psychological Treatment for Children Suffering From Post Traumatic Stress Symptoms and Mild Traumatic Brain Injury
Official title: Prolonged Exposure Therapy (PE) for Post-traumatic Stress Symptoms and Mild TBI Symptoms in Children Following Motor Vehicle Accident.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PTSD
Traumatic Brain Injury
Post Concussive Syndrome
Keywords: Prolonged Exposure
CBT
PTSD
Mild Traumatic Brain Injury
Post Concussive Syndrome
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sixty children age 6 to 18 attending the Anxiety clinic in Schneider Children's Medical Center of Israel, following MVA, will be included.

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.

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

Primary outcomes:
measure: Percentage of participants with PTSD diagnosis as a measure of recovery rates
timeFrame: After up to 18 weeks of PE treatment
Secondary outcomes:
measure: Change from Baseline in Neuropsychological Functioning at Treatment Completion
timeFrame: After up to 18 weeks of treatment
measure: Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion
timeFrame: At up to 18 weeks of PE treatment
measure: Change from Baseline in The Child PTSD Symptoms Scale at 2 weeks Follow Up
timeFrame: 2 weeks following treatment completion
measure: Change from Baseline in The Child PTSD Symptoms Scale at 4 weeks Follow Up
timeFrame: 4 weeks following treatment Completion
measure: Change from Baseline in The Child PTSD Symptoms Scale at 12 weeks Follow Up
timeFrame: 12 weeks following treatment completion
measure: Change from Baseline in the Childrens Depression Inventory at Treatment Completion
timeFrame: After up to 18 weeks of PE treatment
measure: Change from Baseline in the Children's Global Assessment Scale at Treatment Completion
timeFrame: After up to 18 weeks of PE treatment
measure: Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion
timeFrame: After up to 18 weeks of PE Treatment
measure: Change from Baseline in The Well-Being Questionnaire at Treatment Completion
timeFrame: After up to 18 weeks of PE treatment
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Rabin Medical Center
name: Maayans Shorer, PhD
role: PRINCIPAL_INVESTIGATOR
References: