Clinical trial NCT05358613: My Choices: Efficacy and Implementation Study
Official title: Early Intervention Programs for at Risk Use of Psychoactive Substances and Gambling: ''My Choices'' Family
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder, Mild
Alcohol Use, Unspecified
Keywords: Alcohol
Treatment
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either receive the treatment now (10 working days, experimental group) or in 3 months (control group).
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in self-reports of alcohol with the time-line follow-back (TLFB) in the last 90 days
timeFrame: 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)
measure: Change in the Short Alcohol Dependance Data Questionnaire (SADD)
timeFrame: 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)
measure: Change in the Inventory of consequences associated with alcohol use
timeFrame: 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)
measure: Change in the Severity of dependence scale (SDS)
timeFrame: 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)
Secondary outcomes:
measure: Satisfaction with Life Domains Scale
timeFrame: 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)
measure: Medical Outcomes Study-Social Support Survey (MOS-SSS)
timeFrame: 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)
measure: Readiness to change
timeFrame: 2 weeks within eligibility evaluation
measure: Motivations to change
timeFrame: 2 weeks within eligibility evaluation
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 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)
measure: World Health Organization Well-Being Index (WHO-5)
timeFrame: 2 weeks within eligibility evaluation
measure: Impulsivity assessment with the Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale, short version (UPPS-P short)
timeFrame: 2 weeks within eligibility evaluation
measure: Attention disorder and hyperactivity disorder (ADHD) assesment
timeFrame: 2 weeks within eligibility evaluation
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 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)
measure: Work and social adjustment scale (WSAS)
timeFrame: 2 weeks within eligibility evaluation
measure: Perceived Improvement Questionnaire
timeFrame: 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)
measure: Client Satisfaction Questionnaire (CSQ-3)
timeFrame: 3 months after first interview for the arm ''immediate treatment'' and 6 months after first interview for the group ''waiting list''
measure: Scale to Assess the Therapeutic Relationship-Client (STAR-C)
timeFrame: 3 months after first interview for the arm ''immediate treatment'' and 6 months after first interview for the group ''waiting list''
measure: Perception of reaching the goal
timeFrame: 3 months after first interview for the arm ''immediate treatment'' and 6 months after first interview for the group ''waiting list''
measure: Difficulties associated with the alcohol-use
timeFrame: 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)
measure: Importance of change
timeFrame: 2 weeks within eligibility evaluation
measure: Perception of actual alcohol use
timeFrame: 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)
measure: Confidence to reach the alcohol use goal
timeFrame: 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)
measure: High-risk situations of alcohol use assessment
timeFrame: 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)
Other outcomes:
Locations:
city: Jonquière
country: Canada
facility: Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean
state: Quebec
city: Laval
country: Canada
facility: Centre Intégré de Santé Services Sociaux de Laval
state: Quebec
city: Lévis
country: Canada
facility: Centre intégré de Santé et de Services Sociaux de Chaudière-Appalaches
state: Quebec
city: Québec
country: Canada
facility: Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale
city: Québec
country: Canada
facility: Université du Québec à Trois-Rivières
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Joël Tremblay, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: