NCT04946253 SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care
| NCT ID | NCT04946253 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Child Behavior Problem |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2021-11-28 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2021-11-28 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In a prior application (MH064372), the investigators' treatment research program (Services for Kids In Primary-care, SKIP) developed and tested a chronic care model-based intervention, called Doctor Office Collaborative Care (DOCC), that was found to be effective in the management of childhood behavior problems and comorbid ADHD. In the "SKIP for PA Study", the investigators propose to conduct a randomized clinical trial to evaluate the effects of team- and practice leadership-level implementation strategies designed to enhance the use and uptake of DOCC in diverse pediatric primary care offices.
Eligibility Criteria
The investigators propose to recruit 4 types of practice provider participants (PCP = primary care provider, CM = care manager, SL = Senior Leader, PM = practice manager) as well as caregiver participants. Inclusion Criteria: * PCP Participants: * Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. * Identified by the practice as a Primary Care Provider * CM Participants: * Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. * Identified by the practice as a Behavioral Health Resource who delivers and coordinates behavioral health care in the practice, who will function in the study as a care manager. * SL Participants: * Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. * Identified by the practice as the Senior Leader. * Have a practice-level leadership role such as Medical Director or a clinical/practice leader * Have administrative responsibilities related to patient care and/or the operations/management of the practice * PM Participants: * Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team. * Identified by the practice as the Practice Manager or equivalent position * Are responsible for day-to-day practice operations, such as personnel management, billing, and compliance with regulations, in the pediatric practice. * Caregiver Participants: * Have a child age 5-12 years old who exhibits at least a modest level of behavior problems (Caregiver Participants) * Are at least 18 years of age (Caregiver participants) * Have parental rights for this child (Caregiver participants) Exclusion Criteria: * Caregivers * Already enrolled in the study as the caregiver to a different child (e.g., sibling) (Caregiver participants)
Contact & Investigator
David J Kolko, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT04946253 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Child Behavior Problem. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04946253 currently recruiting?
Yes, NCT04946253 is actively recruiting participants. Contact the research team at rumbargerkm@upmc.edu for enrollment information.
Where is the NCT04946253 trial being conducted?
This trial is being conducted at Philadelphia, United States, Pittsburgh, United States.
Who is sponsoring the NCT04946253 clinical trial?
NCT04946253 is sponsored by University of Pittsburgh. The principal investigator is David J Kolko, PhD at University of Pittsburgh. The trial plans to enroll 450 participants.