Have you or your loved ones been diagnosed with post-concussion syndrome?

You may be eligible to participate in a post-concussion syndrome clinical trial.

Have you or your loved ones been diagnosed with post-concussion syndrome? You may be eligible to participate in a post-concussion syndrome clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Post-Concussion Syndrome Clinical Trial in Petach Tikva

NCT01315379 | Observational

Have you or your loved ones been diagnosed with post-concussion syndrome?

You may be eligible to participate in a post-concussion syndrome clinical trial.

Have you or your loved ones been diagnosed with post-concussion syndrome? You may be eligible to participate in a post-concussion syndrome clinical trial.

Recruiting

Male & Female

6 - 18

Years old

This study is looking to recruit 60 Participants

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.

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Details for the 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.

Brief Title

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

Official Title

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

Brief Summary

The purpose of this study is to determine whether Prolonged Exposure Therapy (PE)is effective<br /> in the treatment of post-traumatic stress symptoms in children and adolescents with mild<br /> 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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Secondary

Change from Baseline in The Well-Being Questionnaire at Treatment Completion

WHO-5 (Bech, 1998)

After up to 18 weeks of PE treatment

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

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

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

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

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

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

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

Study 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