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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2011 by Rabin Medical Center
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01315379
First received: March 3, 2011
Last updated: March 13, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
PTSD
Mild Traumatic Brain Injury
Post Concussive Syndrome
Behavioral: Prolonged Exposure Therapy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prolonged Exposure Therapy (PE) for Post-traumatic Stress Symptoms and Mild TBI Symptoms in Children Following Motor Vehicle Accident.

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Percentage of participants with PTSD diagnosis as a measure of recovery rates [ Time Frame: After up to 18 weeks of PE treatment ] [ Designated as safety issue: No ]
    Psychological evaluation using the Hebrew translation of the Childhood version of the Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989).


Secondary Outcome Measures:
  • Change from Baseline in Neuropsychological Functioning at Treatment Completion [ Time Frame: After up to 18 weeks of treatment ] [ Designated as safety issue: No ]

    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


  • Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion [ Time Frame: At up to 18 weeks of PE treatment ] [ Designated as safety issue: No ]
    The Child PTSD Symptoms Scale (Foa et al., 2001)

  • Change from Baseline in The Child PTSD Symptoms Scale at 2 weeks Follow Up [ Time Frame: 2 weeks following treatment completion ] [ Designated as safety issue: No ]
    The Child PTSD Symptoms Scale (Foa et al., 2001)

  • Change from Baseline in The Child PTSD Symptoms Scale at 4 weeks Follow Up [ Time Frame: 4 weeks following treatment Completion ] [ Designated as safety issue: No ]
    The Child PTSD Symptoms Scale (Foa et al., 2001)

  • Change from Baseline in The Child PTSD Symptoms Scale at 12 weeks Follow Up [ Time Frame: 12 weeks following treatment completion ] [ Designated as safety issue: No ]
    The Child PTSD Symptoms Scale (Foa et al., 2001)

  • Change from Baseline in the Childrens Depression Inventory at Treatment Completion [ Time Frame: After up to 18 weeks of PE treatment ] [ Designated as safety issue: No ]
    Childrens Depression Inventory, Kovacs, 1992

  • Change from Baseline in the Children's Global Assessment Scale at Treatment Completion [ Time Frame: After up to 18 weeks of PE treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion [ Time Frame: After up to 18 weeks of PE Treatment ] [ Designated as safety issue: No ]
    The State-Trait Anxiety Inventory for Children, Spielberger et al.

  • Change from Baseline in The Well-Being Questionnaire at Treatment Completion [ Time Frame: After up to 18 weeks of PE treatment ] [ Designated as safety issue: No ]
    WHO-5 (Bech, 1998)


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PTSD without TBI 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 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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315379

Contacts
Contact: Maayan Shorer, PhD ++97239253864 maayans@clalit.org.il

Locations
Israel
Schneider Children's Medical Center of Israel Not yet recruiting
Petach Tikva, Israel
Contact: Maayans Shorer, PhD    ++97239253864    maayans@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Maayans Shorer, PhD Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01315379     History of Changes
Other Study ID Numbers: 6166
Study First Received: March 3, 2011
Last Updated: March 13, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Prolonged Exposure
CBT
PTSD
Mild Traumatic Brain Injury
Post Concussive Syndrome

Additional relevant MeSH terms:
Brain Concussion
Stress Disorders, Post-Traumatic
Brain Injuries
Post-Concussion Syndrome
Wounds and Injuries
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on August 27, 2014