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

January 14, 2008
February 15, 2013
October 2007
March 2013   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00600470 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Effectiveness of Collaborative Services in Primary Care for Treating Children With Behavior Disorders
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit and Disruptive Behavior Disorders
  • 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
  • Behavioral: Treatment as usual (TAU)
    TAU involves routine care: psychoeducation and referral to outside providers.
    Other Name: PORT
  • Experimental: 1
    Doctor-office collaborative care management
    Intervention: Behavioral: Doctor-office collaborative care (DOCC) management
  • Active Comparator: 2
    Treatment as usual: psychoeducation and outside referral to treatment (PORT)
    Intervention: Behavioral: Treatment as usual (TAU)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
263
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
5 Years to 12 Years
No
Contact: Betsy A. Holden, MEd, LPC 412-246-5886 austines@upmc.edu
United States
 
NCT00600470
R01 MH063272, R01MH063272, DSIR 84-CTS
Yes
David Kolko, University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: David J. Kolko, PhD University of Pittsburgh
University of Pittsburgh
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP