- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02125539
Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment
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.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Massachusetts
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Newton, Massachusetts, 미국, 02464
- Inflexxion, Inc.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Substance Use Across Time
기간: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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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).
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Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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Change in Motivation to Change Across Time
기간: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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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).
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Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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Change in Self-Efficacy Across Time
기간: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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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."
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Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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Change on the Adolescent Relapse Coping Questionnaire (ARCQ) Across Time
기간: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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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).
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Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Therapeutic Alliance Across Time
기간: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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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).
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Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline
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Client Satisfaction
기간: 3 months post baseline
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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?
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3 months post baseline
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Change in Client Engagement/Attendance Across time
기간: 1 month post baseline and 6 months post baseline
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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.
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1 month post baseline and 6 months post baseline
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Counselor Satisfaction
기간: 3 months post baseline
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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.
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3 months post baseline
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Kimberlee Trudeau, Ph. D., Inflexxion, Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NMJ 2R44DA026645-02A1
- 2R44DA026645-02A1 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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