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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)
Awards & highlights

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 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."

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
827 Previous Clinical Trials
6,564,339 Total Patients Enrolled
33 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
3,965 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Kelly Kamimura-Nishimura, MDPrincipal Investigator - Children's Hospital Medical Center, Cincinnati
Cincinnati Children's Hospital Medical Center, Convalescent Hospital for Children

Media Library

I2-ART Clinical Trial Eligibility Overview. Trial Name: NCT04591951 — N/A
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: I2-ART Group, Control Group
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: I2-ART Highlights & Side Effects. Trial Name: NCT04591951 — N/A
I2-ART 2023 Treatment Timeline for Medical Study. Trial Name: NCT04591951 — N/A
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT04591951 — N/A
~25 spots leftby Sep 2025
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