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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01315379
Other study ID # 6166
Secondary ID
Status Recruiting
Phase N/A
First received March 3, 2011
Last updated October 9, 2016
Start date April 2011
Est. completion date March 2017

Study information

Verified date October 2016
Source Rabin Medical Center
Contact Maayan Shorer, PhD
Phone ++97239253864
Email maayans@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 18 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective


Intervention

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.

Locations

Country Name City State
Israel Schneider Children's Medical Center of Israel Petach Tikva

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants with PTSD diagnosis as a measure of recovery rates Psychological evaluation using the Hebrew translation of the Childhood version of the Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989). After up to 18 weeks of PE treatment No
Secondary Change from Baseline in Neuropsychological Functioning at Treatment Completion 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
After up to 18 weeks of treatment No
Secondary Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion The Child PTSD Symptoms Scale (Foa et al., 2001) At up to 18 weeks of PE treatment No
Secondary Change from Baseline in The Child PTSD Symptoms Scale at 2 weeks Follow Up The Child PTSD Symptoms Scale (Foa et al., 2001) 2 weeks following treatment completion No
Secondary Change from Baseline in The Child PTSD Symptoms Scale at 4 weeks Follow Up The Child PTSD Symptoms Scale (Foa et al., 2001) 4 weeks following treatment Completion No
Secondary Change from Baseline in The Child PTSD Symptoms Scale at 12 weeks Follow Up The Child PTSD Symptoms Scale (Foa et al., 2001) 12 weeks following treatment completion No
Secondary Change from Baseline in the Childrens Depression Inventory at Treatment Completion Childrens Depression Inventory, Kovacs, 1992 After up to 18 weeks of PE treatment No
Secondary Change from Baseline in the Children's Global Assessment Scale at Treatment Completion After up to 18 weeks of PE treatment No
Secondary Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion The State-Trait Anxiety Inventory for Children, Spielberger et al. After up to 18 weeks of PE Treatment No
Secondary Change from Baseline in The Well-Being Questionnaire at Treatment Completion WHO-5 (Bech, 1998) After up to 18 weeks of PE treatment No
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