Substance-Related DisordersARISENCT02715557
Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers
A study testing Relapse prevention program in people with Substance-Related Disorders, run by 3-C Institute for Social Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Relapse prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
3-C Institute for Social Development, dba 3C Institute
Durham, North Carolina, 27713
About this study
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.
Read the 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.
- Conditions
- Substance-Related Disorders
- Being tested
- Relapse prevention program
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relapse prevention programBehavioural
The relapse prevention program is an innovative computer-based coping skills educational program for adolescent substance abuse treatment completers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Relapse prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (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.
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.
Measured: (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.
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.
Measured: (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.
In this 5-item measure, adolescents report the extent to which they believe there are favorable aspects to substance use.
Measured: (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.
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.
Measured: (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.
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.
Measured: (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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-C Institute for Social Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meghan Scrimgeour, Ph.D., Principal investigator, 3-C Institute for Social Development, dba 3C InstituteMelissa E DeRosier, PhD, Principal investigator, 3-C Institute for Social Development, dba 3C Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715557
- Sponsor's protocol ID
- HHSN27120140075C
- Acronym
- ARISE
- Status last verified
- Jan 2018
- First submitted
- 17 Mar 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers
- ClinicalTrials.gov ID
- NCT02715557
- Acronym / sponsor ID
- ARISE / HHSN27120140075C
- Conditions
- Substance-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- 3-C Institute for Social DevelopmentIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Access to the relapse prevention program | Experimental | Behavioral: Relapse prevention programThe participants will receive access to the relapse prevention program throughout the entire 6-week trial period. |
| TAU | Experimental | Behavioral: Relapse prevention programThe 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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relapse prevention programThe relapse prevention program is an innovative computer-based coping skills educational program for adolescent substance abuse treatment completers. | Behavioural | Full Access to the relapse prevention program, TAU |
Primary outcome
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan Scrimgeour, Ph.D. principal investigator
3-C Institute for Social Development, dba 3C Institute
Melissa E DeRosier, PhD principal investigator
3-C Institute for Social Development, dba 3C Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relapse prevention program in people with Substance-Related Disorders, run by 3-C Institute for Social Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.