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

24 juli 2015 uppdaterad av: Inflexxion, Inc.

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

160

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Massachusetts
      • Newton, Massachusetts, Förenta staterna, 02464
        • Inflexxion, Inc.

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

13 år till 21 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
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.
Aktiv komparator: 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.
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Substance Use Across Time
Tidsram: 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).
Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Change in Motivation to Change Across Time
Tidsram: 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).
Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Change in Self-Efficacy Across Time
Tidsram: 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."
Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Change on the Adolescent Relapse Coping Questionnaire (ARCQ) Across Time
Tidsram: 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).
Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Therapeutic Alliance Across Time
Tidsram: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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).
Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
Client Satisfaction
Tidsram: 3 months post baseline
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?
3 months post baseline
Change in Client Engagement/Attendance Across time
Tidsram: 1 month post baseline and 6 months post baseline
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.
1 month post baseline and 6 months post baseline
Counselor Satisfaction
Tidsram: 3 months post baseline
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.
3 months post baseline

Samarbetspartners och utredare

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Utredare

  • Huvudutredare: Kimberlee Trudeau, Ph. D., Inflexxion, Inc.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2014

Primärt slutförande (Faktisk)

1 juni 2015

Avslutad studie (Faktisk)

1 juni 2015

Studieregistreringsdatum

Först inskickad

21 april 2014

Först inskickad som uppfyllde QC-kriterierna

25 april 2014

Första postat (Uppskatta)

29 april 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

27 juli 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juli 2015

Senast verifierad

1 juni 2015

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • NMJ 2R44DA026645-02A1
  • 2R44DA026645-02A1 (U.S.S. NIH-anslag/kontrakt)

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