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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00600470 |
This study will evaluate the effectiveness of a doctor-office collaborative care approach in treating children with disruptive behavior problems in the pediatric primary care setting.
Condition | Intervention | Phase |
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Attention Deficit and Disruptive Behavior Disorders |
Behavioral: Doctor-office collaborative care (DOCC) management Behavioral: Treatment as usual (TAU) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Collaborative Mental Health Services for Behavior Disorders in Primary Care |
Estimated Enrollment: | 263 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Doctor-office collaborative care management
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Behavioral: Doctor-office collaborative care (DOCC) management
DOCC is an evidence-based psychosocial treatment approach that incorporates (1) adaptation of an evidence-based collaborative care approach using the chronic care model and participatory management theory to enhance training, implementation, and sustainability; (2) revised protocol content that includes medication management for ADHD, brief anxiety management, and attention to parental/partner dysfunction; (3) technological developments to facilitate screening/assessment, monitoring, and communication; and (4) an improved methodology that includes new samples, measures, and settings.
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2: Active Comparator
Treatment as usual: psychoeducation and outside referral to treatment (PORT)
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Behavioral: Treatment as usual (TAU)
TAU involves routine care: psychoeducation and referral to outside providers.
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Disruptive behavior problems (DBP) involve a behavioral tendency of children and adolescents to continually disregard basic social rules and the rights of others. Symptoms of DBP include problematic aggression, antisocial tendencies, serious defiance of rules, and temper tantrums. Children or adolescents with DBP display this type of behavior at school, home, or other social situations, often affecting family life, academic performance, and relations with others. The causes of DBP are believed to be both environmental and biological. Children most at risk for DBP are those who have low birth weight, attention deficit hyperactivity disorder (ADHD), or a history of abuse or neglect. Behavioral therapy that targets parent and child skills has shown to be the most effective treatment for DBP. This study will evaluate the effectiveness of a doctor-office collaborative care (DOCC) approach in treating children with DBP in the pediatric primary care setting. The study is a continuation and extension of the parent study, Services for Kids in Primary Care (SKIP).
Participants in this single blind study will be randomly assigned to one of two treatment groups: doctor-office collaborative care (DOCC) or treatment as usual (TAU). Treatment will take place at one of eight participating primary care practices, each randomly assigned to either DOCC or TAU. All participants will undergo an initial assessment that will include a clinical evaluation with the care manager and research questionnaires. The families participating in the practices assigned to DOCC will receive cognitive behavioral therapy (CBT), parent management training (PMT), and ADHD management training. Participants will also complete ongoing behavioral questionnaires. There will be on average 12 DOCC sessions, lasting between 30 and 90 minutes, held in the primary care office. The sessions will occur over a 3- to 6-month period. The families participating in the practices assigned to TAU will receive a full review of initial assessment findings and specific recommendations for services in the community that would meet the clinical needs of the child participant. The parent/guardian of the child will also be provided psychoeducational resources via Web sites, literature, or reference materials. Lastly, participants in TAU will receive a follow-up call between 2 and 4 weeks after the initial assessment to assist with finding community programs or additional resource identification. All participants in both groups will undergo follow-up assessments at Months 6, 12, 18, and 30 after the initial assessment. Each assessment will last 2 to 3 hours and will include self-report and interview questionnaires.
Ages Eligible for Study: | 5 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Betsy A. Holden, MEd, LPC | 412-246-5886 | austines@upmc.edu |
United States, Pennsylvania | |
Western Psychiatric Institute and Clinic (WPIC) | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Betsy A. Holden, MEd, LPC 412-246-5886 austines@upmc.edu | |
Sub-Investigator: Abigail B Schlesinger, MD | |
Sub-Investigator: Stephen Wisniewski, PhD | |
Sub-Investigator: Dana Rofey, PhD | |
Sub-Investigator: David Wolfson, MD |
Principal Investigator: | David J. Kolko, PhD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh School of Medicine ( David J. Kolko, PhD ) |
Study ID Numbers: | 2R01 MH063272, DSIR 84-CTS |
Study First Received: | January 14, 2008 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00600470 |
Health Authority: | United States: Federal Government |
Behavior Problems Behavior Disorders |
Mental Disorders Mental Disorders Diagnosed in Childhood Attention Deficit and Disruptive Behavior Disorders |
Pathologic Processes Disease |