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

Traumatic Brain Injury Clinical Trial

— TBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315379
• Other study ID #: 6166
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2011
• Last updated: October 9, 2016
• Start date: April 2011
• Est. completion date: March 2017

Study information

• Verified date: October 2016
• Source: Rabin Medical Center
• Contact: Maayan Shorer, PhD
• Phone: ++97239253864
• Email: maayans[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Post Concussive Syndrome
• Post-Concussion Syndrome
• PTSD
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
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	No
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	No
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	No
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	No
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	No
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	No
Secondary	Change from Baseline in the Children's Global Assessment Scale at Treatment Completion		After up to 18 weeks of PE treatment	No
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	No
Secondary	Change from Baseline in The Well-Being Questionnaire at Treatment Completion	WHO-5 (Bech, 1998)	After up to 18 weeks of PE treatment	No