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Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers (ARISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715557
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
3-C Institute for Social Development

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.


Condition or disease Intervention/treatment Phase
Substance-Related Disorders Behavioral: Relapse prevention program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers
Study Start Date : September 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

Arm Intervention/treatment
Experimental: Full Access to the relapse prevention program
The participants will receive access to the relapse prevention program throughout the entire 6-week trial period.
Behavioral: Relapse prevention program
The relapse prevention program is an innovative computer-based coping skills educational program for adolescent substance abuse treatment completers.

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




Primary Outcome Measures :
  1. Change from baseline in frequency of substance. [ Time Frame: (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.


Secondary Outcome Measures :
  1. Change from baseline in coping behaviors. [ Time Frame: (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) ]
    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.

  2. Change from baseline in knowledge of substance abuse recovery and relapse. [ Time Frame: (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) ]
    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.

  3. Change from baseline in perceived benefits of substance use. [ Time Frame: (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) ]
    In this 5-item measure, adolescents report the extent to which they believe there are favorable aspects to substance use.

  4. Change from baseline in self-efficacy to avoid substance use. [ Time Frame: (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) ]
    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.

  5. Change from baseline in Readiness of Change. [ Time Frame: (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) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715557


Locations
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United States, North Carolina
3-C Institute for Social Development, dba 3C Institute
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
3-C Institute for Social Development
Investigators
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Principal Investigator: 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
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Responsible Party: 3-C Institute for Social Development
ClinicalTrials.gov Identifier: NCT02715557    
Other Study ID Numbers: HHSN27120140075C
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders