Effectiveness of Collaborative Services in Primary Care for Treating Children With Behavior Disorders (SKIP)
| Tracking Information | |||||
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| First Received Date ICMJE | January 14, 2008 | ||||
| Last Updated Date | February 15, 2013 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Vanderbilt Parent ADHD Rating Scale; Child Health and Illness Profile; Pediatric Quality of Life Inventory; Individualized Goal Attainment Rating [ Time Frame: Measured at baseline and at Months 6, 12, 18, 24, and 30 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Vanderbilt Parent ADHD Rating Scale; Child Health and Illness Profile; Pediatric Quality of Life Inventory; Individualized Goal Attainment Rating [ Time Frame: Measured at baseline and at Months 6, 12, 18, and 30 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00600470 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Parenting Stress Index; Brief Symptom Inventory; Alabama Parenting Questionnaire; Services Assessment for Children and Adolescents [ Time Frame: Measured at baseline and at Months 6, 12, 18, 24, and 30 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Parenting Stress Index; Brief Symptom Inventory; Alabama Parenting Questionnaire; Services Assessment for Children and Adolescents [ Time Frame: Measured at baseline and at Months 6, 12, 18, and 30 ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Collaborative Services in Primary Care for Treating Children With Behavior Disorders | ||||
| Official Title ICMJE | Collaborative Mental Health Services for Behavior Disorders in Primary Care | ||||
| Brief Summary | 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. |
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| Detailed Description | 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, 24, and 30 after the initial assessment. Each assessment will last 2 to 3 hours and will include self-report and interview questionnaires. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Attention Deficit and Disruptive Behavior Disorders | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 263 | ||||
| Estimated Completion Date | March 2013 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00600470 | ||||
| Other Study ID Numbers ICMJE | R01 MH063272, R01MH063272, DSIR 84-CTS | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | David Kolko, University of Pittsburgh | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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