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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Kolko, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00600470
First received: January 14, 2008
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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
Attention Deficit and Disruptive Behavior Disorders
Behavioral: Doctor-office collaborative care (DOCC) management
Behavioral: Treatment as usual (TAU)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Collaborative Mental Health Services for Behavior Disorders in Primary Care

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 263
Study Start Date: October 2007
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)
Behavioral: Treatment as usual (TAU)
TAU involves routine care: psychoeducation and referral to outside providers.
Other Name: PORT

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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600470

Contacts
Contact: Betsy A. Holden, MEd, LPC 412-246-5886 austines@upmc.edu

Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic (WPIC) Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Eunice B. Torres, MS    412-246-5286    Torreseb@upmc.edu   
Sub-Investigator: Abigail B Schlesinger, MD         
Sub-Investigator: Stephen Wisniewski, PhD         
Sub-Investigator: Dana Rofey, PhD         
Sub-Investigator: David Wolfson, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David J. Kolko, PhD University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Kolko, Professor of Psychiatry, Psychology, and Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00600470     History of Changes
Other Study ID Numbers: R01 MH063272, R01MH063272, DSIR 84-CTS
Study First Received: January 14, 2008
Last Updated: February 15, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Behavior Problems
Behavior Disorders

Additional relevant MeSH terms:
Disease
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on September 15, 2014