Stress Disorders, Post-TraumaticNCT00183326
Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence
A study testing Trauma-focused cognitive behavioral therapy (TF-CBT) and Child-centered supportive therapy (CCT) in people with Stress Disorders, Post-Traumatic and Anxiety, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
This study will determine whether trauma-focused cognitive behavioral therapy (TF-CBT) is more effective than child-centered therapy (CCT) in reducing post traumatic stress disorder (PTSD) in children exposed to domestic violence (DV). Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Anxiety, Depression
- What is being tested?
- Trauma-focused cognitive behavioral therapy (TF-CBT) and Child-centered supportive therapy (CCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Jul 2015
- Phase
- Interventional
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of PTSD related to exposure to DV, defined as their mother having been the victim of intimate partner violence within 1 year prior to study entry
- Able to read and understand English
- Parent or guardian able to read and understand English
- Parent or guardian willing to give informed consent
Who cannot join
- Certain psychiatric disorders which preclude participation in cognitive-based treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Center and Shelter of Greater Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Treating PTSD in Children Exposed to Domestic Violence
This study will determine whether trauma-focused cognitive behavioral therapy (TF-CBT) is more effective than child-centered therapy (CCT) in reducing post traumatic stress disorder (PTSD) in children exposed to domestic violence (DV).
Read the detailed description
Up to 10 million children in the United States are exposed to DV directed at their mothers by intimate partners. DV exposure puts these children at an increased risk for developing behavioral problems, depression, anxiety, and PTSD. While studies targeting PTSD in DV-exposed children are limited, data indicates that TF-CBT is effective in improving PTSD as well as depression, anxiety, and behavioral symptoms. This study will determine the effectiveness of TF-CBT in reducing PTSD and other DV-related psychological symptoms in children from a community DV agency in Pittsburgh, Pennsylvania.
This study will last 8 weeks. Children and their mothers will be randomly assigned to receive 8 weeks of either TF-CBT or CCT. In TF-CBT, patients recall the events of their trauma and try to deal with the emotions that arise. Supportive treatment empowers children to deal with their emotions in general. Both the children and their mothers will complete questionnaires at study entry and at Week 8. Children will also complete self-report scales at study entry and at Week 8. The questionnaires and self-report scales will be used to assess symptoms of PTSD, depression, anxiety, and behavioral problems. Children and their mothers will be contacted 6 and 12 months after study completion for follow-up interviews.
- Conditions
- Stress Disorders, Post-Traumatic, Anxiety, Depression
- Being tested
- Trauma-focused cognitive behavioral therapy (TF-CBT), Child-centered supportive therapy (CCT)
- Keywords
- Posttraumatic Stress Disorder, Domestic Violence, Children, Cognitive Behavioral Therapy, CBT
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-focused cognitive behavioral therapy (TF-CBT)Behavioural
TF-CBT is a psychotherapeutic intervention designed to help children, youth, and their parents overcome the negative effects of traumatic life events. It was developed by integrating cognitive and behavioral interventions with traditional child abuse therapies that focus on enhancement of interpersonal trust and empowerment. It targets PTSD symptoms, which often co-occur with depression and behavioral problems. TF-CBT also targets other issues experienced by those suffering a trauma including poor self-esteem, mood instability, and difficulty trusting others.
Child-centered supportive therapy (CCT)Behavioural
CCT demonstrates an empathic approach to healing. An environment consisting of empathy, unconditional positive regard and acceptance are key elements in this mode of therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive trauma-focused cognitive behavioral therapy Receives: Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT) |
| 2 | Active comparator | Participants will receive child-centered supportive therapy Receives: Behavioral: Child-centered supportive therapy (CCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms
Measured: Measured before and after treatment and Months 6 and 12 of follow-up
Anxiety
Measured: Measured before and after treatment and Months 6 and 12 of follow-up
Depression
Measured: Measured before and after treatment and Months 6 and 12 of follow-up
Behavior
Measured: Measured before and after treatment and Months 6 and 12 of follow-up
Secondary outcomes (1)
Contact with perpetrator
Measured: Measured at every treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionJul 2015
- Study completionJul 2015
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 Stress Disorders, Post-TraumaticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Judith Cohen, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Judith A. Cohen, MD, Principal investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183326
- Sponsor's protocol ID
- R01MH072590
- Other IDs
- R01MH072590, DDTR B3-PDS
- Status last verified
- Jul 2018
- First submitted
- 12 Sep 2005
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cohen JA, Mannarino AP, Iyengar S. Community treatment of posttraumatic stress disorder for children exposed to intimate partner violence: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Jan;165(1):16-21. doi: 10.1001/archpediatrics.2010.247.
PubMed 21199975
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating PTSD in Children Exposed to Domestic Violence
- ClinicalTrials.gov ID
- NCT00183326
- Acronym / sponsor ID
- R01MH072590
- Conditions
- Stress Disorders, Post-Traumatic, Anxiety, Depression
- Keywords
- Posttraumatic Stress Disorder, Domestic Violence, Children, Cognitive Behavioral Therapy, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2004
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Sep 2005 (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.
This study will determine whether trauma-focused cognitive behavioral therapy (TF-CBT) is more effective than child-centered therapy (CCT) in reducing post traumatic stress disorder (PTSD) in children exposed to domestic violence (DV).
Detailed description
Up to 10 million children in the United States are exposed to DV directed at their mothers by intimate partners. DV exposure puts these children at an increased risk for developing behavioral problems, depression, anxiety, and PTSD. While studies targeting PTSD in DV-exposed children are limited, data indicates that TF-CBT is effective in improving PTSD as well as depression, anxiety, and behavioral symptoms. This study will determine the effectiveness of TF-CBT in reducing PTSD and other DV-related psychological symptoms in children from a community DV agency in Pittsburgh, Pennsylvania.
This study will last 8 weeks. Children and their mothers will be randomly assigned to receive 8 weeks of either TF-CBT or CCT. In TF-CBT, patients recall the events of their trauma and try to deal with the emotions that arise. Supportive treatment empowers children to deal with their emotions in general. Both the children and their mothers will complete questionnaires at study entry and at Week 8. Children will also complete self-report scales at study entry and at Week 8. The questionnaires and self-report scales will be used to assess symptoms of PTSD, depression, anxiety, and behavioral problems. Children and their mothers will be contacted 6 and 12 months after study completion for follow-up interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)Participants will receive trauma-focused cognitive behavioral therapy |
| 2 | Active comparator | Behavioral: Child-centered supportive therapy (CCT)Participants will receive child-centered supportive therapy |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of PTSD related to exposure to DV, defined as their mother having been the victim of intimate partner violence within 1 year prior to study entry
- Able to read and understand English
- Parent or guardian able to read and understand English
- Parent or guardian willing to give informed consent
Key exclusion criteria (1 listed)
- Certain psychiatric disorders which preclude participation in cognitive-based treatment
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 |
|---|---|---|
| Trauma-focused cognitive behavioral therapy (TF-CBT)TF-CBT is a psychotherapeutic intervention designed to help children, youth, and their parents overcome the negative effects of traumatic life events. It was developed by integrating cognitive and behavioral interventions with traditional child abuse therapies that focus on enhancement of interpersonal trust and empowerment. It targets PTSD symptoms, which often co-occur with depression and behavioral problems. TF-CBT also targets other issues experienced by those suffering a trauma including poor self-esteem, mood instability, and difficulty trusting others. | Behavioural | 1 |
| Child-centered supportive therapy (CCT)CCT demonstrates an empathic approach to healing. An environment consisting of empathy, unconditional positive regard and acceptance are key elements in this mode of therapy. | Behavioural | 2 |
Primary outcome
PTSD symptoms
Time frame: Measured before and after treatment and Months 6 and 12 of follow-up
Anxiety
Time frame: Measured before and after treatment and Months 6 and 12 of follow-up
Depression
Time frame: Measured before and after treatment and Months 6 and 12 of follow-up
Behavior
Time frame: Measured before and after treatment and Months 6 and 12 of follow-up
1 secondary outcome
Contact with perpetrator
Time frame: Measured at every treatment session
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 5 Jul 2018.
- Background: PubMed 21199975Cohen JA, Mannarino AP, Iyengar S. Community treatment of posttraumatic stress disorder for children exposed to intimate partner violence: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Jan;165(1):16-21. doi: 10.1001/archpediatrics.2010.247.
- Click here to learn more about the National Child Traumatic Stress NetworkLink provided by the sponsor.
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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.
Judith A. Cohen, MD principal investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-focused cognitive behavioral therapy (TF-CBT) and Child-centered supportive therapy (CCT) in people with Stress Disorders, Post-Traumatic and Anxiety, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) 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 4 inclusion and 1 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 5 Jul 2018. 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.
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?
PTSD symptoms (time frame: Measured before and after treatment and Months 6 and 12 of follow-up). The study lists 4 primary outcomes in all. 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 NCT00183326, 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 5 Jul 2018.