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

NCT ID: NCT00494286

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2012-07-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AF-CBT

Participants will receive abused-focused cognitive behavioral therapy

Group Type: EXPERIMENTAL

Abused-focused cognitive behavioral therapy (AF-CBT)

Intervention Type: BEHAVIORAL

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.

TAU

Participants will receive treatment as usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

David Kolko

Professor of Psychiatry, Psychology, and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David J. Kolko, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Bellefield Towers

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

R01MH074737

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR CT-C

Identifier Type: -

Identifier Source: secondary_id

R01MH074737

Identifier Type: NIH

Identifier Source: org_study_id

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