Family Navigation for ADHD Treatment Adherence

(I2-ART Trial)

Overseen By Kelly Kamimura-Nishimura

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Non-English/Spanish speakers

Compensation: Varies

Number of Visits: 26

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called I2-ART (Individualized Intervention to Address Racial/Ethnic Treatment Adherence Disparities in ADHD) to help families maintain ADHD treatments for their children. It focuses on improving treatment adherence in Latinx and African American children with ADHD, who often encounter barriers such as distrust of the healthcare system and access issues. The trial will determine if I2-ART, which includes educational sessions and personal support, proves more effective than usual care. Caregivers of children aged 7-11 with ADHD who have not yet started treatment are eligible to participate. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance ADHD treatment adherence in diverse communities.

Will I have to stop taking my current medications?

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

What prior data suggests that the I2-ART intervention is safe for improving ADHD treatment adherence?

Research has shown that the I2-ART program is designed to help families better adhere to ADHD treatments. As this trial is just beginning, it focuses on developing and refining the I2-ART program. Consequently, there is limited information on its health effects. However, since it involves training and support sessions rather than medication, it is generally considered low-risk. In studies like this, the primary concern is whether participants find the program beneficial and if it aids in maintaining their ADHD treatment. Similar programs have not reported any harmful effects in the past. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I2-ART intervention because it offers a fresh approach to improving ADHD treatment adherence by empowering caregivers. Unlike standard treatments that focus primarily on medication and behavior therapy for the child, I2-ART equips caregivers with skills like listening, engagement, and boundary-setting, alongside comprehensive ADHD education. This intervention is unique because it involves interactive sessions and personalized support from family navigators, fostering a more informed and supported caregiving environment. By enhancing caregivers' understanding and involvement, I2-ART aims to improve adherence to ADHD treatments and overall outcomes for children.

What evidence suggests that the I2-ART intervention is effective for improving ADHD treatment adherence?

Research has shown that the I2-ART program, which participants in this trial may receive, might help children with ADHD adhere to their treatment plans, particularly in minority families. Early results suggest that addressing challenges such as distrust of the healthcare system and limited access to mental health services can enhance treatment adherence in children. Studies have found that support and education for families improve ADHD management. I2-ART offers information and practical assistance through family guides, aiming to empower caregivers and ensure consistent treatment. This method draws inspiration from successful programs that use group support and skill-building to enhance treatment adherence. ^{1 2 3 4 6}

Who Is on the Research Team?

Kelly Kamimura-Nishimura, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for caregivers of children aged 7-11 with ADHD who haven't started treatment yet, focusing on Latinx and African American communities. It's also for clinicians and family navigators over 18 years old, regardless of race/ethnicity. Participants must be able to read/speak English or Spanish.

Inclusion Criteria

I am over 18 years old.

Some health professionals who currently treat children with ADHD are psychologists, general pediatricians, or developmental pediatricians.

This exclusion criterion seems incomplete and does not provide enough information. Please provide more details or context.

Exclusion Criteria

Unable to read/speak either English or Spanish.

Timeline for a Trial Participant

Phase 1a: Focus Groups

Conduct focus groups with stakeholders to identify and develop I2-ART's basic elements.

9 months

8 focus group sessions

Phase 1b: Training and Implementation

Train family navigators and implement I2-ART with caregivers to assess feasibility and acceptability.

12 months

3 months of training, followed by 3 months of intervention with multiple meetings

Phase 2: Evaluation of Efficacy

Evaluate the preliminary effectiveness of the revised I2-ART intervention compared to usual care.

24 months

Two waves of intervention, each lasting 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment.

3 months

Post-intervention assessments at 3 months

What Are the Treatments Tested in This Trial?

Interventions

• I2-ART
• Usual care

Trial Overview The study tests the I2-ART intervention aimed at improving treatment adherence in minority children with ADHD compared to usual care. The process includes focus groups, training family navigators, and evaluating the intervention's preliminary efficacy through different phases.

How Is the Trial Designed?

Group I: I2-ART Group Active Control 1 Intervention

I2-ART intervention will be modeled based on the Parent Empowerment Program model. It will use methods of adult learning, direct instruction to share knowledge or techniques for practice, group support, modeling, vicarious learning, and practice opportunities (i.e., role rehearsals). I2-ART training includes 40 hours of didactic and interactive sessions (10 sessions of 4 hours each) covering the following areas: 1) conceptual framework, 2) listening, engagement, and boundary-setting skills; 3) ADHD psychoeducation (e.g., diagnosis, treatment, shared decision-making tools), and 4) service options. The caregivers in the I2-ART group will receive the intervention for 3 months. The I2-ART will be implemented by the family navigators and will include a 2-hour face-to-face meeting, at least three monthly in-person meetings, and intermittent contact between in-person meetings by phone calls, texts or emails, as determined by the family navigator-caregiver dyad.

Group II: Control Group Placebo Group 1 Intervention

The caregivers in the control group will receive "usual care."

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

A study using Medicaid data from 2014-2016 found that 97% of children with good medication adherence (PDC≥0.7) met the HEDIS C&M follow-up criteria, indicating a strong link between adherence and follow-up care.

In contrast, children with poor adherence (PDC<0.7) did not meet the follow-up criteria, suggesting that the HEDIS C&M phase follow-up measure may not effectively capture the needs of all children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of the Healthcare Effectiveness Data and Information Set (HEDIS) Follow-Up Care Measures and Medication Adherence Among Medicaid Insured Children with ADHD. Earla, JR., Abughosh, S., Chen, H.[2022]

A study involving 26 participants from focus groups and interviews revealed that minoritized children face significant barriers to ADHD treatment initiation and adherence, including lack of support from schools and healthcare, cultural barriers, and limited resources.

Facilitators for successful ADHD treatment included caregivers' prior experience with ADHD, strong support systems, and access to resources, highlighting the need for culturally tailored interventions to improve treatment outcomes for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Barriers and Facilitators of Attention-Deficit/Hyperactivity Disorder Treatment Initiation and Adherence in Black and Latinx Children. Kamimura-Nishimura, K., Bush, H., Amaya de Lopez, P., et al.[2023]

A study involving 41 parents of children with ADHD revealed a six-stage process for engaging in treatment, highlighting barriers such as fear, stigma, and communication issues that can hinder progress through these stages.

The findings suggest that understanding these stages can help develop targeted interventions to improve treatment engagement, especially for socioeconomically disadvantaged and minority families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six Stages of Engagement in ADHD Treatment Described by Diverse, Urban Parents. Spencer, AE., Sikov, J., Loubeau, JK., et al.[2023]

In a study of 1,068 pediatric patients with ADHD, 64.5% were found to be adherent to their medication, with non-adherence being particularly high in East Asia (55.5%).

Non-adherence was linked to poorer treatment responses and less improvement in ADHD symptoms, highlighting the importance of addressing adherence issues to enhance clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and consequences of adherence to the treatment of pediatric patients with attention-deficit/hyperactivity disorder in Central Europe and East Asia. Hong, J., Novick, D., Treuer, T., et al.[2022]

Non-adherence to treatment regimens for ADHD in pediatric populations can range from 15% to 87%, indicating a significant challenge in achieving effective management of the condition.

Factors that improve adherence include using long-acting medication formulations and addressing comorbidities, while challenges such as multiple daily dosing and adverse effects can lead to decreased adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention-deficit/hyperactivity disorder: an update on medication adherence and persistence in children, adolescents and adults. Ahmed, R., Aslani, P.[2013]

A study on adolescents and young adults with ADHD identified key factors leading to medication non-adherence, including being White, forgetting to take medication, disliking the medication's effects, and wanting a 'tolerance break.'

Notably, one in five participants reported wanting a tolerance break as a reason for not adhering to their medication, highlighting the need for further research into this phenomenon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Non-Adherence and Tolerance Breaks Among Adolescents and Young Adults With ADHD. Barnard-Brak, L., Marques, A., Kudesey, C.[2023]

Citations

1. grantome.com grantome.com/grant/NIH/K23-MH125138-01

A Family Navigator Intervention to Improve ADHD This study aims to develop and test the I2-ART intervention to improve treatment adherence in minority (Latinx and African American) children with ADHD. The ...

2. withpower.com withpower.com/trial/phase-attention-deficit-disorder-with-hyperactivity-4-2021-6c263

Family Navigation for ADHD Treatment Adherence I2-ART is unique because it focuses on improving treatment adherence among racial and ethnic minority families by addressing specific barriers they face, rather ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524141/

Understanding Barriers and Facilitators of ADHD ... The goal of this study was to explore barriers and facilitators to ADHD treatment initiation/adherence for minoritized children.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876285923001018

Understanding Barriers and Facilitators of Attention-Deficit ... The results from this study have the potential to improve ADHD treatment initiation/adherence and outcomes for minoritized children through the development ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04082234

Reducing Disparities in Behavioral Health Treatment for ... The primary outcomes are patient-centered outcomes pertaining to child academic achievement, behavior compliance, interpersonal relationships, and life ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35959536/

Racial and Ethnic Disparities in Childhood ADHD Treatment ... The study examined racial-ethnic disparities in access to and utilization of treatment for attention-deficit hyperactivity disorder (ADHD) and other ...