Improving the Outcomes of Adolescents With ADHD Via a Pre-visit Question Prompt List/Video Intervention: a Randomized Controlled Feasibility Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- Youth functioning using the Vanderbilt Assessment (parent informant) Average Performance Score
Study Overview
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.
Detailed Description
Using Social Cognitive Theory as a guide, the investigators hypothesize that an ADHD video/question prompt list intervention will increase youth and parent question-asking which, in turn, will increase provider education during the medical visit, which ultimately will improve youth and parent ADHD self-efficacy. Youth and parent question asking, provider education, and self-efficacy are the proposed mechanisms of the intervention. By improving youth and parent self-efficacy to manage ADHD, the investigators also hypothesize that youth ADHD symptoms, school and social performance, and quality-of-life will improve.
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 ADHD. The team 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 us 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 11 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Child does not have ADHD.
- •Child is not between the ages of 11 and
- •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.
Arms & Interventions
Control group
The control group will receive usual care.
Outcomes
Primary Outcomes
Youth functioning using the Vanderbilt Assessment (parent informant) Average Performance Score
Time Frame: 6 months
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.
Vanderbilt Assessment Total Symptom Score (parent informant)
Time Frame: 6 months
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.
Change in Vanderbilt Assessment Total Symptom Score (as Reported by Parent About Youth)
Time Frame: Baseline, 6 months
Vanderbilt Assessment Total Symptom Score (as reported by parent about youth) 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 includes 18 DSM-IV symptoms that are rated on a 4-point Likert scale ranging from 0 to 3. The 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.
Change in Youth Functioning Using the Vanderbilt Assessment Average Performance Score (as Reported by Parent About Youth)
Time Frame: Baseline, 6 months
The Vanderbilt average performance score (as reported by parent about youth) 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 with a total range of 1-5. Higher scores indicate worse performance.
Secondary Outcomes
- Change in Pediatric Quality of Life Inventory (PedsQL)(Baseline, 6 months)
- Pediatric Quality of Life Inventory (PedsQL)(6 months)