Expired Study
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Pittsburgh, Pennsylvania 15213


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.


Study summary:

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.


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


Study is Available At:


Original ID:

R01 MH063272


NCT ID:

NCT00600470


Secondary ID:

R01MH063272


Study Acronym:

SKIP


Brief Title:

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


Official Title:

Collaborative Mental Health Services for Behavior Disorders in Primary Care


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

5 Years


Maximum Age:

12 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

858


Enrollment Type:

Actual


Overall Contact Information

Official Name:David J. Kolko, PhD
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:September 2000
Completion Date:August 2013
Completion Type:Actual
Primary Completion Date:August 2013
Primary Completion Type:Actual
Verification Date:May 2015
Last Changed Date:May 29, 2015
First Received Date:January 14, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Doctor-office collaborative care (DOCC) management
Description: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 communi
Arm Name:1
Other Name:DOCC
Intervention Type:Behavioral
Name:Treatment as usual (TAU)
Description:TAU involves routine care: psychoeducation and referral to outside providers.
Arm Name:2
Other Name:PORT

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Treatment as usual: psychoeducation and outside referral to treatment (PORT). In papers, this arm is referred to as "Enhanced Usual Care (EUC)".
Study Arm Type:Experimental
Arm Name:1
Description:Doctor-office collaborative care management

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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