PTSDTBINCT01315379
Psychological Treatment for Children Suffering From Post Traumatic Stress Symptoms and Mild Traumatic Brain Injury
An observational study of PTSD and Traumatic Brain Injury, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- PTSD, Traumatic Brain Injury, Post Concussive Syndrome
- What is being tested?
- Prolonged Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- Children presenting with psychotic symptoms
- Children presenting with mental retardation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center of Israel
Petah Tikva
Maayans Shorer, PhD, ++97239253864, maayans@clalit.org.il
About this study
Official title: Prolonged Exposure Therapy (PE) for Post-traumatic Stress Symptoms and Mild TBI Symptoms in Children Following Motor Vehicle Accident.
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.
Read the 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.
- Conditions
- PTSD, Traumatic Brain Injury, Post Concussive Syndrome
- Being tested
- Prolonged Exposure Therapy
- Keywords
- Prolonged Exposure, CBT, PTSD, Mild Traumatic Brain Injury, Post Concussive Syndrome
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic, Post-Concussion Syndrome, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Prolonged Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After up to 18 weeks of PE treatment
Secondary outcomes (9)
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
Measured: After up to 18 weeks of treatment
Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion
The Child PTSD Symptoms Scale (Foa et al., 2001)
Measured: At up to 18 weeks of PE treatment
Change from Baseline in The Child PTSD Symptoms Scale at 2 weeks Follow Up
The Child PTSD Symptoms Scale (Foa et al., 2001)
Measured: 2 weeks following treatment completion
Change from Baseline in The Child PTSD Symptoms Scale at 4 weeks Follow Up
The Child PTSD Symptoms Scale (Foa et al., 2001)
Measured: 4 weeks following treatment Completion
Change from Baseline in The Child PTSD Symptoms Scale at 12 weeks Follow Up
The Child PTSD Symptoms Scale (Foa et al., 2001)
Measured: 12 weeks following treatment completion
Change from Baseline in the Childrens Depression Inventory at Treatment Completion
Childrens Depression Inventory, Kovacs, 1992
Measured: After up to 18 weeks of PE treatment
Change from Baseline in the Children's Global Assessment Scale at Treatment Completion
Measured: After up to 18 weeks of PE treatment
Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion
The State-Trait Anxiety Inventory for Children, Spielberger et al.
Measured: After up to 18 weeks of PE Treatment
Change from Baseline in The Well-Being Questionnaire at Treatment Completion
WHO-5 (Bech, 1998)
Measured: After up to 18 weeks of PE treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maayans Shorer, PhD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315379
- Sponsor's protocol ID
- 6166
- Acronym
- TBI
- Status last verified
- Oct 2016
- First submitted
- 3 Mar 2011
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Exposure Therapy (PE) for Post-traumatic Stress Symptoms and Mild TBI Symptoms in Children Following Motor Vehicle Accident.
- ClinicalTrials.gov ID
- NCT01315379
- Acronym / sponsor ID
- TBI / 6166
- Conditions
- PTSD, Traumatic Brain Injury, Post Concussive Syndrome
- Keywords
- Prolonged Exposure, CBT, PTSD, Mild Traumatic Brain Injury, Post Concussive Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD without TBI | – | Behavioral: Prolonged Exposure Therapychildren 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. |
| PTSD with m-TBI | – | Behavioral: Prolonged Exposure Therapychildren 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- Children age 6 to 18
- Language spoken: Hebrew, Arabic
- DSM- IV R diagnosis: PTSD
- Car accident event within past 3 years
- 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].
Key exclusion criteria (2 listed)
- Children presenting with psychotic symptoms
- Children presenting with mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure TherapyThis 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. | Behavioural | PTSD with m-TBI, PTSD without TBI |
Primary outcome
Percentage of participants with PTSD diagnosis as a measure of recovery rates
Time frame: After up to 18 weeks of PE treatment
Psychological evaluation using the Hebrew translation of the Childhood version of the Schedule for Affective Disorders and Schizophrenia (Apter et al., 1989).
9 secondary outcomes
Change from Baseline in Neuropsychological Functioning at Treatment Completion
Time frame: After up to 18 weeks of treatment
Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion
Time frame: At up to 18 weeks of PE treatment
Change from Baseline in The Child PTSD Symptoms Scale at 2 weeks Follow Up
Time frame: 2 weeks following treatment completion
Change from Baseline in The Child PTSD Symptoms Scale at 4 weeks Follow Up
Time frame: 4 weeks following treatment Completion
Change from Baseline in The Child PTSD Symptoms Scale at 12 weeks Follow Up
Time frame: 12 weeks following treatment completion
Change from Baseline in the Childrens Depression Inventory at Treatment Completion
Time frame: After up to 18 weeks of PE treatment
Change from Baseline in the Children's Global Assessment Scale at Treatment Completion
Time frame: After up to 18 weeks of PE treatment
Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion
Time frame: After up to 18 weeks of PE Treatment
Change from Baseline in The Well-Being Questionnaire at Treatment Completion
Time frame: After up to 18 weeks of PE treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maayans Shorer, PhD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Traumatic Brain Injury, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maayan Shorer, PhD (++97239253864, maayans@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with PTSD diagnosis as a measure of recovery rates (time frame: After up to 18 weeks of PE treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.