NCT00600470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
858

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

12.9 years

First QC Date

January 14, 2008

Last Update Submit

May 29, 2015

Conditions

Attention Deficit and Disruptive Behavior Disorders

Keywords

Behavior ProblemsBehavior Disorders

Outcome Measures

Primary Outcomes (1)

  • Vanderbilt Parent ADHD Rating Scale; Child Health and Illness Profile; Pediatric Quality of Life Inventory; Individualized Goal Attainment Rating

    Measured at baseline and at Months 6, 12, 18, 24, and 30

Secondary Outcomes (1)

  • Parenting Stress Index; Brief Symptom Inventory; Alabama Parenting Questionnaire; Services Assessment for Children and Adolescents

    Measured at baseline and at Months 6, 12, 18, 24, and 30

Study Arms (2)

1

EXPERIMENTAL

Doctor-office collaborative care management

Behavioral: Doctor-office collaborative care (DOCC) management

2

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual (TAU)

Interventions

Doctor-office collaborative care (DOCC) managementBEHAVIORAL

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.

Also known as: DOCC
1
Treatment as usual (TAU)BEHAVIORAL

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

Also known as: PORT
2

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic (WPIC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • 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.

    PMID: 24664093DERIVED

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior DisordersMental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders

Study Officials

  • David J. Kolko, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry, Psychology, and Pediatrics

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

September 1, 2000

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

US(1)