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

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment DOCC for disruptive behavior and ADHD?

Research shows that the Doctor Office Collaborative Care (DOCC) model is effective for managing behavior problems and ADHD in children, as it has been demonstrated to improve outcomes compared to usual care. Additionally, it may help reduce mental health care costs for children. ^{1 2 3 4 5}

Is the Doctor Office Collaborative Care (DOCC) model safe for treating disruptive behaviors in children?

The available research does not specifically address the safety of the DOCC model, but it is a collaborative care approach used in primary care settings, which generally suggests it is considered safe for managing pediatric behavior problems and ADHD. ^{1 3 5 6 7}

How is the DOCC treatment for disruptive behavior and ADHD different from other treatments?

The DOCC treatment is unique because it involves a collaborative care approach where healthcare providers work closely with families and schools to manage disruptive behaviors and ADHD, focusing on real-world implementation and engagement strategies to overcome practical barriers like scheduling and transportation. ^{8 9 10 11 12}

Research Team

David J Kolko, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Collaborative care outcomes for pediatric behavioral health problems: a cluster randomized trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Training Platform for School Clinicians in Evidence-Based Practices for ADHD. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Collaborative mental health care for pediatric behavior disorders in primary care: Does it reduce mental health care costs? [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Doctor-office collaborative care for pediatric behavioral problems: a preliminary clinical trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Targeted child psychiatric services: a new model of pediatric primary clinician--child psychiatry collaborative care. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Treatment of aggressive ADHD in children and adolescents: conceptualization and treatment of comorbid behavior disorders. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Follow-up care of children identified with ADHD by primary care clinicians: A prospective cohort study. [2018]

8. United States 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. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Case Management as a Significant Component of Usual Care Psychotherapy for Youth with Disruptive Behavior Problems. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Stakeholder-Generated Implementation Strategies to Promote Evidence-Based ADHD Treatment in Community Mental Health. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Clinician-Identified Factors in Success of Parent-Directed Behavioral Therapy for Children's Tantrums. [2022]