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

NCT ID: NCT01315379

Last Updated: 2016-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2017-03-31

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.

Conditions

PTSD; Traumatic Brain Injury; Post Concussive Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Prolonged Exposure Therapy

Intervention Type: BEHAVIORAL

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.

Prolonged Exposure Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maayans Shorer, PhD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Maayan Shorer, PhD

Role: CONTACT

maayans@clalit.org.il

++97239253864

Facility Contacts

Maayans Shorer, PhD

Role: primary

maayans@clalit.org.il

++97239253864

Other Identifiers

6166

Identifier Type: -

Identifier Source: org_study_id