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临床试验/NCT05358613
NCT05358613已完成不适用

Early Intervention Programs for at Risk Use of Psychoactive Substances and Gambling: ''My Choices'' Family

Université du Québec à Trois-Rivières10 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2021年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
167
试验地点
10
主要终点
Change in the Inventory of consequences associated with alcohol use

研究概览

简要总结

The aim of the study is to assess the efficacy of the My Choices - Alcohol program by comparing alcohol-use of people before and after doing the program to people that did not do the program on the same period of time (3 months).

详细描述

People with an alcohol addiction problem consume an average of 26.3 (sd = 12.4) drinks per week (Cournoyer et al., 2010). To observe a decrease of 25% in this average number of drinks for the group participating in the program " My Choices " immediately compared to the delayed group at 3 months, we need a sample size of 100 participants. This calculation assumes an alpha of 5%, a power of 80% and unbalanced groups due to the randomization method used. Considering an attrition rate of 11.3% at 3 months and 20% at 6 months (Tremblay et al., Submitted), it will be necessary to recruit at least 120 participants to maintain the required number for analyses.

References Cournoyer, L.-G., Simoneau, H., Landry, M., Tremblay, J., & Patenaude, C. (2010). Évaluation d'implantation du programme Alcochoix+ (FQRSC #2008-TO-120890). F. q. d. r. s. l. s. e. l. culture.

Tremblay, J., Dufour, M., Bertrand, K., Saint-Jacques, M., Ferland, F., Blanchette-Martin, N., Savard, A.-C., Côté, M., Berbiche, D., & Beaulieu, M. (Submitted). Efficacy of a Randomized Controlled Trial of Integrative Couple Treatment for Pathological Gambling (ICT-PG): 10-Month Follow-Up. Journal of Consulting and Clinical Psychology.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with at risk alcohol use (alcohol use over the Canadian low-risk alcohol drinking guidelines, without or with low consequences associated with their alcohol use).

排除标准

  • Score at the DEBA (Assessment and Screening of Assistance needs) indicates a need for specialized treatment.
  • Hospitalization for mental health problems in the last 30 days
  • People with unstable mental health condition

结局指标

主要结局

Change in the Inventory of consequences associated with alcohol use

时间窗: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

It is a 7-items questionnaire, with a 0-10 (Never to always) scale that measures the consequences of alcohol consumption.

Change in the Severity of dependence scale (SDS)

时间窗: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

The Severity of Dependence Scale (SDS) is a 5-item self-administered questionnaire that provides a score indicating the severity of dependence on drugs with a 4-point scale from 0 (Never) to 3 (Always). Score 0 indicates no dependence, score between 1-2 indicates low dependence, score between 3-5 indicates moderate dependance and score between 6 and 15 indicates a high dependance.

Change in self-reports of alcohol with the time-line follow-back (TLFB) in the last 90 days

时间窗: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

The timeline follow-Back is a research tool to obtain self-reported quantitatives estimates of alcohol used every day in the last 3 months in term of standard drink. (Sobell \& Sobell) Participants are asked in the first interview (2 weeks within eligibility evaluation) to remember day by day how many standard drinks they have had in the last 90 days.

Change in the Short Alcohol Dependance Data Questionnaire (SADD)

时间窗: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

Short Alcohol Dependence Data questionnaire (SADD) is used to measure the severity of alcohol dependence. It comprises 15 items with a four-point frequency scale (never,sometimes, often, nearly always). A total score between 0 and 45 is obtained by adding the score from each of the items. Scores between 0 - 9 indicates low dependence, scores between 10 - 19 indicates medium dependence and a score of 20 or more indicates high dependence.

次要结局

  • Medical Outcomes Study-Social Support Survey (MOS-SSS)(2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th))
  • Readiness to change(2 weeks within eligibility evaluation)
  • World Health Organization Well-Being Index (WHO-5)(2 weeks within eligibility evaluation)
  • Perceived Improvement Questionnaire(3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th))
  • Client Satisfaction Questionnaire (CSQ-3)(3 months after first interview for the arm ''immediate treatment'' and 6 months after first interview for the group ''waiting list'')
  • Scale to Assess the Therapeutic Relationship-Client (STAR-C)(3 months after first interview for the arm ''immediate treatment'' and 6 months after first interview for the group ''waiting list'')
  • Perception of reaching the goal(3 months after first interview for the arm ''immediate treatment'' and 6 months after first interview for the group ''waiting list'')
  • Impulsivity assessment with the Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale, short version (UPPS-P short)(2 weeks within eligibility evaluation)
  • Work and social adjustment scale (WSAS)(2 weeks within eligibility evaluation)
  • Motivations to change(2 weeks within eligibility evaluation)
  • Attention disorder and hyperactivity disorder (ADHD) assesment(2 weeks within eligibility evaluation)
  • Difficulties associated with the alcohol-use(2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th))
  • Perception of actual alcohol use(2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th))
  • Satisfaction with Life Domains Scale(2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th))
  • Generalized Anxiety Disorder (GAD-7)(2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th))
  • Patient Health Questionnaire (PHQ-9)(2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th))
  • Importance of change(2 weeks within eligibility evaluation)
  • Confidence to reach the alcohol use goal(2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th))
  • High-risk situations of alcohol use assessment(2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joël Tremblay

Professor

Université du Québec à Trois-Rivières

研究点 (10)

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