Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers

Substance-Related Disorders Clinical Trial

— ARISE  

Official title:

Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715557
• Other study ID #: HHSN27120140075C
• Status: Completed
• Phase: N/A
• First received: March 17, 2016
• Last updated: January 10, 2018
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: 3-C Institute for Social Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Behavioral:
• Relapse prevention program
The relapse prevention program is an innovative computer-based coping skills educational program for adolescent substance abuse treatment completers.

Locations

Country	Name	City	State
United States	3-C Institute for Social Development, dba 3C Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
3-C Institute for Social Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in frequency of substance.	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.	(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)
Secondary	Change from baseline in coping behaviors.	Participants will complete the Coping Behaviors Inventory: (CBI; Litman, Stapleton, Oppenheim, & Peleg, 1983; additional items added by Dr. Sanchez) to report how often they have used a variety of coping skills using this 44-item self-report measure designed to assess coping skills among adolescents with a history of alcohol and other drug abuse.	(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)
Secondary	Change from baseline in knowledge of substance abuse recovery and relapse.	This investigator-created 20 item measure assesses knowledge of substance abuse relapse risk and prevention and is based on the substance abuse recovery and relapse literature and established measures that have been used to assess 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)
Secondary	Change from baseline in perceived benefits of substance use.	In this 5-item measure, adolescents report the extent to which they believe there are favorable aspects to 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)
Secondary	Change from baseline in self-efficacy to avoid substance use.	Adolescents will complete the Drug Avoidance Self-Efficacy Scale (Martin, G.W., Wilkinson, D.A., & Poulos, C.X., 1995) a 16-item measure of 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)
Secondary	Change from baseline in Readiness of Change.	Adolescents will complete the 12-item Readiness to Change Questionnaire (Heather, N., & Honekopp, J., 2008) indicating their current stage of change in substance use abstinence.	(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)