Abuse-Focused Cognitive Behavioral Therapy for Children Who Have Been Physically Abused (PFF)
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|ClinicalTrials.gov Identifier: NCT00494286|
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : February 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Child Abuse||Behavioral: Abused-focused cognitive behavioral therapy (AF-CBT) Behavioral: Treatment as usual (TAU)||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Treatment of Child Physical Abuse: An Effectiveness Trial (PFF)|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Participants will receive abused-focused cognitive behavioral therapy
Behavioral: 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.
Active Comparator: TAU
Participants will receive treatment as usual
Behavioral: 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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494286
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15243|
|Principal Investigator:||David J. Kolko, PhD||University of Pittsburgh|