Ignite Creation Date:
2024-05-06 @ 8:18 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02715557
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2016-03-17
Brief Title:
Arise An Online Relapse Prevention Tool for Adolescent Substance Abusers
Sponsor:
3-C Institute for Social Development
Organization:
3-C Institute for Social Development
Study Overview
Official Title:
Arise An Online Relapse Prevention Tool for Adolescent Substance Abusers
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARISE
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 RD 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
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 RD 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 eventsserious adverse events that occur during interaction with the program
Hypotheses
Based on Phase I findings and 3Cs 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 9172014 - 9172018
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 RD 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 eventsserious adverse events that occur during interaction with the program
Hypotheses
Based on Phase I findings and 3Cs 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 9172014 - 9172018
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None