- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00494286
Abuse-Focused Cognitive Behavioral Therapy for Children Who Have Been Physically Abused (PFF)
Treatment of Child Physical Abuse: An Effectiveness Trial (PFF)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15243
- Bellefield Towers
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AF-CBT
Participants will receive abused-focused cognitive behavioral therapy
|
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.
|
|
Active Comparator: TAU
Participants will receive treatment as usual
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Family outcomes, including client engagement in service
Time Frame: Measured at baseline and Months 6, 12, 18, 24, and 30
|
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
|
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
|
Measured at baseline and Months 6, 12, 18, 24, and 30
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Practitioner knowledge about treatment
Time Frame: Measured at baseline and Months 6, 12, 18, 24, and 30
|
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
|
Measured at baseline and Months 6, 12, 18, 24, and 30
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David J. Kolko, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01MH074737 (U.S. NIH Grant/Contract)
- DSIR CT-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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