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NCT04473755 · ClinicalTrials.gov registry record
A Naturalistic Study of Functional Impairment for Individuals With ADHD in the Early Morning and Late Afternoon/Evening Hours
A clinical trial, sponsored by Florida International University.
- Completed
- Registry status
- 60
- Enrollment target
NCT04473755: Completed study, sponsored by Florida International University.
NCT04473755 is a clinical trial that has completed, run by Florida International University. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04473755 has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
Study Summary
The objective of this study is to assess the burden and impact of ADHD impairment in the early morning and late afternoon/evening hours for adolescents and young adults. Functional impairments will focus on the currently identified areas of functional impairment in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric Association, 2013) - namely, social, academic, and occupational functioning. This is necessary for two reasons: (1) the current literature on ADHD impairment and functioning is concentrated within elementary school children; and (2) studies of intervention effectiveness are typically concentrated during the school day. This current state of the literature ignores the obvious - as ADHD is a chronic disorder, it needs to be addressed as children grow into adolescence and young adulthood, and it needs to be remediated at times outside of the school day such as in the morning and late afternoon/evening. Therefore, the specific areas assessed in the present study will relate to driving, school, work, and family functioning. These are important areas to study, as the research literature has typically focused on elementary school and school-day behavior in assessments of symptom presentation, impairment, and treatment outcome. As individuals with ADHD grow older, the entire day becomes relevant in determinations of functioning (e.g., workdays may begin in the very early morning or last into the evening/night), and productivity can be assessed across waking hours rather than just across the elementary school day. Once areas of functional impairment in these times of day are determined, for this age group, treatment candidates can aim to address these treatment targets.
Primary Outcome
Ecological, momentary assessment of social interaction impairment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-08-04 |
| Est. Completion | 2020-12-31 |
What the finished NCT04473755 record still lists
NCT04473755 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04473755 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04473755 about?
NCT04473755 is a clinical study titled "A Naturalistic Study of Functional Impairment for Individuals With ADHD in the Early Morning and Late Afternoon/Evening Hours". The objective of this study is to assess the burden and impact of ADHD impairment in the early morning and late afternoon/evening hours for adolescents and young adults. Functional impairments will focus on the currently identified areas of functional impairment in the Diagnostic and Statistical Man...
What is the current status of trial NCT04473755?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2020-08-04. Estimated completion is 2020-12-31.
Who is sponsoring clinical trial NCT04473755?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
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