Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03551886 |
Other study ID # |
2R44DA042640-02 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2020 |
Est. completion date |
March 1, 2022 |
Study information
Verified date |
April 2022 |
Source |
Treatment Innovations |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Transition-age youth (TAY) from ages 18-26 are vulnerable to substance substance use disorder
(SUD). This developmental period, termed "emerging adulthood" includes leaving home, entering
college or working for the first time; and for some, aging out of foster care or state
custody, which end at age 18. The emerging-adulthood period is prime for experimentation with
substances and the development of SUD, and associated problems. A major challenge for TAY is
the capacity to regulate their emotions, given the hormone changes and emotional intensity of
this stage of life. Indeed, substance use can be a short-term way to regulate emotion. The
importance of ER is identified as a core skill that is critical to the successful transition
to adulthood. The initial component of ER, accurate identification of emotion, is itself a
major challenge. In the phase 1 project a mobile app was developed that uses automated
emotion detection to help TAY better recognize their emotions in relation to SUD. We found
positive results in our phase 1 study. Phase 2 will see the continuation of the development
of the app features. Phase 2 also includes a randomized controlled trial to evaluate the app
among TAY with SUD in their natural environment, such as home, and we will conduct pre- and
post-evaluation to compare outcomes between the app condition and a control-app condition.
The primary outcomes are substance use and emotion regulation. User satisfaction, feedback at
the end of phase 2 and app metrics will also be explored. The app can potentially have major
public health and clinical impact. It could help improve TAY's ability to become more aware
of emotions and understand them in relation to SUD via emotion-focused technoloy. If the
product is successful it could be expanded to other populations.
Description:
Transition-age youth (TAY) from ages 18-26 are especially vulnerable to substance use,
misuse, and substance use disorder (SUD). This developmental period, termed the "age of
instability" and "emerging adulthood" includes tasks such as leaving home, entering college;
identifying vocational goals; working for the first time; body and sexuality changes;
coalescing with a peer group; and for some, aging out of foster care or state custody, which
end at age 18. The emerging-adulthood period is prime for experimentation with substances and
the development of SUD, and associated problems such as binge drinking, driving under the
influence, accidents, fighting and violence, HIV, gang involvement, suicide and self-harm,
and vulnerability to date-rape and other sexual assault. A major challenge for TAY is the
capacity to regulate their emotions, given the hormone changes and emotional intensity of
this stage of life. Indeed, substance use is often described as a short-term way to regulate
emotion and there is a long-standing literature documenting the association between emotion
regulation (ER) problems and SUD. The importance of ER is also grounded in the developmental
literature in which ER is identified as a core skill that is critical to the successful
transition to adulthood. The initial component of ER, accurate identification of emotion, is
itself a major challenge, especially for people with SUD as they are often not aware of their
feelings or confused about them due to the nature of the disorder as well as mental health
disorders that often co-occur with SUD. The phase 1 project developed and evaluated a mobile
app that uses exciting new technology (automated emotion detection) to help TAY better
recognize their emotions in relation to SUD variables. Highly positive results were found in
the phase 1 feasibility / pilot study and are now proposing a phase 2 project to continue
this work. In phase 2 the app will continue to be developed based on user experience based on
end-user feedback and an expert consultant team. Phase 2 also includes a randomized
controlled trial to evaluate the app among TAY with SUD. They will have six weeks to use the
app in their natural environment, such as home, and will complete pre- and post-evaluation
using validated instrumts to compare outcomes between two conditions: the app condition and a
control-app condition. The primary outcomes are substance use and emotion regulation.
End-user satisfaction with the app will also be obtained as well as app metrics. The app
product could have major public health and clinical impact. It could help improve TAY's
ability to become more aware of their emotions and understand them in relation to SUD via an
exciting emotion-focused technology innovation. If the product is successful it could also be
expanded to other populations. The collaborative team includes experts in SUD, TAY, clinical
innovations, technology, and app development.