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NCT05835362 · ClinicalTrials.gov registry record · NA
Improving the Outcomes of Adolescents With ADHD Via a Pre-visit Question Prompt List/Video Intervention
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 252
- Enrollment target
NCT05835362 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 252 participants.
The verdict
NCT05835362, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 252 participants
- Enrollment target
Study Summary
The investigators propose to conduct a pilot randomized controlled feasibility trial to evaluate the feasibility and effectiveness of a pre-visit intervention to improve communication about attention deficit hyperactivity disorder. The investigators will enroll 140 English-speaking youth ages 11-17 with an ADHD medical record diagnosis who screen as having predominantly inattentive subtype, hyperactive/impulsive subtype, or combined inattention/hyperactivity on the Vanderbilt parent assessment scale from three pediatric clinics. The investigators will randomize the families to receive both the question prompt lists and video (N=35), just the question prompt lists (N=35), just the video (N=35), or usual care (N=35). This will allow the team to understand whether both the video and question prompt list components are needed for the larger trial. The aims of the investigators are: Aim 1: To examine whether the ADHD question prompt lists and/or pre-visit video significantly impact the proposed mechanisms of the intervention. The team will investigate whether adolescents and parents in each of the intervention groups: (a) ask more questions and receive more provider education about ADHD during their baseline and 3-month visits and (b) have higher self-efficacy at 3 and 6 months than adolescents and parents in the usual care group. Aim 2: To investigate the effectiveness of the ADHD question prompt lists and/or the pre-visit video by examining whether adolescents in each of the intervention groups have improved ADHD symptoms, school and social performance, and quality-of-life at 6 months compared to those in the usual care group. Aim 3: To assess adolescent and parent feedback on the acceptability, feasibility, tolerability, and safety of using the ADHD question prompt lists and/or the pre-visit video. The results from this pilot trial will be used to inform a larger trial by: (a) identifying the intervention arm with the greatest potential impact, acceptability, feasi
Interventions
- BEHAVIORAL Question Prompt List
- BEHAVIORAL Video Only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2023-03-22 |
| Est. Completion | 2025-11-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05835362
The ClinicalTrials.gov registry entry for NCT05835362 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Question Prompt List is the first listed.
NCT05835362 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05835362 about?
NCT05835362 is a clinical study titled "Improving the Outcomes of Adolescents With ADHD Via a Pre-visit Question Prompt List/Video Intervention". The investigators propose to conduct a pilot randomized controlled feasibility trial to evaluate the feasibility and effectiveness of a pre-visit intervention to improve communication about attention deficit hyperactivity disorder. The investigators will enroll 140 English-speaking youth ages 11-17 ...
What is the current status of trial NCT05835362?
This trial is currently completed. It is a NA study. The enrollment target is 252 participants. The study started on 2023-03-22. Estimated completion is 2025-11-30.
What interventions are being tested in trial NCT05835362?
The interventions under investigation include: Question Prompt List (BEHAVIORAL), Video Only (BEHAVIORAL).
Who is sponsoring clinical trial NCT05835362?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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