Psychological Treatment for Children Suffering From Post Traumatic Stress Symptoms and Mild Traumatic Brain Injury

• Conditions: PTSD; Traumatic Brain Injury; Post Concussive Syndrome
• Interventions: Behavioral: Prolonged Exposure Therapy

• Registration Number: NCT01315379
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-13
• Study First Posted: 2011-03-15
• Study Start: 2011-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-09
• Last Update Posted: 2016-10-11
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PTSD without TBI	Prolonged Exposure Therapy	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.
PTSD with m-TBI	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.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with PTSD diagnosis as a measure of recovery rates	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 Outcome Measures

Name	Time	Method
Change from Baseline in The Child PTSD Symptoms Scale at 4 weeks Follow Up	4 weeks following treatment Completion	The Child PTSD Symptoms Scale (Foa et al., 2001)
Change from Baseline in Neuropsychological Functioning at Treatment Completion	After up to 18 weeks of treatment	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	At up to 18 weeks of PE treatment	The Child PTSD Symptoms Scale (Foa et al., 2001)
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	WHO-5 (Bech, 1998)
Change from Baseline in the Childrens Depression Inventory at Treatment Completion	After up to 18 weeks of PE treatment	Childrens Depression Inventory, Kovacs, 1992
Change from Baseline in The Child PTSD Symptoms Scale at 2 weeks Follow Up	2 weeks following treatment completion	The Child PTSD Symptoms Scale (Foa et al., 2001)
Change from Baseline in The Child PTSD Symptoms Scale at 12 weeks Follow Up	12 weeks following treatment completion	The Child PTSD Symptoms Scale (Foa et al., 2001)
Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion	After up to 18 weeks of PE Treatment	The State-Trait Anxiety Inventory for Children, Spielberger et al.

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikva, Israel