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

Sponsor

Rabin Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01315379

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PTSD Traumatic Brain Injury Post Concussive Syndrome	Behavioral: Prolonged Exposure Therapy

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

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.

Study Start Date :

Apr 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
PTSD without TBI 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 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 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.

Arm

Intervention/Treatment

PTSD without TBI

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

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

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

Outcome Measures

Primary Outcome Measures

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

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 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 4 weeks Follow Up [4 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 Childrens Depression Inventory at Treatment Completion [After up to 18 weeks of PE treatment]
Childrens Depression Inventory, Kovacs, 1992
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 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.
Change from Baseline in The Well-Being Questionnaire at Treatment Completion [After up to 18 weeks of PE treatment]
WHO-5 (Bech, 1998)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.