Improving the Outcomes of Adolescents With ADHD Via a Pre-visit Question Prompt List/Video Intervention
2 other identifiers
interventional
126
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2023
CompletedFirst Submitted
Initial submission to the registry
April 18, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedFebruary 24, 2026
February 1, 2026
2.7 years
April 18, 2023
February 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Vanderbilt Assessment Total Symptom Score (parent informant)
The Vanderbilt parent informant ADHD rating scales is a Diagnostic and Statistical Manual for Mental Disorders-IV-based scale, which give a Total Symptom Score. The Vanderbilt ADHD Rating Scale has been shown to have valid psychometric properties consistent with the Diagnostic and Statistical Manual for Mental Disorders; the Vanderbilt includes all the DSM-IV symptoms for ADHD. The Vanderbilt has demonstrated acceptable internal consistency, adequate factor structure, and good reliability and validity as a measure of youth behavior and school functioning. The Vanderbilt includes 18 DSM-IV symptoms that are rated on a 4-point Likert scale ranging from 0 to 3. The parent (primary outcome) Total Symptom Scores (TSS) will be calculated by summing the scores on each item; summary scores can range from 0 to 54. Higher scores indicate worse symptoms. The investigators will examine changes in the total symptom summary score from baseline to 6 months.
6 months
Youth functioning using the Vanderbilt Assessment (parent informant) Average Performance Score
The Vanderbilt average performance score (parent informant) has 8 functional impairment items (overall school performance, reading, writing, math, relationship with parents, relationship with siblings, relationship with peers, and participation in organized activities such as team sports) measured on a 5-point Likert scale (ranging from 1 to 5). A summary score will be calculated by summing the scores and dividing by the 8 items to calculate an average performance score. Higher scores indicate worse performance. The investigators will examine changes in the average performance score from baseline to 6 months.
6 months
Secondary Outcomes (1)
Pediatric Quality of Life Inventory (PedsQL)
6 months
Study Arms (4)
Question prompt list only group
EXPERIMENTALIn the question prompt list group youth will be handed the youth ADHD prompt list, and the parent will be handed the parent ADHD prompt list, and will be told, "Your provider wants you to ask any questions that you have about ADHD. Here are lists of questions that you may want to ask. Please spend some time reading through this and marking any questions you want to ask your provider during the visit. You can also write other questions you want to ask on the bottom."
Pre-visit video only group
EXPERIMENTALParents and youth in the pre-visit video only group will watch together a short educational video with six themes on an iPad encouraging families to ask questions and to be engaged during ADHD visits.
Combined question prompt list/video intervention group
EXPERIMENTALIn the combined pre-visit video/question prompt list group youth will watch the video with the parent. Then, youth will be handed the youth ADHD prompt list, and the parent will be handed the parent ADHD prompt list, and will be told, "Your provider wants you to ask any questions that you have about ADHD. Here are lists of questions that you may want to ask. Please spend some time reading through this and marking any questions you want to ask your provider during the visit. You can also write other questions you want to ask on the bottom."
Control group
NO INTERVENTIONThe control group will receive usual care.
Interventions
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.
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.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Betsy Sleath, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2023
First Posted
April 28, 2023
Study Start
March 22, 2023
Primary Completion
November 30, 2025
Study Completion
November 30, 2025
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Beginning 9 and continuing for 36 months following publication
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
De-identified individual data that supports the final trial results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. Because this is a vulnerable population only specific de-identified data that preserves confidentiality to the extent allowed by NIMH will be shared.