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

NCT00494286 | Completed Phase 1 DMC

• 2 other identifiers: R01MH074737DSIR CT-C
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Abuse

Keywords

Abuse Focused Cognitive Behavioral Therapy; Treatment Effectiveness Research; Treatment Dissemination

Outcome Measures

Primary Outcomes (3)

• Family outcomes, including client engagement in service

  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 at baseline and Months 6, 12, 18, 24, and 30

• Child welfare status (recidivism or re-injury rates)

  Measured at baseline and Months 6, 12, 18, 24, and 30

Secondary Outcomes (2)

• Practitioner knowledge about treatment

  Measured at baseline and Months 6, 12, 18, 24, and 30

• Practitioner competency and patient's satisfaction with treatment

  Measured at baseline and Months 6, 12, 18, 24, and 30

Study Arms (2)

AF-CBT

EXPERIMENTAL

Participants will receive abused-focused cognitive behavioral therapy

Behavioral: Abused-focused cognitive behavioral therapy (AF-CBT)

TAU

ACTIVE COMPARATOR

Participants will receive treatment as usual

Behavioral: Treatment as usual (TAU)

Interventions

Abused-focused cognitive behavioral therapy (AF-CBT) 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.

AF-CBT

Treatment as usual (TAU) 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.

TAU

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Bellefield Towers

Pittsburgh, Pennsylvania, 15243, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• David J. Kolko, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, Psychology, and Pediatrics

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 29, 2007
• Study Start: September 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 18, 2013

Record last verified: 2013-02

Locations

US (1)