Implementation Support Strategies for Disruptive Behaviors

(SKIPforPA Trial)

Recruiting at 1 trial location

Overseen By Satish Iyengar, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Already enrolled caregiver

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests strategies to improve the use of a treatment for childhood disruptive behaviors and ADHD in pediatric primary care offices. The treatment, known as Doctor Office Collaborative Care (DOCC), has already shown positive results in managing these issues. The trial will compare different ways to implement DOCC, such as providing extra support to practice leaders or care teams, to determine the most effective approach. Caregivers of children aged 5-12 with noticeable behavior problems would be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies that could enhance care for children with behavioral challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Doctor Office Collaborative Care (DOCC) safely manages childhood behavior issues and ADHD. Studies have found that DOCC results in a high number of children starting and completing treatment. Specifically, 99.4% of children began treatment, and 76.6% completed it, indicating the treatment's positive reception.

Moreover, DOCC has led to significant improvements in children's behavior and emotions, underscoring its effectiveness and safety. No major reports of negative side effects have emerged, making it a promising option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they aim to enhance the implementation of DOCC, an evidence-based approach for managing disruptive behavior and ADHD. Unlike typical treatments that may lack structured support post-training, these strategies provide targeted support for practice leadership (LEAD) and care teams (TEAM), potentially increasing effectiveness. By providing tailored implementation support, these treatments might improve how DOCC is adopted and sustained in clinical settings, leading to better patient outcomes.

What evidence suggests that this trial's treatments could be effective for managing disruptive behavior and ADHD?

Research has shown that the Doctor Office Collaborative Care (DOCC) model effectively manages childhood behavior problems and ADHD. Studies have found that children are more likely to start and complete treatment with DOCC compared to regular care—99.4% start with DOCC versus 54.2% with usual care, and 76.6% complete treatment with DOCC versus 11.6% with usual care. DOCC also reduces oppositional behaviors and improves symptoms of oppositional defiant disorder (ODD) and overall quality of life over time. This model involves both the child and parent in behavioral therapy, a proven method for addressing disruptive behavior issues. The consistent improvements in clinical outcomes demonstrate DOCC's effectiveness in these areas. In this trial, participants will receive DOCC with varying levels of implementation support, including standard implementation, TEAM implementation, LEAD implementation, or both TEAM and LEAD implementation, to assess the impact of these support strategies on the effectiveness of DOCC. ^{1 2 5 6 7}

Who Is on the Research Team?

David J Kolko, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

I am a Practice Manager at a pediatric care practice selected for the study.

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

Exclusion Criteria

Caregivers: Already enrolled in the study as the caregiver to a different child (e.g., sibling)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Standard training in the DOCC evidence-based practice (EBP) for all practices

4 weeks

Implementation

Implementation of DOCC with various support strategies (TEAM, LEAD, or both) delivered via videoconference

24 months

Regular videoconference sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• DOCC: Evidence-based treatment for disruptive behavior and ADHD
• Implementation support strategies at the leadership level following standard implementation of DOCC
• TEAM: Implementation support strategies at the care team level following standard implementation of DOCC

Trial Overview 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.

How Is the Trial Designed?

Group I: DOCC with TEAM implementation Experimental Treatment 2 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 implementation Experimental Treatment 3 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 implementation Experimental Treatment 2 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 Control 1 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.

DOCC: Evidence-based treatment for disruptive behavior and ADHD is already approved in United States for the following indications:

Approved in United States as DOCC for:

• Disruptive behavior
• Attention-deficit/hyperactivity disorder (ADHD)

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Pennsylvania American Academy of Pediatrics

Collaborator

Trials

2

Recruited

480+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Pennsylvania Chapter American Academy of Pediatrics

Collaborator

Trials

1

Recruited

450+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

American Academy of Pediatrics

Collaborator

Trials

46

Recruited

4,071,000+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

Published Research Related to This Trial

This study aims to improve the implementation of an evidence-based practice for treating Oppositional Defiant Disorder (ODD) in children, particularly in public mental health clinics serving low-income communities, involving 134 clinics and nearly 2700 caregiver/child pairs.

The research will assess how a Clinic Implementation Team (CIT) can enhance the uptake and long-term use of the 4Rs and 2Ss Multiple Family Group intervention, potentially increasing access to effective treatments for children with ODD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial. Acri, M., Hamovitch, E., Mini, M., et al.[2019]

Clinicians believe that the success of parent-directed behavioral therapy (PDT) for disruptive behavior disorders in children is significantly influenced by appointment attendance and the primary caregiver's commitment to the treatment approach.

Additional factors affecting PDT effectiveness include the caregiver's support system, emotional and physical well-being, the complexity of the child's behavior, and the home environment, suggesting that improving these areas could enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician-Identified Factors in Success of Parent-Directed Behavioral Therapy for Children's Tantrums. Yu-Lefler, HF., Lindauer, S., Riley, AW.[2022]

In a study of 659 families with children diagnosed with ADHD, it was found that children had a median of only one follow-up visit with their primary care clinician over six months, indicating a need for more consistent follow-up care.

Only 26% of children saw a mental health specialist, highlighting a gap in specialized care, although those with certain demographics, like being black or on Medicaid, were more likely to receive this support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up care of children identified with ADHD by primary care clinicians: A prospective cohort study. Gardner, W., Kelleher, KJ., Pajer, K., et al.[2018]

Case management (CM) is commonly utilized in usual care psychotherapy for youth with disruptive behavior problems (DBPs), indicating its importance in coordinating care among various service providers.

The frequent use of CM in usual care suggests that it may play a significant role in the implementation of evidence-based practices for treating youth with DBPs, potentially impacting their treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Management as a Significant Component of Usual Care Psychotherapy for Youth with Disruptive Behavior Problems. Zoffness, R., Garland, A., Brookman-Frazee, L., et al.[2021]

The doctor-office collaborative care (DOCC) model was found to be effective for treating pediatric behavior problems and ADHD, showing improved clinical outcomes compared to enhanced usual care (EUC) in a randomized controlled trial with 321 child participants over a 6-month period.

While the DOCC model had higher initial intervention costs, it resulted in lower overall costs for community mental health services during and shortly after the intervention, suggesting potential cost savings alongside improved treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative mental health care for pediatric behavior disorders in primary care: Does it reduce mental health care costs? Yu, H., Kolko, DJ., Torres, E.[2018]

The Targeted Child Psychiatric Services (TCPS) model offers a collaborative approach between pediatric primary care clinicians and child psychiatrists, addressing the significant need for mental health support among children and adolescents, who often face behavioral health disorders.

Over the first 18 months of the program, TCPS has effectively supported numerous pediatric practices in evaluating and treating complex conditions like ADHD, depression, and anxiety, highlighting its potential to improve access to mental health care in primary settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted child psychiatric services: a new model of pediatric primary clinician--child psychiatry collaborative care. Connor, DF., McLaughlin, TJ., Jeffers-Terry, M., et al.[2018]

A new web-based training platform for school clinicians was developed to enhance their skills in evidence-based practices for treating youth with ADHD, showing high usability and clinician satisfaction.

The outcomes for students trained by clinicians using this remote platform were comparable to those achieved through traditional in-person training, indicating that online training can effectively disseminate evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Training Platform for School Clinicians in Evidence-Based Practices for ADHD. Pfiffner, LJ., Dvorsky, MR., Friedman, LM., et al.[2023]

The integrated mental health intervention, doctor-office collaborative care (DOCC), showed significant improvements in service use, behavioral and emotional problems, and overall clinical response compared to enhanced usual care (EUC) in a study involving 78 children aged 5-12 years.

Parents and pediatricians reported high satisfaction with the DOCC model, indicating its feasibility and effectiveness in addressing common mental health issues in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doctor-office collaborative care for pediatric behavioral problems: a preliminary clinical trial. Kolko, DJ., Campo, JV., Kilbourne, AM., et al.[2023]

A study involving 26 agency staff and 452 parents and youth identified key barriers to implementing the STAND program for ADHD, including practical issues like transportation and scheduling, as well as the need for better engagement with parents and youth.

Eighteen effective implementation strategies were proposed, focusing on training stakeholders, engaging consumers, providing interactive assistance, and using evaluative methods, which will be tested in a pilot trial to improve the STAND service delivery model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder-Generated Implementation Strategies to Promote Evidence-Based ADHD Treatment in Community Mental Health. Sibley, MH., Ortiz, M., Rios-Davis, A., et al.[2022]

A systematic review of 29 clinical practice guidelines (CPGs) for managing disruptive behaviors in children and youth found that only three guidelines met high-quality standards, indicating a need for improved methodological rigor in developing these guidelines.

The majority of guidelines focused on ADHD, with two high-quality guidelines from NICE and the Spanish Ministry of Health, highlighting the importance of evidence-based practices in effectively addressing ADHD and conduct disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review and Evaluation of Clinical Practice Guidelines for Children and Youth with Disruptive Behavior: Rigor of Development and Recommendations for Use. Andrade, BF., Courtney, D., Duda, S., et al.[2020]

About 50% of patients with ADHD also have oppositional defiant disorder (ODD), and up to 20% may have conduct disorder (CD), indicating a high rate of comorbidity that primary care physicians should be aware of.

Primary care physicians feel more confident managing ADHD alone compared to ADHD with comorbid ODD or CD, suggesting a need for additional training or support to effectively handle these more complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of aggressive ADHD in children and adolescents: conceptualization and treatment of comorbid behavior disorders. McBurnett, K., Pfiffner, LJ.[2015]

The Doctor Office Collaborative Care (DOCC) model significantly improved treatment initiation and completion rates for children with behavior problems, ADHD, and anxiety, with 99.4% starting treatment compared to 54.2% in enhanced usual care (EUC).

DOCC also led to notable improvements in behavior issues, parental stress, and overall family satisfaction, demonstrating its effectiveness in pediatric primary care settings over a 6-month intervention period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care outcomes for pediatric behavioral health problems: a cluster randomized trial. Kolko, DJ., Campo, J., Kilbourne, AM., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3966503/

Collaborative Care Outcomes for Pediatric Behavioral ... DOCC (versus EUC) was associated with higher rates of treatment initiation (99.4% vs 54.2%; P < .001) and completion (76.6% vs 11.6%, P < .001), improvement in ...

2. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/1107717

Doctor-Office Collaborative Care for Pediatric Behavioral ... Improvements in clinical outcomes were found for both conditions, but DOCC showed significantly greater reductions in oppositionality, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00600470?tab=table

Effectiveness of Collaborative Services in Primary Care for ... Behavioral therapy that targets parent and child skills has shown to be the most effective treatment for DBP. This study will evaluate the effectiveness of a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7444430/

Effects of Collaborative Care for Comorbid Attention Deficit ... Point-in-time contrasts showed that DOCC cases showed significant improvement in ODD symptoms and quality of life at 12 months and at 18 months; DOCC cases only ...

5. withpower.com withpower.com/trial/phase-attention-deficit-disorder-with-hyperactivity-8-2021-2eb6f

Implementation Support Strategies for Disruptive Behaviors The doctor-office collaborative care (DOCC) model was found to be effective for treating pediatric behavior problems and ADHD, showing improved clinical ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04946253

NCT04946253 | SKIP for PA Study: Team and Leadership ... The treatment investigators seek to deliver here is called Doctor Office Collaborative Care (DOCC), an evidence-based intervention for the management of child ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22064876/

Doctor-office collaborative care for pediatric behavioral ... Results: Group comparisons found significant improvements for DOCC over EUC in service use and completion, behavioral and emotional problems, individualized ...