Posttraumatic Stress DisorderPhase 1/2CFTSINCT01031615
Evaluation of the Child and Family Traumatic Stress Intervention
A Phase 1/2 study testing Child and Family Traumatic Stress Interv (CFTSI) and Psychoeducational Comparison in people with Posttraumatic Stress Disorder, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of the Child and Family Traumatic Stress Intervention (CFTSI) in preventing the development of Posttraumatic Stress Disorder (PTSD) when implemented within 30 days of a potentially traumatic event. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Child and Family Traumatic Stress Interv (CFTSI) and Psychoeducational Comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Sep 2009
- Phase
- Phase 1/2
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth exposed to a potentially traumatic event within the last 30 days who have one new symptom on the Posttraumatic Checklist (PCL)
Who cannot join
- Already receiving mental health treatment
- Autism or Developmental Disability
- Diagnosed with psychosis or bipolar disorder
- Non-english speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University Child Study Center
New Haven, Connecticut, 06520
About this study
The purpose of this study is to determine the efficacy of the Child and Family Traumatic Stress Intervention (CFTSI) in preventing the development of Posttraumatic Stress Disorder (PTSD) when implemented within 30 days of a potentially traumatic event.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Child and Family Traumatic Stress Interv (CFTSI), Psychoeducational Comparison
- Keywords
- School age children and adolescents exposed to a potentially traumatic event
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child and Family Traumatic Stress Interv (CFTSI)Behavioural
4 sessions involving both the target child and a parent/caregiver
Psychoeducational ComparisonBehavioural
4 individually focused sessions including psychoeducation and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Child and Family Traumatic Stress Interv | Experimental | 4-session secondary prevention model that focuses on family communication about symptoms of a child aged 7-16. Receives: Behavioral: Child and Family Traumatic Stress Interv (CFTSI) |
| Psychoeducational Comparison | Active comparator | 4-sessions focused on individual child using psychoeducation and relaxation skills Receives: Behavioral: Psychoeducational Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Posttraumatic Reaction Index (PTSD-RI)
Measured: 3 months post-intervention
Secondary outcomes (1)
Trauma Symptom Checklist for Children (TSCC)
Measured: 3 Months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startOct 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Steven Berkowitz, M.D., Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031615
- Sponsor's protocol ID
- 0504027679
- Other IDs
- SAMHSA U79SM54318
- Acronym
- CFTSI
- Status last verified
- Jun 2011
- First submitted
- 10 Dec 2009
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Berkowitz SJ, Stover CS, Marans SR. The Child and Family Traumatic Stress Intervention: secondary prevention for youth at risk of developing PTSD. J Child Psychol Psychiatry. 2011 Jun;52(6):676-85. doi: 10.1111/j.1469-7610.2010.02321.x. Epub 2010 Sep 24.
PubMed 20868370
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Child and Family Traumatic Stress Intervention
- ClinicalTrials.gov ID
- NCT01031615
- Acronym / sponsor ID
- CFTSI / 0504027679
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- School age children and adolescents exposed to a potentially traumatic event
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Dec 2009 (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 the efficacy of the Child and Family Traumatic Stress Intervention (CFTSI) in preventing the development of Posttraumatic Stress Disorder (PTSD) when implemented within 30 days of a potentially traumatic event.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child and Family Traumatic Stress Interv | Experimental | Behavioral: Child and Family Traumatic Stress Interv (CFTSI)4-session secondary prevention model that focuses on family communication about symptoms of a child aged 7-16. |
| Psychoeducational Comparison | Active comparator | Behavioral: Psychoeducational Comparison4-sessions focused on individual child using psychoeducation and relaxation skills |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Youth exposed to a potentially traumatic event within the last 30 days who have one new symptom on the Posttraumatic Checklist (PCL)
Key exclusion criteria (4 listed)
- Already receiving mental health treatment
- Autism or Developmental Disability
- Diagnosed with psychosis or bipolar disorder
- Non-english speaking
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 |
|---|---|---|
| Child and Family Traumatic Stress Interv (CFTSI)4 sessions involving both the target child and a parent/caregiver | Behavioural | Child and Family Traumatic Stress Interv |
| Psychoeducational Comparison4 individually focused sessions including psychoeducation and relaxation. | Behavioural | Psychoeducational Comparison |
Primary outcome
UCLA Posttraumatic Reaction Index (PTSD-RI)
Time frame: 3 months post-intervention
1 secondary outcome
Trauma Symptom Checklist for Children (TSCC)
Time frame: 3 Months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
- Background: PubMed 20868370Berkowitz SJ, Stover CS, Marans SR. The Child and Family Traumatic Stress Intervention: secondary prevention for youth at risk of developing PTSD. J Child Psychol Psychiatry. 2011 Jun;52(6):676-85. doi: 10.1111/j.1469-7610.2010.02321.x. Epub 2010 Sep 24.
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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.
Steven Berkowitz, M.D. study director
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Child and Family Traumatic Stress Interv (CFTSI) and Psychoeducational Comparison in people with Posttraumatic Stress Disorder, run by Yale University at 1 site in United States.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jun 2011. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA Posttraumatic Reaction Index (PTSD-RI) (time frame: 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01031615, which also lists 1 linked publication.
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 16 Jun 2011.