Abuse-Focused Cognitive Behavioral Therapy for Children Who Have Been Physically Abused (PFF)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Kolko, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00494286
First received: June 27, 2007
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Child Abuse
Behavioral: Abused-focused cognitive behavioral therapy (AF-CBT)
Behavioral: Treatment as usual (TAU)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Child Physical Abuse: An Effectiveness Trial (PFF)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Family outcomes, including client engagement in service [ Time Frame: Measured at baseline and Months 6, 12, 18, 24, and 30 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Child welfare status (recidivism or re-injury rates) [ Time Frame: Measured at baseline and Months 6, 12, 18, 24, and 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Practitioner knowledge about treatment [ Time Frame: Measured at baseline and Months 6, 12, 18, 24, and 30 ] [ Designated as safety issue: No ]
  • Practitioner competency and patient's satisfaction with treatment [ Time Frame: Measured at baseline and Months 6, 12, 18, 24, and 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: September 2006
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AF-CBT
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. the parent reports that the child has been the target of physical force/contact (e.g. discipline, punishment),
    2. 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
    3. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494286

Locations
United States, Pennsylvania
Bellefield Towers
Pittsburgh, Pennsylvania, United States, 15243
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David J. Kolko, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: David Kolko, Professor of Psychiatry, Psychology, and Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00494286     History of Changes
Other Study ID Numbers: R01 MH074737, R01MH074737, DSIR CT-C
Study First Received: June 27, 2007
Last Updated: February 15, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Abuse Focused Cognitive Behavioral Therapy
Treatment Effectiveness Research
Treatment Dissemination

ClinicalTrials.gov processed this record on October 23, 2014