Attention Deficit and Disruptive Behavior Disorders Clinical Trial
Official title:
Collaborative Mental Health Services for Behavior Disorders in Primary Care
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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