Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT04946253

Conditions

Child Behavior Problem

Attention Deficit and Disruptive Behavior Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DOCC: Evidence-based treatment for disruptive behavior and ADHD

TEAM: Implementation support strategies at the care team level following standard implementation of DOCC

Implementation support strategies at the leadership level following standard implementation of DOCC

Study Details

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.

Conditions

Child Behavior Problem

Attention Deficit and Disruptive Behavior Disorders

Study ID

NCT04946253

Start date

Nov 28, 2021

Status verified date

Feb, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: DOCC with standard implementation (No TEAM or LEAD)

Practices in this arm will receive DOCC materials/training and technical support, but will not receive care team coaching/consultation (TEAM) or practice leadership facilitation (LEAD) after the training phase.

experimental: DOCC with TEAM implementation

Practices in this arm will receive DOCC training and materials and one type of implementation support after the training: coaching/consultation for the provider care team (TEAM).

experimental: DOCC with LEAD implementation

Practices in this arm will receive DOCC training and materials and only one type of implementation support after the training: facilitation for practice leadership (LEAD).

experimental: DOCC with TEAM + LEAD implementation

Practices in this arm will receive DOCC training and materials and both types of implementation support after the training: coaching/consultation for the provider care team (TEAM) and facilitation for practice leadership (LEAD).

Interventions

DOCC: Evidence-based treatment for disruptive behavior and ADHD

Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. The content covers key topics related to the treatment of behavior problems (e.g., self-management, positive parenting) and ADHD (e.g., psychoeducation, medication).

TEAM: Implementation support strategies at the care team level following standard implementation of DOCC

Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. Coaching and consultation will be provided to the provider care team to support the use of collaborative care for behavior problems and ADHD. The TEAM intervention includes regular virtual meetings or calls with the providers (about once/month, on average) that cover core chronic care model functions, including registry use, case-finding, collaborative care team roles, and workflows outlining how DOCC is delivered in the practice.

Implementation support strategies at the leadership level following standard implementation of DOCC

Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. Practice facilitation will be provided to practice leaders to help them support the care team's use of collaborative care for behavior problems and ADHD. The LEAD intervention includes regular virtual meetings or calls with practice leaders (about once/month, on average) that cover the assessment of practice capacity/barriers, ways to overcome organizational barriers and support staff use of DOCC, promoting innovation, and leveraging practice resources to support DOCC delivery and maintenance in the practice.

Primary outcome measure

  • Total number of DOCC encounters [ Time Frame: Throughout services after each contact, up to 12 months ]
  • Care management competencies and functions [ Time Frame: At provider baseline ]
  • Change from baseline in care management competencies and functions at 6 months [ Time Frame: 6 months after provider baseline ]
  • Change from baseline in care management competencies and functions at 12 months [ Time Frame: 12 months after provider baseline ]
  • Change from baseline in care management competencies and functions at 18 months [ Time Frame: 18 months after provider baseline ]
  • Change from baseline in care management competencies and functions at 24 months [ Time Frame: 24 months after provider baseline ]
  • Severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community [ Time Frame: At caregiver baseline ]
  • Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 3 months [ Time Frame: 3 months after caregiver baseline ]
  • Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 6 months [ Time Frame: 6 months after caregiver baseline ]
  • Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 12 months [ Time Frame: 12 months after caregiver baseline ]
  • Severity of ADHD, ODD/CD, and ANX/DEP symptoms at school [ Time Frame: At teacher baseline ]
  • Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 3 months [ Time Frame: 3 months after teacher baseline ]
  • Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 6 months [ Time Frame: 6 months after teacher baseline ]
  • Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 12 months [ Time Frame: 12 months after teacher baseline ]
  • Pediatric Health Quality [ Time Frame: At caregiver baseline ]
  • Change from baseline in Pediatric Health Quality at 3 months [ Time Frame: 3 months after caregiver baseline ]
  • Change from baseline in Pediatric Health Quality at 3 months [ Time Frame: 6 months after caregiver baseline ]
  • Change from baseline in Pediatric Health Quality at 12 months [ Time Frame: 12 months after caregiver baseline ]
  • Professional perceptions of study experiences at 18 months [ Time Frame: 18 months after professional baseline ]

Central Contacts and Locations

Central contacts

Kevin M Rumbarger, BA

4128867539rumbargerkm@upmc.edu

David J Kolko, PhD

4122465888kolkodj@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contacts

David J Kolko, PhD

4122465888kolkodj@upmc.edu

Principal Investigator:

David J Kolko, PhD

More Information

Sponsor

University of Pittsburgh

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • Oppositional Defiant Disorder
  • Attention Deficit Hyperactivity Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-02-09.