Improving access to care and clinical outcome for pediatric behavioral problems: a randomized trial of a nurse-administered intervention in primary care.
David J Kolko, John V Campo, Kelly Kelleher...
https://pubmed.ncbi.nlm.nih.gov/20495474Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04946253
Care Team and Practice Level Implementation Strategies to Optimize Pediatric Collaborative Care: A Cluster-Randomized Trial
Led by University of Pittsburgh · Updated on 2026-02-09
450
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
A
American Academy of Pediatrics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized clinical trial to evaluate ways to improve the use of an evidence-based care model called Doctor Office Collaborative Care (DOCC) in pediatric primary care settings. This intervention targets the management of childhood behavior problems and comorbid ADHD. The study focuses on testing implementation strategies aimed at either the care team providers or the practice leadership to see how these approaches impact the delivery and uptake of DOCC in diverse pediatric offices. The trial involves up to 24 pediatric primary care practices that will first receive standard DOCC training and materials. Practices are then randomly assigned to one of four groups: no additional support beyond training, support for the care team through coaching and consultation (TEAM), support for practice leadership through facilitation (LEAD), or both TEAM and LEAD support combined. TEAM and LEAD strategies are delivered via regular videoconference meetings over time to enhance the delivery of DOCC treatment sessions focused on behavior and ADHD management for children. Participants include practice staff members and caregivers of children aged 5 to 12 with behavior problems. Data is collected from practice staff at multiple time points up to 24 months and from caregivers up to 12 months to measure the implementation and treatment outcomes. Researchers assess the number of DOCC encounters, care management skills, and changes in symptoms of ADHD, oppositional defiant disorder, conduct disorder, anxiety, and depression, as well as pediatric health quality. The study aims to provide knowledge on how to best support pediatric practices in delivering this collaborative care model.
CONDITIONS
Brief Title
SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Primary care providers employed at one of the participating pediatric primary care practices
- Behavioral health resources identified as care managers employed at participating pediatric primary care practices
- Senior leaders with practice-level leadership roles and administrative responsibilities at participating pediatric primary care practices
- Practice managers responsible for day-to-day operations at participating pediatric primary care practices
- Caregivers at least 18 years old with parental rights for a child aged 5 to 12 years exhibiting modest behavior problems
You will not qualify if you...
- Caregivers already enrolled in the study as the caregiver for a different child (e.g., sibling)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) to determine eligibility
Treatment
Duration - Up to 12 months of DOCC treatment sessions
Participants receive the Doctor Office Collaborative Care (DOCC) intervention, an evidence-based behavioral treatment for child behavior problems and ADHD. Practices are randomized to receive different implementation support strategies including coaching for care teams (TEAM), facilitation for practice leadership (LEAD), both, or standard implementation with technical support only. Treatment involves sessions with caregivers and children covering behavior management and ADHD topics.
Multiple treatment sessions scheduled by practices with caregivers and children; implementation support includes approximately monthly virtual meetings with care teams and/or practice leaders depending on assigned group
Follow-up
Duration - Up to 24 months of follow-up assessments after treatment begins
Caregivers, providers, and teachers complete assessments at multiple timepoints to evaluate changes in symptoms, care management competencies, and professional perceptions over the course of 24 months.
Assessments occur at baseline, 3, 6, 12, 18, and 24 months depending on participant role; visits may be virtual or in-person
Trial Site Locations
Total: 2 locations
1
Drexel University
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Actively Recruiting
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Research Team
K
Kevin M Rumbarger, BA
D
David J Kolko, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Doctor-office collaborative care for pediatric behavioral problems: a preliminary clinical trial.
David J Kolko, John V Campo, Amy M Kilbourne...
https://pubmed.ncbi.nlm.nih.gov/22064876Collaborative care outcomes for pediatric behavioral health problems: a cluster randomized trial.
David J Kolko, John Campo, Amy M Kilbourne...
https://pubmed.ncbi.nlm.nih.gov/24664093Effects of Collaborative Care for Comorbid Attention Deficit Hyperactivity Disorder Among Children With Behavior Problems in Pediatric Primary Care.
David J Kolko, Jonathan A Hart, John Campo...
https://pubmed.ncbi.nlm.nih.gov/32503395Effects of Primary Care Provider Characteristics on Changes in Behavioral Health Delivery During a Collaborative Care Trial.
Elizabeth A McGuier, David J Kolko, K Ashana Ramsook...
https://pubmed.ncbi.nlm.nih.gov/31760174Collaborative mental health care for pediatric behavior disorders in primary care: Does it reduce mental health care costs?
Hao Yu, David J Kolko, Eunice Torres
https://pubmed.ncbi.nlm.nih.gov/28333516Team functioning and implementation of innovations in healthcare and human service settings: a systematic review protocol.
Elizabeth A McGuier, David J Kolko, Mary Lou Klem...
https://pubmed.ncbi.nlm.nih.gov/34174962Care team and practice-level implementation strategies to optimize pediatric collaborative care: study protocol for a cluster-randomized hybrid type III trial.
David J Kolko, Elizabeth A McGuier, Renee Turchi...
https://pubmed.ncbi.nlm.nih.gov/35193619