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

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

Conditions

• ADHD

Interventions

BEHAVIORAL

Question prompt list

A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level.

BEHAVIORAL

Pre-visit video

The 11-minute video has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD.

BEHAVIORAL

Combined question prompt list/video

A question prompt list is a list of questions about ADHD (one page) given to study participants to select questions they may want to ask the provider. The youth question prompt list contains 22 questions, and the parent question prompt list contains 20 questions. Both are below a fourth-grade reading level. And the video is an 11-minute video that has six themes: (a) talking to your doctor about ADHD, (b) controlling ADHD without medicine, (c) ADHD medications, (d) ADHD and school, (e) ADHD and your relationships, and (f) helping your parents understand your ADHD.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Betsy Sleath, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-22

Primary Completion

2025-11-30

Completion

2025-11-30

Countries

• United States

Study Locations