Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04473755 |
| Other study ID # |
800012103 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 4, 2020 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
Florida International University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The objective of this study is to assess the burden and impact of ADHD impairment in the
early morning and late afternoon/evening hours for adolescents and young adults. Functional
impairments will focus on the currently identified areas of functional impairment in the
Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric
Association, 2013) - namely, social, academic, and occupational functioning. This is
necessary for two reasons: (1) the current literature on ADHD impairment and functioning is
concentrated within elementary school children; and (2) studies of intervention effectiveness
are typically concentrated during the school day. This current state of the literature
ignores the obvious - as ADHD is a chronic disorder, it needs to be addressed as children
grow into adolescence and young adulthood, and it needs to be remediated at times outside of
the school day such as in the morning and late afternoon/evening.
Therefore, the specific areas assessed in the present study will relate to driving, school,
work, and family functioning. These are important areas to study, as the research literature
has typically focused on elementary school and school-day behavior in assessments of symptom
presentation, impairment, and treatment outcome. As individuals with ADHD grow older, the
entire day becomes relevant in determinations of functioning (e.g., workdays may begin in the
very early morning or last into the evening/night), and productivity can be assessed across
waking hours rather than just across the elementary school day. Once areas of functional
impairment in these times of day are determined, for this age group, treatment candidates can
aim to address these treatment targets.
Description:
Study aims are as follows:
1. To investigate the impairment present in the morning and late afternoon/evening for
individuals with ADHD, relative to a non-ADHD group.
a. Hypothesis: Individuals with ADHD will illustrate more impaired functioning in the
morning and late afternoon/evening, relative to a non-ADHD group in the following
domains: i. Risky Driving ii. School/Workplace related behavior (e.g., time on-task in
the evening, management of weekly schedule) iii. Family and social functioning
2. Develop a set of recommendations for the evidence-based assessment of morning and late
afternoon/evening behavior of individuals with ADHD.
1. Hypothesis: It is hypothesized that a multi-method, multi-domain assessment of
impaired functioning will yield the most clinically defensible assessment approach.
Rolling enrollment will be used in this study. Participants will attend an intake visit to
provide informed consent for participation in the study, and collect baseline and diagnostic
information. The targeted population will be youth and young adults between the ages of 16-30
with a valid driver permit or license. To determine eligibility for the study, participants
will complete (1) a self-report of ADHD symptoms (Molina, Smith, & Pelham, 2001; Pelham,
Gnagy, Greenslade, & Milich, 1992), (2) the Impairment Rating Scale (Fabiano et al., 2006;
Sibley et al., 2012a); and (3) a semi-structured Disruptive Behavior Disorders interview with
a clinician to obtain contextual information on symptoms and impairment over the last six
months (Hartung et al, 2005). Participants will also complete the WASI-2 to ascertain an
estimate of IQ. Additionally, a collateral rater (i.e., parent or significant other; Sibley
et al., 2012a, 2012b) will report on the participant's ADHD symptom ratings for the past six
months and retrospectively provide a report on childhood symptoms. The collateral rater will
also complete an Impairment Rating Scale based on the last six months. Participants will be
classified as ADHD if there are at least 4 symptoms of inattentive and/or
hyperactive-impulsive behaviors endorsed at clinically significant levels, evidence of onset
of ADHD prior to age 12, and current psychosocial impairment (Sibley et al., 2012a, 2012b).
To reduce variability between the ADHD and non-ADHD groups, we will match participants on age
(+/- 2 years), sex, and whether they are employed or unemployed.
Eligible participants in either the ADHD or non-ADHD group will then have a meeting with the
research team to initiate data collection methods over a two-week time period (i.e., 14 early
morning and 14 late afternoon/evening assessments; N=28 assessments/participant total). This
amount of repeated measurement should be adequate for detecting differences in participants
(e.g., Ferguson et al., 2012). To accurately capture the diverse array of potential
functional impairments in the early morning and late afternoon/evening hours, a multi-method
approach to data collection will be utilized. The keystone of the data collection process
will be via the adolescent/young adult's smart phone. In our data collection approach we will
use commercially available and commonly employed (e.g., smartphones) measurement tools to
develop a method of data collection that may be eventually appropriate for scale in the
adolescent/young adult population. Using an application that permits geo-location,
information on driving, and timestamps for location (e.g., Life360.com), the participants'
self-management within key functional domains will be assessed. The following data will be
collected:
Morning and Evening Routine. Participants will provide a weekly schedule for the upcoming
week. Using this information, mobile technology will be used to determine success with
meeting expectations for morning routine (e.g., waking up; leaving for school/work; falling
asleep). Mobile technology will track sleeping habit and time of wakening, and geo-fencing
will set an alert when the participant leaves the home. Using an idiographic list of
responsibilities for work/school/home, we will monitor performance toward goal attainment as
we have done in related studies in the natural and laboratory setting (Fabiano et al., 2010;
Fabiano et al., 2018).
Driving. Early morning and late afternoon/evening driving will be monitored using the
participants' smartphone application, which includes the Driver Protect feature. Driver
Protect includes driving reports that include potentially unsafe behaviors (phone use to text
while driving, speeding, hard braking, collisions) as well as 30 days of location history. We
will collect companion driving performance information using the Life360 app which will log
all trips conducted by the driver, total miles traveled, record top speed for each trip, and
record frequency counts of hard/extreme braking and acceleration. Similar tools have been
successfully used in prior studies (Fabiano et al., 2011; Fabiano et al., 2016) and they are
well-tolerated by participants.
Family and Social Functioning. Ecological, momentary assessment will be used to assess family
and social functioning based on report from both the participant and identified
collateral(s). Ecological, momentary assessment is an approach that uses a smartphone based
prompt (i.e., in a text message) to ask the participant about behavior/functioning/mood at
that moment (e.g., Miguelez-Fernandez, et al., 2018). Participants and collaterals will be
contacted in the early morning and late afternoon/evening hours to obtain information on
typical activities, individuals they are interacting with, and to obtain a brief rating of
functional impairment using the Impairment Rating Scale (Fabiano et al., 2006). Participants
and collaterals will be contacted at least once each morning and once each afternoon/evening
daily, for two weeks.
ADHD Symptoms and Impairment. As part of the assessment of family and social functioning
probes, we will also administer a brief probe of ADHD symptoms and impairment. We will
include the six symptoms from the Adult ADHD Self-Report Scale (Kessler, et al., 2007) and
the overall impairment item on the Impairment Rating Scale (Fabiano et al., 2006). Data for
this measure will be collected during both the early morning and late afternoon/evening
assessment periods.
Our prior work illustrated little reactivity with observations of behavior, even in
high-profile situations such as driving. Indeed, when teenagers with ADHD (16-18) had their
cars outfitted with on-board cameras facing the cabin and the roadway, there was no
difference in rates of risky driving during the first and last weeks (Fabiano et al., 2016),
and collaterals (parents) and teens illustrated coercive interactions strategies during these
on-board assessments (Schatz, Fabiano et al., 2014). In addition, parenting and teen
behaviors in the laboratory regarding a conflictual topic yielded sufficient behavioral
variability across positive and negative parent/teen behaviors (Fabiano et al., 2016); it is
expected that in-home, ecological, momentary assessment will be even more effective at
generating information on social functioning. These results suggest that there will be
acceptable rates of behavioral variability during the two-week assessment period and this is
also an assessment period of reasonable length to prevent attrition.
