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Family Navigation to Improve ADHD Treatment Adherence for Minority Children
NCT04591951 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04591951
The ClinicalTrials.gov registry entry for NCT04591951 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 715 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04591951 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04591951?
The interventions under investigation include: Usual care (OTHER), I2-ART (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04591951?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 715 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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