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

NCT02125539 | Completed Phase 2 DMC

• 2 other identifiers: NMJ 2R44DA026645-02A12R44DA026645-02A1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders

Keywords

Online adolescent substance abuse relapse prevention program

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (4)

• Change in Therapeutic Alliance Across Time

  Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline

• Client Satisfaction

  3 months post baseline

• Change in Client Engagement/Attendance Across time

  1 month post baseline and 6 months post baseline

• Counselor Satisfaction

  3 months post baseline

Study Arms (2)

Navigating my Journey program

EXPERIMENTAL

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.

Behavioral: Navigating my Journey program

Attention Control

ACTIVE COMPARATOR

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.

Behavioral: Attention Control

Interventions

Navigating my Journey program BEHAVIORAL

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.

Navigating my Journey program

Attention Control BEHAVIORAL

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.

Attention Control

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Inflexxion, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Inflexxion, Inc.

Newton, Massachusetts, 02464, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kimberlee Trudeau, Ph. D.

  Inflexxion, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 29, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 27, 2015

Record last verified: 2015-06

Locations

US (1)