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

NCT01315379 | Unknown

• 1 other identifier: 6166
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Traumatic Brain Injury; Post Concussive Syndrome

Keywords

Prolonged Exposure; CBT; PTSD; Mild Traumatic Brain Injury; Post Concussive Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change from Baseline in Neuropsychological Functioning at Treatment Completion

  After up to 18 weeks of treatment

• Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion

  At up to 18 weeks of PE treatment

• Change from Baseline in The Child PTSD Symptoms Scale at 2 weeks Follow Up

  2 weeks following treatment completion

• Change from Baseline in The Child PTSD Symptoms Scale at 4 weeks Follow Up

  4 weeks following treatment Completion

• Change from Baseline in The Child PTSD Symptoms Scale at 12 weeks Follow Up

  12 weeks following treatment completion

Study Arms (2)

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.

Behavioral: Prolonged Exposure Therapy

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.

Behavioral: Prolonged Exposure Therapy

Interventions

Prolonged Exposure Therapy 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; PTSD without TBI

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Maayans Shorer, PhD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maayan Shorer, PhD

CONTACT

++97239253864; maayans@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 15, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 11, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)