Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Relapse prevention program
Intervention type(s): Behavioral
Intervention description(s): The relapse prevention program is an innovative computer-based coping skills educational program for adolescent substance abuse treatment completers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care