Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers

Purpose:

In Phase I of this SBIR project, 3C Institute (3C) developed a working prototype of an
innovative computer-based coping skills educational program for adolescent substance abuse
treatment completers. For Phase I, 3C developed and tested two customizable intelligent
educational modules to teach coping skills in order to help adolescents avoid relapse, along
with a brief instructional game for each segment. The Phase I prototype also included an
online Parent Guide to inform parents about the uses and benefits of the product. Phase I R&D
provided strong support for the quality and value of the prototype as well as the viability
of the proposed educational package and its promise for preventing substance abuse relapse
with adolescents. Phase I results supported excellent quality of the product through high
ratings of quality, appeal, and value. High feasibility and usability was also demonstrated
through high ratings for ease of use, usability, and potential effectiveness.

The goal of this Phase II SBIR project is to modify and expand the relapse prevention program
developed in Phase I in response to customer feedback and to evaluate the efficacy of the
full program with an RCT pilot clinical study. This product will be an adaptable software
program for aftercare therapy. In Phase II, the investigators will build on the Phase I
findings to modify and extend the existing content and develop the full program, which will
include: an introductory module as well as interactive lessons and skill-building games for
five coping skills modules. The Phase II product will also include a HelpCenter to support
sustained, quality use of the product during commercialization.

Research Design:

Throughout development and iterative usability testing, the project consultants, experts in
the field of adolescent substance abuse treatment and prevention, will review and interact
with the relapse prevention program, and results will be used to modify and finalize the user
interface and navigation to maximize usability prior to pilot testing with adolescents. Once
all revisions and additions have been completed and integrated into the fully functioning
product, the investigators will conduct an RCT pilot clinical study with up to 125
adolescents aged 13 - 19 years in substance abuse recovery to evaluate the benefits and
effectiveness of the program. The investigators will use a rolling enrollment randomized
control design in which adolescents will be randomly assigned to one of two conditions: (a)
Group A, in which participants will receive access to the relapse prevention program
throughout the entire 6-week trial period, or (b) Group B, in which participants will receive
treatment as usual (TAU) for 6-weeks, and will receive access to the relapse prevention
program following the completion of all data collection. Over the trial, the following
outcome areas will be assessed: substance use and cravings, substance abuse recovery and
relapse knowledge, perceived benefits of substance use, coping behaviors and coping, stage of
change, and treatment as usual description. The investigators will also assess usability and
acceptability of the program and gather information on adverse events/serious adverse events
that occur during interaction with the program.

Hypotheses:

Based on Phase I findings and 3C's experience developing similar products, the investigators
expect high user ratings on the relapse prevention program, and anticipate greater
improvement in outcomes across all areas for adolescents who received access to the relapse
prevention program (Group A) compared with those who did not (Group B), providing evidence
for the promise of this new educational program for generating beneficial substance use
abstinence outcomes. The investigators do not expect participation in the program to be
associated with any negative outcomes. The investigators expect Phase II findings to
demonstrate greater sobriety maintenance for adolescents with access to the relapse
prevention program compared to those in typical aftercare activities.

Length of Study:

The investigators anticipate the pilot phase of this study, including recruitment, conducting
the pilot RCT, and collecting follow-up data to last 17 months.

Confidentiality:

Due to the sensitive nature of this study, the investigators have obtained a Certificate of
Confidentiality from NIDA. The Certificate number is CC-DA-16-061, and is valid from
9/17/2014 - 9/17/2018.

Inclusion Criteria:

- Aged 13 - 19 years at time of enrollment

- Met DSM-5 criteria for any substance use disorder preceding primary treatment

- Completed substance abuse treatment within 90 days prior to the start of the trial

- Proficient in reading and writing English

- Access to a computer or tablet with high-speed internet