Abstract
Purpose
Research involving adolescent risk behaviors must balance data confidentiality with
participant safety when risky behaviors are revealed. This report details a safety
protocol and reports the experience of two contemporaneous studies that used it with
variant safety thresholds.
Methods
We developed a safety protocol for research with adolescent patients and used it in
two concurrent studies of adolescent patients, aged 14–18 years. Study “PC” recruited
participants from a primary care adolescent medical clinic (N = 490), and Study “SP”
recruited participants from subspecialty pediatric clinics (N = 434); both studies
involved a similar self-administered assessment of health behaviors. The protocol
sets thresholds for clinical intervention (positive safety flags) for past 3-month
heavy alcohol consumption (Study PC: 10 or more drinks and Study SP: “binge-”level
drinking), illicit drug use other than marijuana and alcohol in combination with a
substance other than marijuana, and sets a positive screen for depression. We examined
the rates of positive safety flags in both protocol settings, used significance testing
to describe demographic differences between participants with and without positive
flags in both studies, and described clinician experiences with protocol implementation.
Results
In studies PC/SP, .6%/8.8% of participants were flagged for heavy alcohol consumption,
respectively; .2%/0% for illicit drug use, 2.2%/.7% for combination substance use,
and 14.9%/4.8% for depression. Some clinicians found managing positive flags challenging,
although both studies completed recruitment on time and without serious adverse events.
Conclusions
The protocol was feasible in clinical settings. The findings and experiences documented
in this report could be useful for future protocols.
Keywords
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Article info
Publication history
Published online: September 26, 2020
Accepted:
July 20,
2020
Received:
January 15,
2020
Footnotes
Conflicts of interest: The authors have no financial relationships relevant to this article to disclose.
Clinical trials registry site and number: Boston Children's Hospital NCT0298184.
Identification
Copyright
© 2020 Society for Adolescent Health and Medicine. All rights reserved.
