I2-ART Group for Attention Deficit Hyperactivity Disorder (ADHD)

Cincinnati Children's Hospital Medical Center, Cincinnati, OH
I2-ART +1 moreN/ARecruitingLed by Kelly Kamimura-Nishimura, MDResearch Sponsored by Children's Hospital Medical Center, Cincinnati

Study 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.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after intervention, up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after intervention, up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ADHD medication initiation 3 months after intervention
ADHD medication initiation immediately after intervention
Behavior Therapy Disengagement 3 months after intervention
+18 more
Secondary outcome measures
Change in Vanderbilt ADHD Parent Report Scale Scores from baseline to 3 months after intervention
Other outcome measures
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 site

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
784 Previous Clinical Trials
5,518,359 Total Patients Enrolled
31 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
3,889 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on how many participants are allowed for this trial?

"Affirmative, the clinicaltrials.gov site attests that this research project is in need of enrollees. It was initially posted on May 14th 2021 and has recently been updated on August 6th 2021. The study requires 108 individuals to be recruited at a single medical facility."

Answered by AI

Are there any individuals who are eligible to participate in this trial at the present moment?

"Based on the details provided by clinicaltrials.gov, this study is in search of recruits and has been since it was first published on May 14th 2021. The information there was most recently refreshed as of August 6th 2021."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
Cincinnati Children's Hospital Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I’m 22 years old and have just recently gotten diagnosed with ADHD. I feel it’s not being taking seriously in women, but in general of all people I feel like ADHD is not understood. Any trials that I can be apart of to help find more information and make dealing with ADHD easier, I want to at least try to be apart of!
~26 spots leftby Jul 2024