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, parent, and provider 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.
The investigators will conduct this study at three pediatric clinics. The principal
investigator will enroll 30 providers from three participating pediatric clinics. Those
providers who are interested will complete a consent form and a short demographic
questionnaire. Eligible patients of participating providers will be called by clinic
staff who will explain the study. The clinic staff will ask interested families to arrive
20 minutes before their next visit to meet with a research assistant to learn more about
the study. The investigators will enroll 140 youth (approximately 40 to 60 from each
clinic). 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. Parents will be asked to complete HIPAA forms. Then the research assistant will
administer the eligibility screener. Youth will be randomized to either the question
prompt list only group (N=35), the pre-visit video only group (N=35), the combined
question prompt list/video intervention group (N=35), or the control group (N=35),
stratified by provider. This will ensure group balance. 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, the research assistant will collect the
youth's and parent's question prompt lists so that the investigators can compare what
questions the youth and parent wanted to ask to what the youth and parent asked during
the visit.
Youth typically come back for ADHD follow-up visits every 3 months. Families in the
intervention groups will receive the intervention to which the families 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 audiotape the 3 month visit since the investigators 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 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.
Youth will receive a small stipend for each interview and parents will receive a small
stipend as well for completing the questionnaire at each time point (baseline, 3 months,
and 6 months). The investigators will ask teachers to complete the Vanderbilt symptoms
and performance assessments at baseline, 3 months, and 6 months. Teachers will receive a
small stipend at each data collection point.
Towards the end of the trial, the investigators will hold a lunchtime meeting with the
providers at each clinic and ask the teachers to complete validated and reliable measures
of intervention acceptability, feasibility, and tolerability for each intervention group
(question prompt lists, video, question prompt lists and video). The providers will each
receive a small stipend for their time. The adolescents in the intervention groups will
complete the acceptability, feasibility, and tolerability questions at the 6-month
interviews and the parents will complete them in the 6-month questionnaires.