Improving the Outcomes of Adolescents With ADHD Via a Pre-visit Question Prompt List/Video Intervention: a Randomized Controlled Feasibility Trial
Phase: NA
Conditions: ADHD
Sponsor: University of North Carolina, Chapel Hill

 
 
 
Improving the outcomes of adolescents with ADHD via a pre-
visit question prompt list/video intervention: a randomized 
controlled feasibility trial 
 
 
NCT number: NCT05835362 
 
Document Date: 2/12/2026 
 
 

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Complete Title: Improving the outcomes of adolescents with ADHD via a pre-visit question prompt list/video 
intervention: a randomized controlled feasibility trial 
 
 
 
Short Title: Pre-visit intervention to improve adolescent outcomes with ADHD 
Sponsor: National Institutes of Health 
Protocol Date: 2/12/2026 
 
 
 
 
 
 
Sponsor: 
National Institutes of Health (NIH) 
Bethesda, MD 20892 USA 
 
Study Principal Investigator: 
Betsy Sleath, PhD 
UNC Eshelman School of Pharmacy 
Division of Pharmaceutical Outcomes and Policy 
Kerr Hall Room 2213  CB # 7573 
Chapel Hill NC 27599-7573 
919-962-0079 (CH office); 919-966-8486 (fax) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL TITLE: Improving the outcomes of adolescents with ADHD via a pre-visit question prompt list/video 
intervention: a randomized controlled feasibility trial 
 
Short Title:  
Pre-visit intervention to improve adolescent outcomes with ADHD 
 
Lead Investigator: 
Betsy Sleath, PhD 
University of North Carolina at Chapel Hill 
Version Date: February 12, 2026 
 
I confirm that I have read this protocol and understand it.    
 
Principal Investigator Name:   
 
  Betsy Sleath______________ 
 
Principal Investigator Signature:  
 
 
 
 
 
 
 
Date:   
 
 
 
 
February 12, 2026________________ 
 
 
 
 

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TABLE OF CONTENTS 
 
ABBREVIATIONS AND DEFINITIONS OF TERMS ....................................................................................................................... 5 
PROTOCOL SYNOPSIS .............................................................................................................................................................. 6 
BACKGROUND AND RATIONALE ............................................................................................................................................. 9 
1. STUDY OBJECTIVES.......................................................................................................................................................... 10 
2. INVESTIGATIONAL PLAN (BRIEF OVERVIEW) .................................................................................................................. 10 
2.1 
STUDY DESIGN ......................................................................................................................................................... 10 
2.1 
STUDY DURATION, ENROLLMENT AND NUMBER OF SUBJECTS ......................................................................................... 10 
2.2 
STUDY POPULATION ................................................................................................................................................. 11 
3 
STUDY PROCEDURES ....................................................................................................................................................... 11 
4 
STUDY EVALUATIONS AND MEASUREMENTS ................................................................................................................. 12 
5 
STATISTICAL CONSIDERATIONS ...................................................................................................................................... 12 
6 
STUDY INTERVENTION .................................................................................................................................................... 14 
7 
SAFETY MANAGEMENT ................................................................................................................................................... 14 
8 
DATA COLLECTION AND MANAGEMENT ........................................................................................................................ 15 
9 
CONSENT PROCESS ......................................................................................................................................................... 15 
10 REFERENCES .................................................................................................................................................................... 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
Abbreviation 
Definition 
ADHD 
Attention-Deficit/Hyperactivity Disorder 
HIPAA 
Health Insurance Portability and Accountability Act 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SYNOPSIS 
  
Study Title 
Improving the outcomes of adolescents with ADHD via a pre-visit 
question prompt list/video intervention: a randomized controlled 
feasibility trial 
Funder 
National Institutes of Health 
Clinical Phase 
Phase 3 
Study Rationale 
 
• 
Adolescents and their caregivers asked few questions during 
ADHD visits despite indicating that they have many.  
• 
A pre-visit question prompt list/video intervention can improve 
communication and clinical outcomes for adolescents with 
different chronic conditions. 
• 
No one has examined whether a pre-visit video only, question 
prompt list alone, or both improve adolescent and caregiver 
question-asking and the outcomes of adolescents with ADHD the 
most compared to usual care. 
Study Objective(s) 
 
• 
To examine whether the ADHD question prompt lists and/or pre-
visit video significantly impact the proposed mechanisms of the 
intervention. We 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. 
• 
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.  
• 
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. 
 
Test Article(s) 
 
Question prompt list only, video only, question prompt list and video, or 
usual care 
Study Design 
 
This is a randomized controlled feasibility trial design where adolescents 
with ADHD are assigned to one of four groups: ADHD question prompt 
list only, pre-visit ADHD video only, pre-visit ADHD video and question 
prompt list, usual care 

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Subject Population 
key criteria for Inclusion 
and Exclusion: 
Data will be collected at pediatric clinics in North Carolina.  
Inclusion Criteria 
1. Ages 11 to 17 
2. Speak and read English 
3. Have an ADHD diagnosis 
4. Are present at the clinic for an ADHD visit 
5. Screen as having predominantly inattentive subtype, 
hyperactive/impulsive subtype, or combined inattention/hyperactivity on 
the Vanderbilt parent assessment scale 
Exclusion Criteria 
1. There are no exclusion criteria. 
 
Number Of Subjects  
 
Up to 140 
Study Duration 
Each subject’s participation will last 6 months. 
The entire study is expected to last 2 years and 6 months. 
Study Phases 
Screening 
Study Treatment 
Follow-Up   
Screening: Interested families will be referred to a research assistant 
based at the clinic to learn more about the study. If the family is 
interested, the research assistant will obtain parent informed consent, 
parent permission, and youth assent. Parents will be asked to complete 
HIPAA forms. Then the research assistant will administer the eligibility 
screener. 
Intervention: Youth will be randomized to either the question prompt list 
only group, the pre-visit video only group, the combined question prompt 
list/video intervention group, or the control group, stratified by provider. 
Using a random number generator, the biostatistician will prepar opaque, 
sealed envelopes containing group assignments. The research assistant 
will open the envelope when a youth enrolls into the study. 
Follow-up: The research assistant will interview all youth and have the 
parent complete a questionnaire after the 3 and 6 month visits. The 
youth’s medical records will be reviewed for the 6-month period before 
enrollment into the study and the 6-month period after.  
 
Efficacy Evaluations 
Primary Outcomes: 
Vanderbilt Assessment Total Symptom Score (parent informant): The 
Vanderbilt parent informant ADHD rating scales are DSM-IV-based scales. 
The parent Total Symptom Scores (TSS) will be calculated by summing a 
Total Symptom Score the scores on each item; summary scores can 
range from 0 to 54. Higher scores indicate worse symptoms. We will 
examine changes over time, using the summary score. 
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 

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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. We will 
examine changes in the score over time. 
Secondary Outcome: 
Pediatric Quality of Life Inventory (PedsQL):  The 23-item PedsQL has 
strong reliability and validity when used with youth with ADHD. It 
measures four dimensions of the child’s quality-of-life: (a) physical 
functioning, (b) emotional functioning, (c) social functioning, and (d) 
school functioning. The items are reverse scored and are transformed to 
a 0 to 100 scale with higher scores indicating better quality-of-life. 
Statistical And Analytic 
Plan 
We will use ANCOVA to investigate which intervention arm (ADHD 
question prompt lists, pre-visit video, or pre-visit video and ADHD question 
prompt lists) results in the greatest change (compared to the usual care 
group) in ADHD symptoms, school and social performance, and quality-of-
life at 6 months.  
Data And Safety 
Monitoring Plan 
The project manager will travel to the clinics at least once every two 
months to review data quality. The study has a Data Safety and 
Monitoring Board who will review study data twice a year. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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BACKGROUND AND RATIONALE 
 
 
Attention-deficit/hyperactivity (ADHD) disorder is one of the most prevalent mental health conditions among youth and 
the majority of youth with ADHD are cared for in primary care settings.1-5 Prior work indicates that youth with ADHD have 
poorer quality-of-life and functioning than youth without ADHD.6-15 Because better youth-parent-provider communication 
has been linked with better youth outcomes longitudinally, increasing family involvement during ADHD primary care visits 
could improve the quality-of-life and functioning of youth.16, 17   
Few studies have examined youth and parent engagement during ADHD visits.18-20 Specifically, Brinkman et al.21 found low 
levels of shared decision-making during pediatric ADHD visits. In our own study of 67 youth with ADHD (ages 8-17) from 
five pediatric clinics, we found that less than 5% of parents and 2% of youth asked their providers questions about ADHD.22 
In a separate study of 70 youth with ADHD, we found that youth had an average of 8 questions about ADHD and parents 
an average of 8.9 questions that they wanted to ask providers.23 Thus, even though youth and parents have questions 
about ADHD, they are not asking those questions during office visits. We also found that the primary place where youth 
want to learn about ADHD is the provider’s office.23 
Simple interventions, such as novel pre-visit videos and prompt lists, which are easy to implement and disseminate, are 
needed to engage youth and parents more during ADHD pediatric primary care visits. We were one of the first research 
teams to use question prompt lists with youth.24 In our prior work, we found that a youth asthma video and question 
prompt list intervention significantly increased youth question-asking and provider education about asthma.24, 25  We also 
found that youth who received the intervention and asked their providers questions were significantly more likely to have 
improved quality-of-life and asthma control at 12 months.26   
Using Social Cognitive Theory as a guide, we 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, we also hypothesize that youth ADHD symptoms, school and social performance, and quality-of-life will improve. 
In focus groups with a total of 14 providers, 12 adolescents, and 13 parents, 100% of participants were strongly supportive 
of an ADHD question prompt list/video intervention to motivate families to ask more questions during primary care visits. 
The focus groups provided valuable feedback on the adolescent and parent ADHD question prompt lists and on the key 
topics the pre-visit video should cover to encourage question-asking: (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. The novel video was then produced in partnership with adolescents. There is a need 
to conduct a pilot randomized controlled feasibility trial to evaluate the feasibility and effectiveness of the intervention. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. STUDY OBJECTIVES 
 
The overall objective of this pilot randomized controlled feasibility trial is 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.  We have three specific aims: 
 
1.1 Aim 1: To examine whether the ADHD question prompt lists and/or pre-visit video significantly impact the proposed 
mechanisms of the intervention. We 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. 
 
1.2  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.  
 
1.3 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. 
 
2. INVESTIGATIONAL PLAN (brief overview) 
 
2.1 Study Design 
The study is a pilot randomized controlled feasibility trial of the video/prompt list intervention that will inform the 
design of a future larger trial.   
Screening: Interested families will be referred to a research assistant based at the clinic to learn more about the study. If 
the family is interested, the research assistant will obtain parent informed consent, parent permission, and youth 
assent. Parents will be asked to complete HIPAA forms. Then the research assistant will administer the eligibility 
screener. 
Intervention: Youth will be randomized to either the question prompt list only group, the pre-visit video only group, the 
combined question prompt list/video intervention group, or the control group, stratified by provider. Using a random 
number generator, the biostatistician prepared opaque, sealed envelopes containing group assignments. The research 
assistant will open the envelope when a youth enrolls into the study. 
Follow-up: The research assistant will interview all youth and have the parent complete a questionnaire after the 3 and 6 
month visits. The youth’s medical records will be reviewed for the 6-month period before enrollment into the study and 
the 6-month period after.  
 
2.2 Study Duration, Enrollment and Number of Subjects 
The study includes up to 140 adolescents.  The study duration is 6 months for each participant.  The overall study 
duration will be 2 years and 6 months. 
 

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2.3 Study Population 
Participants will be enrolled from North Carolina pediatric practices. 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.  
 
3. STUDY PROCEDURES  
 
The study team will recruit pediatric clinics to participate.  They will then obtain informed consent from health care 
providers who want to participate. Clinic staff will refer families interested in learning about the study to a research 
assistant to learn more about the study. We will enroll up to 140 youth. The UNC research staff will explain the study. 
The research assistant will take the family to a private area within the clinic to learn more about the study. The research 
assistant will obtain parent informed consent, parent permission, and youth assent will be obtained. Parents will be 
asked to complete HIPAA forms. Then the research assistant will administer the eligibility screener. We will record why 
families refuse to participate and why they were ineligible.  
 
Youth will be randomized to either the question prompt list only group, the pre-visit video only group, the combined 
question prompt list/video intervention group, or the control group, stratified by provider. This will ensure group 
balance. We are including a usual care control group because we need to control for the many factors that might 
influence communication (such as youth age, parent educational level, etc.). By randomizing families to the four groups, 
these factors should be evenly distributed across the groups.  
 
Using a random number generator, the biostatistician will prepare opaque, sealed envelopes containing group 
assignments. The research assistant will open the envelope when a youth enrolls into the study. Youth and parents in 
question prompt list group will be handed the prompt lists 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.” Parents and youth in the pre-visit video only group will watch a short 
educational video with six themes on an iPad encouraging families to ask questions and to be engaged during ADHD 
visits. Youth and parents in the combined pre-visit video/question prompt list group will watch the video and will then 
be handed the question prompt lists and given the instructions above. The control group will receive usual care. 
 
Next, all participating families (both the intervention and control group families) will have their medical visits audio-tape 
recorded. After the medical visit, the research assistant will conduct a 15- to 20-minute interview with all participating 
youth while parents complete a questionnaire. For those in the question prompt list or combined video/question 
prompt list intervention groups, we will collect the youth’s and parent’s question prompt lists so that we can compare 
what questions the youth and parent wanted to ask to what they asked during the visit. 
 
If the team has any concerns about youth harm to self or others, they will refer the family to the primary care provider 
and Rob Christian, MD (co-investigator) for assistance. The team will report concerns to the state to the extent required 
by North Carolina law. If the patient states any concerns about adverse events from ADHD medications, the team will 
advise the family to alert the primary care provider immediately. Of note, no adverse events occurred in the pilot study 
with 20 families. 
 
Youth typically come back for ADHD follow-up visits every 3 months. Families in the intervention groups will receive the 
intervention to which they were randomly assigned to use at each follow-up visit. The research assistant will interview 
all youth and have the parent complete a questionnaire after the 3 and 6 month visits. The research assistant will audio-
tape the 3 month visit since we will be examining how baseline and 3 month communication is associated with 6 month 
outcomes. The youth’s medical records will be reviewed for ADHD diagnosis date, co-morbidities, number of ADHD 

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visits, and ADHD treatment use (medications and other strategies) for the 6-month period before enrollment into the 
study and the 6-month period after.  
 
4. STUDY EVALUATIONS AND MEASUREMENTS   
 
4.1 Primary Outcomes 
Vanderbilt Assessment Total Symptom Score (parent informant): The Vanderbilt parent informant  ADHD rating scales 
is a DSM-IV-based scale, which gives a Total Symptom Score.10-12 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.10, 14, 27 The Vanderbilt has demonstrated acceptable internal 
consistency, adequate factor structure, and good reliability and validity as a measure of youth behavior and school 
functioning.10 The Vanderbilt includes 18 DSM-IV symptoms that are rated on a 4-point Likert scale ranging from 0 to 3. 
Both the parent 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. We will examine changes over time, using the summary 
score. 
 
Youth functioning using the Vanderbilt Assessment (parent informant) Average Performance Score:10-12 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. We will examine changes in the score over time. 
 
4.2 Secondary Outcome 
Pediatric Quality of Life Inventory (PedsQL):  The 23-item PedsQL has strong reliability and validity when used with 
youth with ADHD. 13-15, 28, 29 It measures four dimensions of the child’s quality-of-life: (a) physical functioning, (b) 
emotional functioning, (c) social functioning, and (d) school functioning. The items are reverse scored and are 
transformed to a 0 to 100 scale with higher scores indicating better quality-of-life. 
 
5. STATISTICAL CONSIDERATIONS  
 
5.1 
Statistical Methods 
 
Baseline comparisons 
Characteristics of youth, their parents, and their providers will be presented by treatment group and clinic. Unadjusted 
statistical comparisons, using ANCOVA and the chi-square test or Fischer’s exact test will be made between the 
treatment groups and usual care.  
 
Analysis by Aim 
Aim 1: To examine whether the ADHD question prompt lists and/or pre-visit video significantly impacts the proposed 
mechanisms of the intervention, we will use ANCOVA to investigate which intervention arm (ADHD question prompt lists, 
pre-visit video, or pre-visit video and ADHD question prompt lists) results in the greatest change (compared to the usual 
care group) in adolescents and parents: (a) asking more questions and receiving more provider education about ADHD 
during their baseline and 3 month visits and (b) having higher self-efficacy at 3 and 6 months.   
 
We will examine how trial arms impact family question-asking and provider education directly after the baseline visit. 
We will examine how trial arms impact family question-asking, provider education and parent and adolescent self-
efficacy at 3 months. Additionally, we will examine how trial arms impact the number of questions families ask at 

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baseline and 3 months combined and the number of areas providers educate about at baseline and 3 months combined. 
Our models will account for clustering by provider, and in addition to main effects of the intervention, will include 
several covariates including demographic characteristics such as adolescent race, ethnicity, length of time with ADHD, 
and parental education attainment. To help us determine whether we should use the combined pre-visit video and 
question prompt list or just the pre-video or just the question prompt list in the larger trial, we will perform multiple 
comparisons and use Hochberg’s30 false discovery rate to control overall study-wide type I error at α=0.05. 
 
We expect less than 10% attrition over the 6 months based on our recent pilot with 20 families. We will explore reasons 
for and mechanisms of missing data to support Aim 1 and 2 analyses. We will use descriptive statistics to summarize the 
rates and patterns of missing data. We will compare proportions of missing outcome measures (mechanisms of action and 
our primary and secondary outcomes), at 3- and 6-month follow-ups by the four treatment groups using chi-square tests 
(or Fisher’s exact tests as appropriate). We will test for differences in mean values and proportions of baseline measures 
between participants with and without missing outcome measures at 3- and 6-month follow-up using t-tests and chi-
square tests. We will summarize patterns of missingness of the follow-up measures to assess if they monotone or arbitrary. 
To test whether outcome measures are missing completely at random (MCAR) we will use Little’s χ2 test.31 In sensitivity 
analyses, we will use multiple imputations (MI).32 This approach accounts for the uncertainty that arises when imputing 
missing values and requires the less restrictive missing at random (MAR) assumption. Our imputation model will include 
all variables included in the analyses of mechanisms of action, primary outcomes as well secondary outcomes. 
 
Aim 2: To investigate the effectiveness of the ADHD question prompt lists and/or 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. As in Aim 1, we will use ANCOVA to investigate 
which intervention arm (ADHD question prompt lists, pre-visit video, or pre-visit video and ADHD question prompt lists) 
results in the greatest change (compared to the usual care group) in ADHD symptoms, school and social performance, and 
quality-of-life at 6 months. As in Aim 1, we will apply the same analytic approaches to handle missing data and conduct all 
of the analyses to explore the heterogeneity of treatment effects. If the interventions have significant effect on our 
outcomes, we will also examine how the mechanisms examined in Aim 1 (question-asking, provider education, adolescent, 
and parent self-efficacy) impact ADHD symptoms, performance, and quality-of-life at 6 months. This will help us determine 
which mechanisms have the greatest impact on outcomes as we plan for the future trial. 
 
To examine the dose of the intervention and its effect on our outcomes, we will first conduct descriptive analyses and 
assess whether levels of intervention exposure vary by youth and parent characteristics. For each of our intervention arms, 
we will use Kendall’s coefficient of rank correlation to evaluate the extent of the association between the number of times 
a family receives the intervention and each our primary and secondary outcomes. We will examine the distributions of 
the intervention dose and, if appropriate, we will categorize them into groups to allow for nonlinear relationship in the 
multivariate models. As in Aim 1, we will use ANCOVA to evaluate whether the number of times family receives the 
intervention significantly affects our primary and secondary outcomes. First, we will run separate models for each the 
three intervention groups to assess how intervention dose affects outcomes by study arm. Second, we will run a model 
on the entire sample and include the three types of intervention doses as independent variables. Control arm participants 
will have values of zero coded for the three intervention dose variables.   
 
Aim 3: Assess adolescent and parent feedback on the acceptability, feasibility, tolerability, and safety of using the ADHD 
question prompt lists and/or pre-visit video. 
We will examine the quantitative data from adolescents and parents about the acceptability, feasibility, and tolerability 
of intervention arms as well as the qualitative data as to why adolescents, parents, and providers choose their answers to 
determine which intervention to use in the larger trial (ADHD question prompt lists only, pre-visit video only, pre-visit 
video and ADHD question prompt lists). We will examine means and standard deviations to see if any intervention scored 
particularly low on acceptability, feasibility, and tolerability. We will examine safety results (adverse events, drop-outs) 
and any negative feedback about any of the intervention arms from adolescents, parents, and providers to help us 
determine which intervention to use in the larger trial (ADHD question prompt lists only, pre-visit video only, or pre-visit 
video and ADHD question prompt lists).   

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5.2 
Sample Size and Power 
 
We present sample size justifications for our primary outcomes, based on the assumption that the results from this 
research will inform the design of our future main trial. We follow a confidence interval approach outlined by Cocks et 
al. 2013 and hypothesize that at least one of our active intervention groups will lead to an improvement in health 
outcomes.33 This method identifies sample size requirements for a pilot trial such that if the observed difference 
between the groups (in the pilot trial) is zero, then the upper limit of the confidence interval will exclude the estimate 
that is considered clinically meaningful in the planned main trial. In our earlier study of youth with asthma25 as well as in 
our small pilot trial of 20 adolescents with ADHD, we found that the question prompt list combined with the video 
intervention significantly increased youth question-asking. Both studies strongly indicated medium to large effect sizes 
(range of Cohen’s h for difference in proportions: 0.42 – 0.98) for this mechanism of action; therefore, we provide our 
sample size justification for our main outcomes for which smaller effect sizes still reflect clinically meaningful 
differences. The providers on our team suggested that a difference of 5 points in the Vanderbilt ADHD Total Symptoms 
score (parent) and a change of 3 points in the Vanderbilt Youth Performance score (parent) reflect a clinically meaningful 
reduction in the severity or number of symptoms. For example, we expect the average ADHD symptom score in the 
control group to be 28 and expect a decrease to 23 or lower for participants in one of our intervention groups. 
Therefore, we present our justification assuming a small-medium effect size (Cohen’s d for difference in means = 0.35),  
34 which reflects a 5-point change in ADHD symptoms with a standard deviation of 14. Change of 3 points in the parent 
Vanderbilt performance score with a standard deviation of 6 translates to a larger standardized effect size of d=0.5. Our 
estimates of standard deviations come from the published literature.6-12, 14, 22, 23, 35 Further, to account for the fact that 
we will be performing multiple comparisons with the control group, we assume a one-sided 90% confidence interval (CI) 
for our justification, which is more conservative than 80% suggested by the original publication. A one-sided CI is chosen 
because we will only be interested in proceeding with the larger trial if there is some evidence of effectiveness in this 
pilot trial. Even though data from our ADHD pilot study with 20 families suggest a maximum attrition of 10%, we 
conservatively assume an attrition rate of 15%. Based on all of these assumptions, we anticipate enrolling 140 patients 
or 35 per study arm. This sample of 140 would be sufficient to produce an upper limit of a one-sided 90% CI which would 
exclude 0.35, assuming the null hypothesis of no difference between control and intervention arms is true for this 
proposed study (i.e., calculated upper 90% CI =0.3488). Additionally, our estimate of 35 participants per group is in 
agreement with and more conservative than sample sizes recommended for pilot trials published in the literature.36, 37 It 
also aligns with the published recommendations regarding sample size requirements necessary to estimate design 
parameters for our main trial.38  
6. STUDY INTERVENTION 
 
Families are assigned to one of three pre-visit intervention groups or usual care. The three intervention groups are: 
Question Prompt List Only: Youth and their caregivers receive ADHD question prompt lists before their visits to 
complete for use during visits. 
Video Only: Youth and caregivers watch a short video on the importance of asking questions about ADHD and its 
treatment during pediatric visits. 
Question Prompt List and Video: Youth and caregivers watch a short video on the importance of asking questions about 
ADHD and its treatment during pediatric visits and youth and parents complete ADHD question prompt lists for use 
during visits. 
 
7. SAFETY MANAGEMENT  
 
All data that will be used is de-identified. The data will be stored on password protected computers.  Informed consent 
and assent will be obtained from all youth, parents, and providers who participate in the study.  All data will be stored in 
a secured fashion.  Additionally, we will obtain parent permission for youth participation. Parents will also sign HIPAA 
forms.  Code numbers will be assigned to youth, parents, and providers and any information that could identify youth, 
parents, or providers participating in this project will not be included in any data sets.  Also, the audio-tapes of visits will 

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be transcribed into text and then erased.  All identifiers will be removed and replaced by blank lines. All data will be 
reported in aggregate and no individual will be identified. 
 
If any member of the research team has any concerns about adolescent harm to self or others, they will refer the family 
to the primary care provider and Rob Christian, MD (co-investigator) for assistance. 
 
8. DATA COLLECTION AND MANAGEMENT  
 
8.1 Data collection and confidentiality of the data 
The project manager will travel and visit the clinics at least once every 2 months to review data quality.  Code numbers 
will be assigned to youth, parents, and providers and any information that could identify youth, parents, or providers 
participating in this project will not be included in any data sets. The audio-tapes will be kept on a secure HIPPA 
compliant server. Also, the audio-tapes of visits will be transcribed into text and then erased.  All identifiers will be 
removed and replaced by blank lines in the transcripts. All data will be reported in aggregate and no individual will be 
identified.  Data will be stored in a locked filing cabinet in a locked office separate from the consent forms. All data will 
be entered by the project manager under unique identifiers.  The statistician will perform all analyses using de-identified 
datasets. 
 
8.2 Monitoring Plan 
As Principal Investigator, Dr. Sleath will have overall responsibility for the study. She will report any problems to the UNC 
Institutional Review Board.  The Institutional Review Board will provide ongoing monitoring for this investigation. This 
study has minimal risk because the intervention is focused on improving communication during medical visits and 
subsequent health outcomes.  However, an independent and unbiased review of the study’s ongoing progress will be 
provided by the Data and Safety Monitoring Board. The Data and Safety Monitoring Board will meet twice a year to 
monitor the study.  Its primary responsibility will be to review the progress of the study to minimize risk and to decide 
whether or not the study should continue.  To help them with their assessment, Drs. Sleath, Carpenter, and Annis will 
furnish the board with the appropriate monitoring data before each meeting. 
 
9. CONSENT PROCESS 
 
 
All study procedures will be explained fully to interested families by a member of our UNC research team staff who will 
be based at the clinics. The research staff member will be able to answer any questions the patient has about the study. 
All parents will be asked to review and sign an informed consent, parent permission, and HIPAA form. The 
consent/assent process will occur in a private area in the clinic. Youth will be asked to review and sign an assent form.  
Some participants may feel uncomfortable having their physician visits audio-tape recorded when discussing sensitive 
issues. The research staff member will let them know they can ask the provider to turn off the audio recorder at any 
time during the medical visit Also, the research staff member will tell participants they do not have to answer any 
questions in the survey that make them feel uncomfortable. After reviewing each section of the consent with the 
participating families the research staff will ask both parent/child if they have any questions or concerns regarding their 
participation. Enough time will be given to answer questions to make sure family understands what it takes to 
participate in the project. The signed assent, consent, parent permission, and HIPAA forms will be kept in a locked file 
cabinet, and copies will be given to the patients. 
 
 
 
 
 
 

Page 16 of 18 
 
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