Clinical trial NCT02125539: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance-Related Disorders
Keywords: Online adolescent substance abuse relapse prevention program
Lead sponsor: Inflexxion, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-04-29
Enrollment: 160
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Substance Use Across Time
timeFrame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
measure: Change in Motivation to Change Across Time
timeFrame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
measure: Change in Self-Efficacy Across Time
timeFrame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
measure: Change on the Adolescent Relapse Coping Questionnaire (ARCQ) Across Time
timeFrame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Secondary outcomes:
measure: Change in Therapeutic Alliance Across Time
timeFrame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
measure: Client Satisfaction
timeFrame: 3 months post baseline
measure: Change in Client Engagement/Attendance Across time
timeFrame: 1 month post baseline and 6 months post baseline
measure: Counselor Satisfaction
timeFrame: 3 months post baseline
Other outcomes:
Locations:
city: Newton
country: United States
facility: Inflexxion, Inc.
state: Massachusetts
Study officials:
affiliation: Inflexxion, Inc.
name: Kimberlee Trudeau, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: