Effectiveness of Collaborative Services in Primary Care for Treating Children With Behavior Disorders (SKIP)
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|ClinicalTrials.gov Identifier: NCT00600470|
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : June 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit and Disruptive Behavior Disorders||Behavioral: Doctor-office collaborative care (DOCC) management Behavioral: Treatment as usual (TAU)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||858 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Collaborative Mental Health Services for Behavior Disorders in Primary Care|
|Study Start Date :||September 2000|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Doctor-office collaborative care management
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.
Other Name: DOCC
Active Comparator: 2
Treatment as usual: psychoeducation and outside referral to treatment (PORT). In papers, this arm is referred to as "Enhanced Usual Care (EUC)".
Behavioral: Treatment as usual (TAU)
TAU involves routine care: psychoeducation and referral to outside providers.
Other Name: PORT
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600470
|United States, Pennsylvania|
|Western Psychiatric Institute and Clinic (WPIC)|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||David J. Kolko, PhD||University of Pittsburgh|