Substance-Related DisordersPhase 2NCT02125539
Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment
A Phase 2 study testing Navigating my Journey program in people with Substance-Related Disorders, run by Inflexxion, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Navigating my Journey program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Navigating My Journey (NmJ): A Relapse Prevention Program for Adolescents -- Field Trial
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.
Read the 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.
- Conditions
- Substance-Related Disorders
- Being tested
- Navigating my Journey program, Attention Control
- Keywords
- Online adolescent substance abuse relapse prevention program
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigating my Journey programBehavioural
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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."
Measured: 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).
Measured: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Secondary outcomes (4)
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).
Measured: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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?
Measured: 3 months post baseline
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.
Measured: 1 month post baseline and 6 months post baseline
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.
Measured: 3 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflexxion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kimberlee Trudeau, Ph. D., Principal investigator, Inflexxion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125539
- Sponsor's protocol ID
- NMJ 2R44DA026645-02A1
- Other IDs
- 2R44DA026645-02A1
- Status last verified
- Jun 2015
- First submitted
- 21 Apr 2014
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating My Journey (NmJ): A Relapse Prevention Program for Adolescents -- Field Trial
- ClinicalTrials.gov ID
- NCT02125539
- Acronym / sponsor ID
- NMJ 2R44DA026645-02A1
- Conditions
- Substance-Related Disorders
- Keywords
- Online adolescent substance abuse relapse prevention program
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Inflexxion, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigating my Journey program | Experimental | Behavioral: Navigating my Journey programClient 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. |
| Attention Control | Active comparator | Behavioral: Attention ControlClient 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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigating my Journey programThe 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. | Behavioural | Navigating my Journey program |
| Attention ControlClient 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. | Behavioural | Attention Control |
Primary outcome
Change in Substance Use Across Time
Time frame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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).
Change in Motivation to Change Across Time
Time frame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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).
Change in Self-Efficacy Across Time
Time frame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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."
Change on the Adolescent Relapse Coping Questionnaire (ARCQ) Across Time
Time frame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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).
4 secondary outcomes
Change in Therapeutic Alliance Across Time
Time frame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Client Satisfaction
Time frame: 3 months post baseline
Change in Client Engagement/Attendance Across time
Time frame: 1 month post baseline and 6 months post baseline
Counselor Satisfaction
Time frame: 3 months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberlee Trudeau, Ph. D. principal investigator
Inflexxion, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Navigating my Journey program in people with Substance-Related Disorders, run by Inflexxion, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Substance Use Across Time (time frame: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.