Effectiveness of Collaborative Services in Primary Care for Treating Children With Behavior Disorders

NCT ID: NCT00600470

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 858 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2013-08-31

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.

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.

Conditions

Attention Deficit and Disruptive Behavior Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Doctor-office collaborative care management

Group Type: EXPERIMENTAL

Doctor-office collaborative care (DOCC) management

Intervention Type: BEHAVIORAL

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.

2

Treatment as usual: psychoeducation and outside referral to treatment (PORT). In papers, this arm is referred to as "Enhanced Usual Care (EUC)".

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

TAU involves routine care: psychoeducation and referral to outside providers.

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as usual (TAU)

TAU involves routine care: psychoeducation and referral to outside providers.

Intervention Type: BEHAVIORAL

Other Intervention Names

DOCC; PORT

Eligibility Criteria

Inclusion Criteria

• Score of 75% on externalizing scale of PSC-17: score less than or equal to 6
• Parent/guardian is concerned about the child's mental health
• At least one parent/guardian who resides with the child is willing to participate in services and has signed an informed consent giving permission for the child to participate

Exclusion Criteria

• Child is currently prescribed and taking any of the following medications: SSRI, neuroleptics, antidepressants.
• Emergent psychiatric conditions that require additional treatments (e.g., eating disorder/anorexia nervosa, substance dependence, PTSD-active phase, OCD, PDD/Autism/Aspergers)
• Child has current suicidal or homicidal ideation with intent and a plan
• Participation in ongoing outpatient services and plans to continue

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

David Kolko

Professor of Psychiatry, Psychology, and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David J. Kolko, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Western Psychiatric Institute and Clinic (WPIC)

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Kolko DJ, Campo J, Kilbourne AM, Hart J, Sakolsky D, Wisniewski S. Collaborative care outcomes for pediatric behavioral health problems: a cluster randomized trial. Pediatrics. 2014 Apr;133(4):e981-92. doi: 10.1542/peds.2013-2516. Epub 2014 Mar 24.

Reference Type: DERIVED

PMID: 24664093 (View on PubMed)

Other Identifiers

R01MH063272

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 84-CTS

Identifier Type: -

Identifier Source: secondary_id

R01MH063272

Identifier Type: NIH

Identifier Source: org_study_id

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