Improving the Outcomes of Adolescents With ADHD Via a Pre-visit Question Prompt List/Video Intervention

Completed · Not applicable

Conditions studied: ADHD

In brief

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, feasibility, and tolerability, and (b) determine the best mechanisms and outcome variables to assess in a larger trial.

Key facts

Study ID

NCT05835362

Run by

University of North Carolina, Chapel Hill

People needed

252

Starts

2023-03-22

Expected to finish

2025-11-30

Last updated by the study team

2026-07-02

Who can join

Age: 11 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Youth eligibility criteria are: age 11 to 17 years, speak and read English, have an ADHD diagnosis, are present for an ADHD visit, and screen as having predominantly inattentive subtype, hyperactive/impulsive subtype, or combined inattention/hyperactivity on the Vanderbilt parent assessment scale. Youth's parents will be eligible if they are at least 18 years of age, speak and read English, and are the legal guardian of the child.

You may not qualify if…

• Child does not have ADHD.
• Child is not between the ages of 11 and 17.
• Child does not see a provider at the clinic who is participating in the study.
• Child does not speak English.
• Child/parent does not want to have today's medical visit audio-recorded.
• Parent under 18 years of age, do not speak and read English, and are not the legal guardian of the adolescent.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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