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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04946253
Recruitment Status : Not yet recruiting
First Posted : June 30, 2021
Last Update Posted : June 30, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
American Academy of Pediatrics
Drexel University
NYU Langone Health
University of Michigan
Information provided by (Responsible Party):
David Kolko, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Child Behavior Problem Attention Deficit and Disruptive Behavior Disorders Behavioral: DOCC: Evidence-based treatment for disruptive behavior and ADHD Behavioral: TEAM: Implementation support strategies at the care team level following standard implementation of DOCC Behavioral: Implementation support strategies at the leadership level following standard implementation of DOCC Not Applicable

Detailed Description:

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 statewide sample includes 24 primary care practices from the Medical Home Program of the Pennsylvania Chapter of the American Academy of Pediatrics. 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 (or possibly in person) on a graded schedule. Care teams will deliver DOCC to 25 children 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The investigators propose a randomized trial using a factorial design to test effects of implementation support strategies on uptake of an evidence-based intervention (DOCC) in 24 primary care practices from the Medical Home Program of the Pennsylvania Chapter of the American Academy of Pediatrics. Practices will receive DOCC training in accord with the Replicating Effective Programs model. Practices will be randomized to 1 of 4 implementation support conditions: 1) No TEAM/LEAD (training and technical support only); 2) provider care team consultation (TEAM); 3) practice leadership facilitation (LEAD); and 4) combination of provider care team and leadership implementation (TEAM+LEAD). Care teams in each practice will identify families and deliver DOCC to 25 caregivers and their children with externalizing behavior. Investigators will collect measures from up to 250 practice staff over 5 assessments (24 months) and up to 600 caregivers over 4 assessments (12 months) to support analyses.
Masking: Single (Outcomes Assessor)
Masking Description: Participants are not directly informed of the implementation condition to which the practice site has been randomized. All formal standardized assessments will be conducted via secure electronic web-based data collection systems, limiting the potential for assessment bias. In the event that a caregiver requests that a staff member administer an assessment via phone, the assessor would be unaware of the implementation condition assigned to the child's practice where the caregiver receives care.
Primary Purpose: Treatment
Official Title: Care Team and Practice Level Implementation Strategies to Optimize Pediatric Collaborative Care: A Cluster-Randomized Trial
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: 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).

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).
Behavioral: 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).

Behavioral: 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.

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).
Behavioral: 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).

Behavioral: 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.

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).
Behavioral: 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).

Behavioral: 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.

Behavioral: 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 Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Practice Staff:

    • Employed at one of the twenty-four (24) pediatric primary care practices identified by the PA Chapter of the American Academy of Pediatrics. The investigators propose to recruit 4 types of participants (PCP = primary care provider, CM = care manager, MD = Medical Director, PM = practice manager)
    • Identified by the practice as a Primary Care Provider (PCP Participants)
    • Identified by the practice as the Behavioral Health Resource who delivers and coordinates behavioral health care in the practice, who will function in the study as a care manager. (CM Participants)
    • Identified by the practice as the Lead Physician/Medical Director. (MD Participants)
    • Identified by the practice as the Practice Manager (or equivalent position). (PM Participants)
  • Caregivers

    • 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)
    • Child's primary care provider is not enrolled in the study (Caregiver participants)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04946253


Contacts
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Contact: Kevin M Rumbarger, BA 4128867539 rumbargerkm@upmc.edu
Contact: Shelby M Parsons, BA 4122465895 parsonss6@upmc.edu

Locations
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United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19104
Contact: Renee M Turchi, MD, MPH    267-359-6051    renee.turchi@towerhealth.org   
Principal Investigator: Renee M Turchi, MD, MPH         
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Contact: David J Kolko, PhD    412-246-5888    kolkodj@upmc.edu   
Principal Investigator: David J Kolko, PhD         
Sub-Investigator: Satish Iyengar, PhD         
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
American Academy of Pediatrics
Drexel University
NYU Langone Health
University of Michigan
Investigators
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Principal Investigator: David J Kolko, PhD University of Pittsburgh
Publications:

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Responsible Party: David Kolko, Professor of Psychiatry, Psychology, Pediatrics, and Clinical and Translational Science, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04946253    
Other Study ID Numbers: STUDY20080207
R01MH124914 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case data, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. Study investigators/study staff will upload descriptive/raw data to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis. Data will be released to NDCT after manuscripts reporting primary findings are accepted for publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication. The investigators plan to make these data available indefinitely, with no anticipated time limit.
Access Criteria: In addition to public access to the NDCT, data can also be accessed by contacting the principal investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Kolko, University of Pittsburgh:
Oppositional Defiant Disorder
Attention Deficit Hyperactivity Disorder
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Behavioral Symptoms