Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03258905 |
| Other study ID # |
R44AA026746-02A1 |
| Secondary ID |
R44AA026746-02A1 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2019 |
| Est. completion date |
September 3, 2020 |
Study information
| Verified date |
December 2021 |
| Source |
Treatment Innovations |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this project is to continue to develop a smartphone application ("app") to help
youth from ages 18-25 who have a substance abuse problem. The app will engage them in
grounding, which is a sensory-based experience to help them feel calm by reducing intense
negative feelings and impulses (such as the urge to use a substance or hurt themselves or
others).
Description:
Substance use disorder (SUD) is the second most common psychiatric diagnosis in the U.S.
population. Transition-age youth (TAY) from ages 18-25 are especially vulnerable to substance
use and SUD. This time period represents a distinct stage separate from adolescence and later
adulthood. It includes tasks such as leaving home to enter college, the workforce, or the
military; clarifying vocational goals; and attaining legal drinking age. This period is also
prime for experimentation with substance use and associated risks such as driving under the
influence, accidents, fighting and violence, HIV, and vulnerability to sexual assault. This
project focused on a major strategy, grounding, to help TAY de-escalate (reduce) intense
negative emotions and impulses. Grounding has long been used in psychiatric hospitals to
provide a safe, quick, and powerful way to reduce any intense negative feeling such as
impulses to hurt self or others, substance craving, anger, anxiety, etc. Described in detail
in the book Seeking Safety (SS), grounding using three pathways to focus the mind (mental),
body (physical), and heart (soothing). Grounding provides a way to regulate emotion, which is
a major challenge for TAY, especially given their hormone changes and emotional intensity.
Indeed substance use is often described as a short-term way to regulate emotion. Grounding is
a key module of SS, a widely-implemented, evidence-based SUD treatment model. In phase 1 the
investigator developed a beta version of a grounding app. The app promotes the use of
grounding in any environment in which emotions and impulses need to be regulated. It
capitalizes on TAYs' widespread use of mobile devices; and because grounding is a stand-alone
skill and sensory-oriented, it lends itself wonderfully to an app approach. An iterative
product development methodology was used based on end-user feedback and the impact of the app
was studied in a pilot randomized controlled trial (RCT) with 24 TAY. Half received the app
and the other half received grounding handouts. Results showed that the app was consistently
more positively rated than the handouts and was associated with significantly more use of
grounding and a higher score on a grounding knowledge test. All phase 1 benchmarks were met.
In phase 2 the investigator proposes to scale up both the app and the evaluation of it. There
are two specific aims: (1) To enhance the mobile grounding app by using exciting, innovative
technology approaches as well as expanding the grounding content in amount and type. (2) To
conduct an RCT with 68 TAY to evaluate the grounding app versus a control app. The control
app would control for both the use of a mobile device and the grounding content. The primary
outcome is based on power analysis from the phase 1 pilot; other outcomes and measures are
also included. The RCT uses rigorous scientific methods in its design, measures, and
statistics.
