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

Substance-Related Disorders Clinical Trial

Official title:

Navigating My Journey (NmJ): A Relapse Prevention Program for Adolescents -- Field Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125539
• Other study ID #: NMJ 2R44DA026645-02A1
• Secondary ID: 2R44DA026645-02A
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2014
• Last updated: July 24, 2015
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Inflexxion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 21 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Behavioral:
• Navigating my Journey program
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.
• Attention Control
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.

Locations

Country	Name	City	State
United States	Inflexxion, Inc.	Newton	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Inflexxion, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline	No
Primary	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).	Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline	No
Primary	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."	Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline	No
Primary	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).	Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline	No
Secondary	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).	Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline	No
Secondary	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?	3 months post baseline	No
Secondary	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.	1 month post baseline and 6 months post baseline	No
Secondary	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.	3 months post baseline	No