Child AbusePhase 1PFFNCT00494286
Abuse-Focused Cognitive Behavioral Therapy for Children Who Have Been Physically Abused
A Phase 1 study testing Abused-focused cognitive behavioral therapy (AF-CBT) and Treatment as usual (TAU) in people with Child Abuse, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will determine the effectiveness of abuse-focused cognitive behavioral therapy that is provided by a community health clinic in addressing the behavioral and emotional health needs of children and adolescents whose parents have used physical disciplinary action. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Child Abuse
- What is being tested?
- Abused-focused cognitive behavioral therapy (AF-CBT) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2012
- Phase
- Phase 1
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is between 5 and 15 years of age
- Any one of the following child discipline criteria are met within the past 12 months:
- the parent reports that the child has been the target of physical force/contact (e.g. discipline, punishment),
- the parent reports that the child has been the target of other acts that place the child at-risk for physical harm/injury (including threats of injury or harm) or
- an allegation or report of suspected physical abuse of this child was made to child welfare regardless of the outcome;
- Child and caregiver (preferably, not necessarily, the offending or at-risk caregiver, and regardless of whether they live together currently), will participate in services, and should be able to make progress in the proposed agency services;
- Parent/legal guardian must agree to informed consent for child and there is no immediate plan for a change in parental rights (e.g., child going to pre-adoptive foster care).
Who cannot join
- Child or parent is identified by agency staff as exhibiting serious psychological or intellectual impairment that would prevent minimal participation or progress in treatment (e.g., severe drug dependence, active psychosis, or pervasive developmental disorder)
- Child is in placement without access to a legal guardian who can provide informed consent OR a change in parental rights is likely to occur in the near future
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Child Physical Abuse: An Effectiveness Trial (PFF)
This study will determine the effectiveness of abuse-focused cognitive behavioral therapy that is provided by a community health clinic in addressing the behavioral and emotional health needs of children and adolescents whose parents have used physical disciplinary action.
Read the detailed description
Child physical abuse is a common public health problem that has been associated with significant psychosocial and physical health problems among children. Abuse-focused cognitive-behavioral therapy (AF-CBT) has been identified as an effective treatment strategy for dealing with child physical abuse. The main component of AF-CBT, cognitive behavioral therapy (CBT), is a type of psychotherapy in which everyday thoughts and behaviors are modified to improve mental health problems, such as depression or anxiety. AF-CBT uses CBT techniques to specifically focus on improving the mental health problems associated with physical abuse. In this study, AF-CBT will incorporate individual and family CBT and will be adapted by community practitioners to maximize its effectiveness in a community health care setting. This study will determine the effectiveness of AF-CBT, provided by a community health clinic, in addressing the behavioral and emotional health needs of children and adolescents whose parents have used physical disciplinary action.
Participants in this study will include practitioners, their supervisors, and their patients. Practitioners will be randomly assigned to provide either treatment as usual (TAU) or the AF-CBT intervention for 3 to 6 months. Patient participants will continue to see their regular practitioner, but will receive the type of treatment to which their practitioner has been assigned. Practitioners who are assigned to TAU will continue to attend training workshops or seminars as a part of their clinics' routine policies and their current personal practices. Practitioners who are assigned to AF-CBT will first receive training in the treatment method. The training curriculum will include a published treatment book, intensive training sessions, which will occur weekly for 8 hours over 4 weeks, handouts that illustrate key therapeutic information and exercises, and ongoing case consultation reviews for 5 months.
Parent and child participants will meet with practitioners at times to be decided based on individual patient needs. All parents and children will be asked to participate in interviews to assess symptoms and outcomes before attending any treatment sessions with the practitioner, 6 months, 12 months, 18 months,and 30 months after baseline. Parents and children will also complete questionnaires each time they meet with the practitioner. This study will also assess the ability of the practitioners and supervisors to carry out AF-CBT.
- Conditions
- Child Abuse
- Being tested
- Abused-focused cognitive behavioral therapy (AF-CBT), Treatment as usual (TAU)
- Keywords
- Abuse Focused Cognitive Behavioral Therapy, Treatment Effectiveness Research, Treatment Dissemination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abused-focused cognitive behavioral therapy (AF-CBT)Behavioural
Practitioners will be randomly assigned to provide the AF-CBT treatment for 3 to 6 months. Patient participants will continue to see their regular practitioner, but will receive AF-CBT at treatment visits. Practitioners who are assigned to AF-CBT will first receive training in the treatment method. The training curriculum will include a published treatment book, intensive training sessions, which will occur weekly for 8 hours over 4 weeks, handouts that illustrate key therapeutic information and exercises, and ongoing case consultation reviews for 5 months.
Treatment as usual (TAU)Behavioural
This condition consists of those practitioners in each agency who will not receive study training in AF-CBT. These practitioners will simply provide services as available within their agencies.
| Study group | Role | What they receive |
|---|---|---|
| AF-CBT | Experimental | Participants will receive abused-focused cognitive behavioral therapy Receives: Behavioral: Abused-focused cognitive behavioral therapy (AF-CBT) |
| TAU | Active comparator | Participants will receive treatment as usual Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family outcomes, including client engagement in service
Measured: Measured at baseline and Months 6, 12, 18, 24, and 30
Mental health functioning (symptom improvement, family support, more appropriate parenting practices) and outside service use (social service system contact or child placement/disruption)
Measured: Measured at baseline and Months 6, 12, 18, 24, and 30
Child welfare status (recidivism or re-injury rates)
Measured: Measured at baseline and Months 6, 12, 18, 24, and 30
Secondary outcomes (2)
Practitioner knowledge about treatment
Measured: Measured at baseline and Months 6, 12, 18, 24, and 30
Practitioner competency and patient's satisfaction with treatment
Measured: Measured at baseline and Months 6, 12, 18, 24, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startSep 2006
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Kolko, University of Pittsburgh
- Investigators
- David J. Kolko, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494286
- Sponsor's protocol ID
- R01MH074737
- Other IDs
- R01MH074737, DSIR CT-C
- Acronym
- PFF
- Status last verified
- Feb 2013
- First submitted
- 27 Jun 2007
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Child Physical Abuse: An Effectiveness Trial (PFF)
- ClinicalTrials.gov ID
- NCT00494286
- Acronym / sponsor ID
- PFF / R01MH074737
- Conditions
- Child Abuse
- Keywords
- Abuse Focused Cognitive Behavioral Therapy, Treatment Effectiveness Research, Treatment Dissemination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2006
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 Jun 2007 (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 the effectiveness of abuse-focused cognitive behavioral therapy that is provided by a community health clinic in addressing the behavioral and emotional health needs of children and adolescents whose parents have used physical disciplinary action.
Detailed description
Child physical abuse is a common public health problem that has been associated with significant psychosocial and physical health problems among children. Abuse-focused cognitive-behavioral therapy (AF-CBT) has been identified as an effective treatment strategy for dealing with child physical abuse. The main component of AF-CBT, cognitive behavioral therapy (CBT), is a type of psychotherapy in which everyday thoughts and behaviors are modified to improve mental health problems, such as depression or anxiety. AF-CBT uses CBT techniques to specifically focus on improving the mental health problems associated with physical abuse. In this study, AF-CBT will incorporate individual and family CBT and will be adapted by community practitioners to maximize its effectiveness in a community health care setting. This study will determine the effectiveness of AF-CBT, provided by a community health clinic, in addressing the behavioral and emotional health needs of children and adolescents whose parents have used physical disciplinary action.
Participants in this study will include practitioners, their supervisors, and their patients. Practitioners will be randomly assigned to provide either treatment as usual (TAU) or the AF-CBT intervention for 3 to 6 months. Patient participants will continue to see their regular practitioner, but will receive the type of treatment to which their practitioner has been assigned. Practitioners who are assigned to TAU will continue to attend training workshops or seminars as a part of their clinics' routine policies and their current personal practices. Practitioners who are assigned to AF-CBT will first receive training in the treatment method. The training curriculum will include a published treatment book, intensive training sessions, which will occur weekly for 8 hours over 4 weeks, handouts that illustrate key therapeutic information and exercises, and ongoing case consultation reviews for 5 months.
Parent and child participants will meet with practitioners at times to be decided based on individual patient needs. All parents and children will be asked to participate in interviews to assess symptoms and outcomes before attending any treatment sessions with the practitioner, 6 months, 12 months, 18 months,and 30 months after baseline. Parents and children will also complete questionnaires each time they meet with the practitioner. This study will also assess the ability of the practitioners and supervisors to carry out AF-CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF-CBT | Experimental | Behavioral: Abused-focused cognitive behavioral therapy (AF-CBT)Participants will receive abused-focused cognitive behavioral therapy |
| TAU | Active comparator | Behavioral: Treatment as usual (TAU)Participants will receive treatment as usual |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child is between 5 and 15 years of age
- Any one of the following child discipline criteria are met within the past 12 months:
- Child and caregiver (preferably, not necessarily, the offending or at-risk caregiver, and regardless of whether they live together currently), will participate in services, and should be able to make progress in the proposed agency services;
- Parent/legal guardian must agree to informed consent for child and there is no immediate plan for a change in parental rights (e.g., child going to pre-adoptive foster care).
Key exclusion criteria (2 listed)
- Child or parent is identified by agency staff as exhibiting serious psychological or intellectual impairment that would prevent minimal participation or progress in treatment (e.g., severe drug dependence, active psychosis, or pervasive developmental disorder)
- Child is in placement without access to a legal guardian who can provide informed consent OR a change in parental rights is likely to occur in the near future
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 |
|---|---|---|
| Abused-focused cognitive behavioral therapy (AF-CBT)Practitioners will be randomly assigned to provide the AF-CBT treatment for 3 to 6 months. Patient participants will continue to see their regular practitioner, but will receive AF-CBT at treatment visits. Practitioners who are assigned to AF-CBT will first receive training in the treatment method. The training curriculum will include a published treatment book, intensive training sessions, which will occur weekly for 8 hours over 4 weeks, handouts that illustrate key therapeutic information and exercises, and ongoing case consultation reviews for 5 months. | Behavioural | AF-CBT |
| Treatment as usual (TAU)This condition consists of those practitioners in each agency who will not receive study training in AF-CBT. These practitioners will simply provide services as available within their agencies. | Behavioural | TAU |
Primary outcome
Family outcomes, including client engagement in service
Time frame: Measured at baseline and Months 6, 12, 18, 24, and 30
Mental health functioning (symptom improvement, family support, more appropriate parenting practices) and outside service use (social service system contact or child placement/disruption)
Time frame: Measured at baseline and Months 6, 12, 18, 24, and 30
Child welfare status (recidivism or re-injury rates)
Time frame: Measured at baseline and Months 6, 12, 18, 24, and 30
2 secondary outcomes
Practitioner knowledge about treatment
Time frame: Measured at baseline and Months 6, 12, 18, 24, and 30
Practitioner competency and patient's satisfaction with treatment
Time frame: Measured at baseline and Months 6, 12, 18, 24, and 30
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 18 Feb 2013.
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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.
David J. Kolko, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abused-focused cognitive behavioral therapy (AF-CBT) and Treatment as usual (TAU) in people with Child Abuse, run by University of Pittsburgh 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 7 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: finished, as of the sponsor's last update on 18 Feb 2013. 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 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.
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?
Family outcomes, including client engagement in service (time frame: Measured at baseline and Months 6, 12, 18, 24, and 30). The study lists 3 primary outcomes in all. 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 18 Feb 2013.