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NCT Number: NCT04946253

SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care

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.

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Key information

Conditions

Child Behavior Problem Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders Oppositional Defiant Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University, Philadelphia, Pennsylvania, United States

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About this study

This study is a randomized, hybrid type 3 effectiveness-implementation trial to support the adoption of a chronic care model (CCM)-based intervention in pediatric primary care settings by testing the impact of implementation strategies directed towards the provider care team (TEAM) or practice leadership (LEAD) level. The treatment investigators seek to deliver here is called Doctor Office Collaborative Care (DOCC), an evidence-based intervention for the management of child behavior problems and comorbid ADHD. The implementation strategies being tested to enhance DOCC uptake include TEAM coaching/consultation strategies, which will be delivered to care team providers and target provider competency to deliver DOCC, and LEAD facilitation strategies, which will be delivered to practice leaders and target organizational support of DOCC delivery. These multi-level implementation strategies have not been formally evaluated to learn about their separate and combined effects in any randomized clinical trial conducted in pediatric primary care. Such information is needed to optimize our approaches to promoting the implementation of a CCM-based intervention in pediatric practice.

The sample includes up to 24 primary care practices from a statewide network and other networks or states. After standard training in the DOCC EBP, all practices will be randomized to one of four implementation conditions: 1) No TEAM or LEAD (ongoing technical support only); 2) TEAM implementation; 3) LEAD implementation, or 4) TEAM+LEAD implementation. TEAM and LEAD implementation will be delivered via videoconference on a graded schedule. Care teams will deliver DOCC to up to 25 children (or more if requested by the practice) who meet a clinical cutoff for modest behavior problems and their caregivers. Investigators will collect practice/provider measures from enrolled practice staff (0, 6, 12, 18, 24 months) and caregivers over several timepoints (0, 3, 6, 12 months) to support all analyses evaluating implementation and treatment outcomes, mediation, and moderation. By proposing one of the first large pragmatic pediatric trials of a CCM-based evidence-based intervention to address these aims in response to RFA-MH-18-701 and the NIMH's Strategic Plan (4.2), this research will advance the implementation science knowledge needed to optimize promising strategies for promoting the delivery and scale-up of DOCC in a pediatric medical home.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DOCC: Evidence-based treatment for disruptive behavior and ADHD

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. Total number of DOCC encounters

    Time frame: Throughout services after each contact, up to 12 months

    As part of a short checklist-style progress note completed after each service contact and housed in the study's web-based patient registry dashboard, providers will document each DOCC encounter delivered to each family. These encounters include referral, assessment, treatment or medication delivery, medication or treatment review/monitoring, case management, review of emergent symptoms, and care management and consultation meetings involving a family member. Investigators will report the total number of DOCC encounters delivered to each family during the intervention phase.

  2. Care management competencies and functions

    Time frame: At provider baseline

    The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.

  3. Change from baseline in care management competencies and functions at 6 months

    Time frame: 6 months after provider baseline

    The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.

  4. Change from baseline in care management competencies and functions at 12 months

    Time frame: 12 months after provider baseline

    The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.

  5. Change from baseline in care management competencies and functions at 18 months

    Time frame: 18 months after provider baseline

    The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.

  6. Change from baseline in care management competencies and functions at 24 months

    Time frame: 24 months after provider baseline

    The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.

  7. Severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community

    Time frame: At caregiver baseline

    To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24).

  8. 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

    To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24).

  9. 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

    To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24).

  10. 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

    To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24).

  11. Severity of ADHD, ODD/CD, and ANX/DEP symptoms at school

    Time frame: At teacher baseline

    Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring).

  12. 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

    Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring).

  13. 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

    Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring).

  14. 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

    Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring).

  15. Pediatric Health Quality

    Time frame: At caregiver baseline

    Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP.

  16. Change from baseline in Pediatric Health Quality at 3 months

    Time frame: 3 months after caregiver baseline

    Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP.

  17. Change from baseline in Pediatric Health Quality at 3 months

    Time frame: 6 months after caregiver baseline

    Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP.

  18. Change from baseline in Pediatric Health Quality at 12 months

    Time frame: 12 months after caregiver baseline

    Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP.

  19. Professional perceptions of study experiences at 18 months

    Time frame: 18 months after professional baseline

    Professionals will be invited to participate in an 18-month qualitative interview after they complete their 18-month online assessment. The purpose of this research interview is to provide feedback about their experiences with different aspects of this study, such as: learning and using the DOCC intervention, working as a team, participating any facilitation calls, and completing our research tasks. The interview gives us unique information about their perspective on these topics that can help us extend what we can learn from their surveys and then modify or tailor any of these methods to better support feasibility and acceptability. All responses will be thematically coded and summarized for interpretation.

Study contacts

Contact information is provided by the study sponsor or research team.

David J Kolko, PhD

CONTACT

[email protected]

4122465888

Kevin M Rumbarger, BA

CONTACT

[email protected]

4128867539

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • American Academy of Pediatrics
  • Drexel University
  • NYU Langone Health
  • National Institute of Mental Health (NIMH)
  • Pennsylvania American Academy of Pediatrics
  • University of Michigan

Registry information

Official study title

Care Team and Practice Level Implementation Strategies to Optimize Pediatric Collaborative Care: A Cluster-Randomized Trial

Acronym: SKIPforPA

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2021
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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