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Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Navigating my Journey program
Attention Control
Sponsored by
Inflexxion, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring Online adolescent substance abuse relapse prevention program

Eligibility Criteria

13 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • currently meeting with a counselor in the study at least twice per month during the next 3 months
  • age 13 to 21
  • ability to read and speak English
  • have drugs and/or alcohol as their primary or secondary substance used
  • have completed detox as necessary
  • an active email account.

Sites / Locations

  • Inflexxion, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Navigating my Journey program

Attention Control

Arm Description

Client participants of counselors who were randomized to the experimental condition will receive the following intervention: The online Navigating my Journey relapse prevention program is an adjunct to outpatient treatment. We will ask client participants to complete at least 12 Navigating my Journey sessions and discuss them with their counselors.

Client participants of counselors who were randomized to the control condition will receive their typical course of counseling and a link to online online health information in PDF form as an attention control.

Outcomes

Primary Outcome Measures

Change in Substance Use Across Time
Participants will be asked how many days in the past 30 days they used a variety of substances, including alcohol. This self report question format is widely used to assess substance use (e.g., the GPRA from CSAT; SAMHSA, 2010).
Change in Motivation to Change Across Time
The 32-item University of Rhode Island Change Assessment Questionnaire (URICA; McConnaughy et al., 1983, 1989) will be used to measure motivation to change. It has four 8-item scales (Precontemplation, Contemplation, Action, and Maintenance) that can be combined to create a single Readiness to Change score (C + A + M - PC = Readiness). Participants rate each item 1=Strongly Disagree to 5=Strongly Agree. This scale has good reliability and validity with adolescents (Greenstein et al., 1999).
Change in Self-Efficacy Across Time
Drug Avoidance Self-Efficacy Scale (DASES). The DASES (Martin et al., 1995) assesses one's current self-efficacy to resist drug use in hypothetical high-risk situations. The scale contains 16 items, and responses are rated on a 7-point scale ranging from "certainly yes" to "certainly no."
Change on the Adolescent Relapse Coping Questionnaire (ARCQ) Across Time
The ARCQ (Myers et al., 2006) assesses "temptation coping responses among adolescents." It begins with a short assessment of appraisal (5 items total) of a situation where peers are drinking and using, followed by 28 items rated between 1 = Definitely would not do or think, through 7 = Definitely would do or think. These 28 items comprise three subscales: Cognitive and behavioral problem solving (e.g., Let your feelings out somehow; alpha = .82); Self-critical thinking (e.g., Criticize or lecture yourself; alpha = .80); and Abstinence-focused coping (e.g., Leave or avoid the situation; alpha = .78).

Secondary Outcome Measures

Change in Therapeutic Alliance Across Time
Working Alliance Inventory-Short Form (Clients) (WAI-S). The working alliance between counselor and client is a critical indicator of client outcomes. The WAI-S (Tracey & Kokotovic, 1989) is a short form (12 items) of the original WAI (36 items). It has three sub-scales - therapeutic bond, agreement on tasks, and agreement about goals. Items are scored on a 7-point scale (1 = rarely to 7 = always, range 12-84).
Client Satisfaction
At the end of the study, participants will be asked to evaluate the resources they reviewed (i.e., attention control materials or Navigating my Journey program) and their experience in the study. Because this survey is dependent on content and features which will have been developed in Phase II, it will be fully developed at that time. We expect that participants will rate the program's usability (ease of navigation, information organization, and graphical interface) and content (relevance, interest, comprehension) on a 5-point Likert scale (1 = not at all to 5 = extremely). Examples of questions that may be included are: To what degree were these resources helpful in your treatment? How helpful were these resources in preparing you to deal with the challenges you face in recovery? How helpful these resources in keeping you involved in treatment?
Change in Client Engagement/Attendance Across time
Counselors will be asked to fill out a form to indicate if the client is still in treatment at the center and if so, how many sessions each participant attended since the last status update. If the client is no longer receiving treatment at the center, we will ask why the participant is not still in treatment at the center and if there were any other factors affecting their discharge. Each form is expected to take less than 10 minutes.
Counselor Satisfaction
At the end of the study, counselors will be asked to evaluate the resources they viewed and their experience in the study via an online questionnaire and phone interview. These activities will take a maximum of 60 minutes. Participants will rate (1) the degree to which these resources helped to make improvements in their clients' outcomes; (3) the effectiveness of these resources in dealing with the challenges of recovery; (4) overall, what they thought of these resources; (5) the ability of these resources to engage their substance abuse clients; (6) how likely they are to recommend these resources to a colleague; and (7) what improvements they would recommend to make these resources better to help in substance abuse treatment. Feedback from counselors in the experimental condition will be used to make modifications to Navigating my Journey before marketing occurs.

Full Information

First Posted
April 21, 2014
Last Updated
July 24, 2015
Sponsor
Inflexxion, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02125539
Brief Title
Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment
Official Title
Navigating My Journey (NmJ): A Relapse Prevention Program for Adolescents -- Field Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inflexxion, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to provide a comprehensive evaluation of the new, Navigating my Journey program for adolescents receiving treatment in an outpatient substance abuse center. The primary hypotheses are that, relative to the control condition, Navigating my Journey will be associated with significantly higher motivation, higher self-efficacy, improved relapse coping skills, and lower substance use. The secondary hypotheses are that, relative to the control condition, Navigating my Journey will be associated with increased therapeutic alliances with counselors.
Detailed Description
The randomized, control trial will compare clients receiving treatment in an outpatient substance abuse center in the following two conditions -- (1) Experimental: Navigating my Journey (includes 12 core lessons and 8 supplemental lessons); and (2) Attention Control (treatment as usual plus online health information) -- using a longitudinal design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
Online adolescent substance abuse relapse prevention program

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navigating my Journey program
Arm Type
Experimental
Arm Description
Client participants of counselors who were randomized to the experimental condition will receive the following intervention: The online Navigating my Journey relapse prevention program is an adjunct to outpatient treatment. We will ask client participants to complete at least 12 Navigating my Journey sessions and discuss them with their counselors.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
Client participants of counselors who were randomized to the control condition will receive their typical course of counseling and a link to online online health information in PDF form as an attention control.
Intervention Type
Behavioral
Intervention Name(s)
Navigating my Journey program
Intervention Description
The online relapse prevention program called Navigating my Journey is designed for adolescents who are receiving outpatient treatment for substance abuse. Since the Navigating my Journey program will be available to adolescents 24/7, it is easy for them to access at their convenience. The program functions as an adjunct to treatment and is designed to complement and enhance the work the adolescent does with the counselor during counseling sessions. The core intervention is expected to last for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
Client participants in the control group will receive their typical course of counseling and a link to online online health information in PDF form as an attention control.
Primary Outcome Measure Information:
Title
Change in Substance Use Across Time
Description
Participants will be asked how many days in the past 30 days they used a variety of substances, including alcohol. This self report question format is widely used to assess substance use (e.g., the GPRA from CSAT; SAMHSA, 2010).
Time Frame
Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Title
Change in Motivation to Change Across Time
Description
The 32-item University of Rhode Island Change Assessment Questionnaire (URICA; McConnaughy et al., 1983, 1989) will be used to measure motivation to change. It has four 8-item scales (Precontemplation, Contemplation, Action, and Maintenance) that can be combined to create a single Readiness to Change score (C + A + M - PC = Readiness). Participants rate each item 1=Strongly Disagree to 5=Strongly Agree. This scale has good reliability and validity with adolescents (Greenstein et al., 1999).
Time Frame
Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Title
Change in Self-Efficacy Across Time
Description
Drug Avoidance Self-Efficacy Scale (DASES). The DASES (Martin et al., 1995) assesses one's current self-efficacy to resist drug use in hypothetical high-risk situations. The scale contains 16 items, and responses are rated on a 7-point scale ranging from "certainly yes" to "certainly no."
Time Frame
Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Title
Change on the Adolescent Relapse Coping Questionnaire (ARCQ) Across Time
Description
The ARCQ (Myers et al., 2006) assesses "temptation coping responses among adolescents." It begins with a short assessment of appraisal (5 items total) of a situation where peers are drinking and using, followed by 28 items rated between 1 = Definitely would not do or think, through 7 = Definitely would do or think. These 28 items comprise three subscales: Cognitive and behavioral problem solving (e.g., Let your feelings out somehow; alpha = .82); Self-critical thinking (e.g., Criticize or lecture yourself; alpha = .80); and Abstinence-focused coping (e.g., Leave or avoid the situation; alpha = .78).
Time Frame
Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Secondary Outcome Measure Information:
Title
Change in Therapeutic Alliance Across Time
Description
Working Alliance Inventory-Short Form (Clients) (WAI-S). The working alliance between counselor and client is a critical indicator of client outcomes. The WAI-S (Tracey & Kokotovic, 1989) is a short form (12 items) of the original WAI (36 items). It has three sub-scales - therapeutic bond, agreement on tasks, and agreement about goals. Items are scored on a 7-point scale (1 = rarely to 7 = always, range 12-84).
Time Frame
Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Title
Client Satisfaction
Description
At the end of the study, participants will be asked to evaluate the resources they reviewed (i.e., attention control materials or Navigating my Journey program) and their experience in the study. Because this survey is dependent on content and features which will have been developed in Phase II, it will be fully developed at that time. We expect that participants will rate the program's usability (ease of navigation, information organization, and graphical interface) and content (relevance, interest, comprehension) on a 5-point Likert scale (1 = not at all to 5 = extremely). Examples of questions that may be included are: To what degree were these resources helpful in your treatment? How helpful were these resources in preparing you to deal with the challenges you face in recovery? How helpful these resources in keeping you involved in treatment?
Time Frame
3 months post baseline
Title
Change in Client Engagement/Attendance Across time
Description
Counselors will be asked to fill out a form to indicate if the client is still in treatment at the center and if so, how many sessions each participant attended since the last status update. If the client is no longer receiving treatment at the center, we will ask why the participant is not still in treatment at the center and if there were any other factors affecting their discharge. Each form is expected to take less than 10 minutes.
Time Frame
1 month post baseline and 6 months post baseline
Title
Counselor Satisfaction
Description
At the end of the study, counselors will be asked to evaluate the resources they viewed and their experience in the study via an online questionnaire and phone interview. These activities will take a maximum of 60 minutes. Participants will rate (1) the degree to which these resources helped to make improvements in their clients' outcomes; (3) the effectiveness of these resources in dealing with the challenges of recovery; (4) overall, what they thought of these resources; (5) the ability of these resources to engage their substance abuse clients; (6) how likely they are to recommend these resources to a colleague; and (7) what improvements they would recommend to make these resources better to help in substance abuse treatment. Feedback from counselors in the experimental condition will be used to make modifications to Navigating my Journey before marketing occurs.
Time Frame
3 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: currently meeting with a counselor in the study at least twice per month during the next 3 months age 13 to 21 ability to read and speak English have drugs and/or alcohol as their primary or secondary substance used have completed detox as necessary an active email account.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberlee Trudeau, Ph. D.
Organizational Affiliation
Inflexxion, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inflexxion, Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02464
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment

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