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

Clalit Health Services

Status: Unknown

Conditions: Traumatic Brain Injury; PTSD; Post Concussive Syndrome

Treatments: Behavioral: Prolonged Exposure Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT01315379

6166

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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.

Exclusion criteria

• Children presenting with psychotic symptoms
• Children presenting with mental retardation

Trial design

60 participants in 2 patient groups

PTSD without TBI

Description:

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.

Treatment:

Behavioral: Prolonged Exposure Therapy

PTSD with m-TBI

Description:

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.

Treatment:

Behavioral: Prolonged Exposure Therapy