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

NCT ID: NCT02125539

Last Updated: 2015-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Navigating my Journey program

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.

Group Type EXPERIMENTAL

Navigating my Journey program

Intervention Type 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.

Attention Control

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.

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Inflexxion, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberlee Trudeau, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Inflexxion, Inc.

Locations

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Inflexxion, Inc.

Newton, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2R44DA026645-02A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NMJ 2R44DA026645-02A1

Identifier Type: -

Identifier Source: org_study_id

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