Family Navigation to Improve ADHD Treatment Adherence for Minority Children
Running, not enrolling · Not applicable
Conditions studied: Attention Deficit Hyperactivity Disorder
In brief
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.
Key facts
- Study ID
- NCT04591951
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 108
- Starts
- 2021-05-14
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2026-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Currently providing care for children with ADHD as psychologists, general pediatricians, or developmental pediatricians.
- > 18 years old.
- Any race/ethnicity.
You may not qualify if…
- Unable to read/speak either English or Spanish.
- Family navigators.
- Inclusion Criteria:
- Having experience working as family navigator and/or community health worker.
- Latinx (Lx) or African American (AA).
- > 18 years old.
- Exclusion Criteria:
- Unable to read/speak either English or Spanish.
- Caregivers.
- Inclusion Criteria:
- Phase 1a: current or former caregiver of a child with ADHD, with and without experience with ADHD treatment.
- Phases 1b and 2: current caregiver of a child (aged 7-11 years) with ADHD who is ADHD treatment-naïve at study enrollment.
- Lx or AA.
- > 18 years old.
- Exclusion Criteria:
- Unable to read/speak either English or Spanish.
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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