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Implementation Support Strategies for Disruptive Behaviors (SKIPforPA Trial)
N/A
Recruiting
Led By David J Kolko, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after caregiver baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether team- and practice leadership-level implementation strategies can help increase the use and uptake of a chronic care model-based intervention in diverse pediatric primary care offices.
Who is the study for?
This trial is for caregivers with a child aged 5-12 showing behavior problems, and staff at selected pediatric practices in PA. Staff roles include primary care providers, care managers, medical directors/senior leaders, and practice managers.
What is being tested?
The study tests if extra support strategies for teams and leadership can improve the use of DOCC—an effective treatment program for childhood behavior issues and ADHD—in various pediatric offices.
What are the potential side effects?
Since this trial focuses on implementation strategies rather than medications or direct treatments, it does not have typical side effects like those associated with drugs or medical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a Practice Manager at a pediatric care practice selected for the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after teacher baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after teacher baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Care management competencies and functions
Change from baseline in Pediatric Health Quality at 12 months
Change from baseline in Pediatric Health Quality at 3 months
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: DOCC with TEAM implementationExperimental Treatment2 Interventions
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).
Group II: DOCC with TEAM + LEAD implementationExperimental Treatment3 Interventions
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).
Group III: DOCC with LEAD implementationExperimental Treatment2 Interventions
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).
Group IV: DOCC with standard implementation (No TEAM or LEAD)Active Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Pennsylvania American Academy of PediatricsUNKNOWN
1 Previous Clinical Trials
26 Total Patients Enrolled
NYU Langone HealthOTHER
1,415 Previous Clinical Trials
855,753 Total Patients Enrolled
12 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
658 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
University of MichiganOTHER
1,863 Previous Clinical Trials
6,441,123 Total Patients Enrolled
7 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,245 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Pennsylvania Chapter American Academy of PediatricsUNKNOWN
University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,536 Total Patients Enrolled
11 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,460 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Institute of Mental Health (NIMH)NIH
2,933 Previous Clinical Trials
2,741,028 Total Patients Enrolled
97 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
21,170 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
American Academy of PediatricsOTHER
44 Previous Clinical Trials
1,070,641 Total Patients Enrolled
Drexel UniversityOTHER
155 Previous Clinical Trials
47,772 Total Patients Enrolled
David J Kolko, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
254 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
254 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a caregiver and I am 18 years old or older.I am a Practice Manager at a pediatric care practice selected for the study.You work at one of the twenty-four (24) pediatric primary care practices listed by the PA Chapter of the American Academy of Pediatrics, and are one of four types of participants: primary care provider, care manager, medical director, or practice manager.I am over 18, have a child aged 5-12 with behavior issues, and I have parental rights.I work in pediatric care and help with behavioral health as identified by my practice.This exclusion criterion is incomplete and requires more information to provide an accurate summary. Please provide additional details.I have a child aged 5-12 with noticeable behavior issues.
Research Study Groups:
This trial has the following groups:- Group 1: DOCC with LEAD implementation
- Group 2: DOCC with TEAM + LEAD implementation
- Group 3: DOCC with standard implementation (No TEAM or LEAD)
- Group 4: DOCC with TEAM implementation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT04946253 — N/A