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Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers

2016-03-23 07:08:23 | BioPortfolio

Summary

In Phase I of this SBIR project, 3C Institute (3C) developed a working prototype of For Life (henceforth Arise), 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 for Arise 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 Arise 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 Arise 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.

Description

Purpose:

In Phase I of this SBIR project, 3C Institute (3C) developed a working prototype of For Life (henceforth Arise), 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 for Arise 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 Arise 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 Arise 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 Arise, 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 15 - 17 years in substance abuse recovery to evaluate the benefits and effectiveness of Arise. The investigators will use a rolling enrollment staggered entry design in which adolescents will be randomly assigned to one of two conditions: (a) Group A, in which participants will receive access to Arise throughout the entire 12-week trial period, or (b) Group B, in which participants will receive treatment as usual (TAU) for 6-weeks, followed by access to Arise starting at the midpoint of the 12-week trial period. 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 Arise 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 Arise product, and anticipate improvement in outcomes across all areas to be synchronized with date of access to Arise, 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 Arise 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 6-month 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Substance-Related Disorders

Intervention

Arise

Location

3-C Institute for Social Development, dba 3C Institute
Durham
North Carolina
United States
27713

Status

Recruiting

Source

3-C Institute for Social Development

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-03-23T07:08:23-0400

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