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

Prolonged Exposure Therapy (PE) for Post-traumatic Stress Symptoms and Mild TBI Symptoms in Children Following Motor Vehicle Accident.

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.

Study Overview

• Status: Unknown
• Conditions: PTSD; Traumatic Brain Injury; Post Concussive Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Maayan Shorer, PhD; Phone Number: ++97239253864; Email: maayans@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel
    • Recruiting
    • Schneider Children's Medical Center of Israel
    • Contact: Maayans Shorer, PhD; Phone Number: ++97239253864; Email: maayans@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Change from Baseline in the Childrens Depression Inventory at Treatment Completion	Childrens Depression Inventory, Kovacs, 1992	After up to 18 weeks of PE treatment
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	The State-Trait Anxiety Inventory for Children, Spielberger et al.	After up to 18 weeks of PE Treatment
Change from Baseline in The Well-Being Questionnaire at Treatment Completion	WHO-5 (Bech, 1998)	After up to 18 weeks of PE treatment

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Maayans Shorer, PhD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: March 3, 2011
• First Submitted That Met QC Criteria: March 13, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Estimate): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 9, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: PTSD; CBT; Prolonged Exposure; Mild Traumatic Brain Injury; Post Concussive Syndrome
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion
• Other Study ID Numbers: 6166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No