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NCT04591951 · ClinicalTrials.gov registry record · NA
Family Navigation to Improve ADHD Treatment Adherence for Minority Children
A NA study of Attention Deficit Hyperactivity Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- NA
- Development phase
- 108
- Enrollment target
- 1
- Study location
NCT04591951: Active NA study of Attention Deficit Hyperactivity Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04591951 is a NA study of Attention Deficit Hyperactivity Disorder that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 108 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04591951, a NA study of Attention Deficit Hyperactivity Disorder, is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The family navigators will record the number of sessions attended by caregivers.
Conditions Studied
Interventions
- OTHER Usual care
- BEHAVIORAL I2-ART
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2021-05-14 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
What the registry record for NCT04591951 still lists
NCT04591951 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Usual care is the first listed.
NCT04591951 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04591951 about?
NCT04591951 is a clinical study titled "Family Navigation to Improve ADHD Treatment Adherence for Minority Children". 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 effective...
What is the current status of trial NCT04591951?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 108 participants. The study started on 2021-05-14. Estimated completion is 2026-04-30.
What conditions does trial NCT04591951 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT04591951?
The interventions under investigation include: Usual care (OTHER), I2-ART (BEHAVIORAL).
Who is sponsoring clinical trial NCT04591951?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04591951 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04591951's enrollment target sits among peer trials
108 44th of 102 higher than 59 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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