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Family Navigation for ADHD Treatment Adherence (I2-ART Trial)

N/A

Recruiting

Led By Kelly Kamimura-Nishimura, MD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

> 18 years old.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months)

Summary

This trial is testing a new intervention to improve treatment adherence in minority children with ADHD. The intervention will be compared to usual care to see if it is more effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on an intervention to improve adherence rather than a medication or medical procedure, it does not directly involve side effects related to drugs or invasive treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after first session (up to 1 week), after intervention session (up to 1 month), after third session (up to 2 months), immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after first session (up to 1 week), after intervention session (up to 1 month), after third session (up to 2 months), immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after first session (up to 1 week), after intervention session (up to 1 month), after third session (up to 2 months), immediately after intervention (up to 3 months), 3 months after intervention (up to 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ADHD medication initiation 3 months after intervention

ADHD medication initiation immediately after intervention

Behavior Therapy Disengagement 3 months after intervention

+18 more

Secondary study objectives

Change in Vanderbilt ADHD Parent Report Scale Scores from baseline to 3 months after intervention

Other study objectives

Beliefs about Medicines Questionnaire

Brief Illness Perceptions Questionnaire

Caregivers' Educational Level

+10 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: I2-ART GroupActive Control1 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 GroupPlacebo Group1 Intervention

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

0 / 1Eligibility criteria met