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

Trial Summary

What is the purpose of this trial?

ADHD is the most common pediatric neurodevelopmental disorder and is associated with significant long-term impairments. Current guidelines recommend stimulant medication and/or behavioral therapy as first-line treatments for ADHD. Despite evidence that consistent treatment is important for effectively managing ADHD symptoms, treatment adherence remains suboptimal and is especially problematic among minority children. Hypothesized reasons for racial/ethnic disparities in ADHD treatment include uncertainties about medication efficacy and side effects, distrust of the health care system, and decreased access to mental health services. 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 proposed study involves three ORBIT phases: During phase 1a, the investigators will conduct focus groups with key stakeholders (i.e., caregivers, clinicians, and family navigators, n=24) to identify and develop I2-ART's basic elements. Next, during phase 1b, the investigators will train four family navigators to implement I2-ART with caregivers of treatment-naïve children with ADHD (n=8-12) in order to determine feasibility and acceptability. In phase 2, the investigators will use phase 1b findings to modify I2-ART as needed, and then will evaluate the preliminary efficacy of the revised I2-ART (n=40), compared to the "usual care" control condition (n=20), on ADHD treatment adherence. The preliminary data collected during the proposed study will inform a subsequent R01 randomized controlled trial to examine I2-ART efficacy.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment I2-ART for ADHD?

Research highlights that adherence to ADHD treatment is often low, with rates ranging from 15% to 87%. Factors like long-acting medication forms and addressing comorbidities can improve adherence, suggesting that individualized interventions like I2-ART may help improve treatment adherence in diverse populations. ^{1 2 3 4 5}

How is the I2-ART treatment for ADHD different from other treatments?

I2-ART is unique because it focuses on improving treatment adherence among racial and ethnic minority families by addressing specific barriers they face, rather than just providing medication. This approach aims to enhance engagement and consistency in ADHD care, which is often a challenge in these communities. ^{2 3 4 5 6}

Research Team

Kelly Kamimura-Nishimura, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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 a healthcare provider for children with ADHD and am over 18.

I am over 18 and care for a child with ADHD, who may or may not have started treatment.

I am over 18, identify as Latinx or African American, and have experience as a family navigator or community health worker.

Exclusion Criteria

Unable to read/speak either English or Spanish.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

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

Medication Non-Adherence and Tolerance Breaks Among Adolescents and Young Adults With ADHD. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2022]

4. New Zealand 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. [2022]

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

Six Stages of Engagement in ADHD Treatment Described by Diverse, Urban Parents. [2023]

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

Understanding Barriers and Facilitators of Attention-Deficit/Hyperactivity Disorder Treatment Initiation and Adherence in Black and Latinx Children. [2023]