Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change from baseline in frequency of substance.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Full Access to the relapse prevention program
The participants will receive access to the relapse prevention program throughout the entire 6-week trial period.
干预措施: Relapse prevention program (Behavioral)
TAU
The participants will receive treatment as usual (TAU) for 6-weeks, and will receive access to the relapse prevention program after the completion of the 6 month follow-up.
干预措施: Relapse prevention program (Behavioral)
结局指标
主要结局
Change from baseline in frequency of substance.
时间窗: (1) within one week prior to the 6-week trial (baseline), (2) within one week of the end of the trial (end-point), and (3) 3 or 6 months after completion of the trial period (follow-up)
As directed by the contract, the investigators will use the NIDA Common Data Element Timeline Follow-Back measure (TLFB; Sobell \& Sobell, 1992) for self-report. Adolescents will complete the TLFB reporting past 30 day use. Adolescents will be presented with a calendar showing the previous 30 days and will be asked to indicate whether or not they used substances each day. For days in which either alcohol or tobacco use is indicated, adolescents will be asked to report the quantity used. The investigators will also measure substance use with a toxicology report. The participant will submit an oral swab for toxicology screening directly to the third-party laboratory, LabCorp, which will evaluate oral swabs for 10 different substances. After the results have been read, the toxicology analyses will be emailed to study staff with the de-identified study number.
次要结局
- Change from baseline in perceived benefits of substance use.((1) within one week prior to the 6-week trial (baseline), (2) within one week of the end of the trial (end-point), and (3) 3 or 6 months after completion of the trial period (follow-up))
- Change from baseline in self-efficacy to avoid substance use.((1) within one week prior to the 6-week trial (baseline), (2) within one week of the end of the trial (end-point), and (3) 3 or 6 months after completion of the trial period (follow-up))
- Change from baseline in Readiness of Change.((1) within one week prior to the 6-week trial (baseline), (2) within one week of the end of the trial (end-point), and (3) 3 or 6 months after completion of the trial period (follow-up))
- Change from baseline in coping behaviors.((1) within one week prior to the 6-week trial (baseline), (2) within one week of the end of the trial (end-point), and (3) 3 or 6 months after completion of the trial period (follow-up))
- Change from baseline in knowledge of substance abuse recovery and relapse.((1) within one week prior to the 6-week trial (baseline), (2) within one week of the end of the trial (end-point), and (3) 3 or 6 months after completion of the trial period (follow-up))