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

Inflexxion

Status and phase: Completed; Phase 2

Conditions: Substance-Related Disorders

Treatments: Behavioral: Attention Control; Behavioral: Navigating my Journey program

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02125539

NMJ 2R44DA026645-02A1

2R44DA026645-02A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Navigating my Journey program

Experimental group

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.

Treatment:

Behavioral: Navigating my Journey program

Attention Control

Active Comparator group

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.

Treatment:

Behavioral: Attention Control