Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers

NCT02715557 | Completed

• 1 other identifier: HHSN27120140075C
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• 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)

Study Arms (2)

Full Access to the relapse prevention program

EXPERIMENTAL

The participants will receive access to the relapse prevention program throughout the entire 6-week trial period.

Behavioral: Relapse prevention program

TAU

EXPERIMENTAL

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.

Behavioral: Relapse prevention program

Interventions

Relapse prevention program BEHAVIORAL

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

Full Access to the relapse prevention program; TAU

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• 3-C Institute for Social Development: lead

Study Sites (1)

3-C Institute for Social Development, dba 3C Institute

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Meghan Scrimgeour, Ph.D.

  3-C Institute for Social Development, dba 3C Institute

  PRINCIPAL INVESTIGATOR

• Melissa E DeRosier, PhD

  3-C Institute for Social Development, dba 3C Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

US (1)