Guided Self-Change Prevention Program for Alcohol Abuse in Adolescents in Educational Settings (PREVENALC)
Primary Purpose
Alcohol Abuse or Dependence
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Guided Self-Change therapy (GSC)
Psychoeducation program about healthy habits
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Abuse or Dependence
Eligibility Criteria
Inclusion Criteria:
- 16-18 years old.
- Having inform consent from parents
- Report using alcohol at least once a month during the previous last three months
Exclusion Criteria:
- Participants will be excluded if they refer being diagnosed with a severe mental disorder.
- Have a severe medical illness that will limit participation
- Being under treatment for a psychological of psychiatric problem.
- Meet DSM criteria for Drug dependence to illegal drugs.
Sites / Locations
- José Luis CarballoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Guided Self-Change therapy
Psychoeducation program about healthy habits
Arm Description
Outcomes
Primary Outcome Measures
Alcohol use change
Alcohol use will be assessed using the Timeline Follow-Back (Sobell & Sobell, 1992)
Alcohol abuse
Alcohol abuse will be assessed using the Rutgers Alcohol Problem Index (White & Labouvie, 1989). The global score ranges from 0 to 69, where higher scores represent greater level of alcohol-related problems.
Alcohol dependence
Alcohol dependence will be assessed with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (Grant et al., 2015).
Secondary Outcome Measures
Drug use
Assessed with the Drug History Questionnaire (Sobell et al., 1995).
Impulsiveness
Impulsiveness will be assessed with the Impulsive Behavior Scale (Cyders et al., 2014). The global score ranges from 20 to 80, where higher scores represent greater level of impulsivity.
Sleep quality
Sleep will be assessed with different sleep measures, such as the Brief version of the Pittsburgh Sleep Quality Index (Sancho-Domingo et al., 2021). The global score of the B-PSQI ranges from 0 to 15, where higher scores represent poor sleep quality.
Full Information
NCT ID
NCT05281172
First Posted
February 10, 2022
Last Updated
May 16, 2022
Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Spanish Ministry of Science, Innovation, and Universities
1. Study Identification
Unique Protocol Identification Number
NCT05281172
Brief Title
Guided Self-Change Prevention Program for Alcohol Abuse in Adolescents in Educational Settings
Acronym
PREVENALC
Official Title
Prevention of Alcohol Abuse in Educational Settings (PRVENALC)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
February 22, 2024 (Anticipated)
Study Completion Date
February 22, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Spanish Ministry of Science, Innovation, and Universities
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study corresponds to a pretest-posttest randomized experimental design with two arms. Arm 1 includes Guided Self-Change program, and Arm 2 a psychoeducational program to promote healthy habits. This study aims to analyze the efficacy of a selective and indicated prevention program based on the Guided Self-Change model (GSC) in adolescent alcohol users between 16-18 years. Researchers hypothesize that implementation of GSC therapy will lead to a greater reduction of alcohol drinkers compare with the control condition, and will prevent alcohol abuse after 6 and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse or Dependence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guided Self-Change therapy
Arm Type
Experimental
Arm Title
Psychoeducation program about healthy habits
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Guided Self-Change therapy (GSC)
Intervention Description
The GSC program follows a motivational cognitive-behavioral approach designed to minimize resistance in drug behavior changes, prevent relapse risk, and increase motivation to quit. The GSC consists of 5 weekly sessions of 50 minutes delivered in groups of 20-25 people.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation program about healthy habits
Intervention Description
The psychoeducational program will include talks about healthy habits such as physical activity, relaxation, and sleep hygiene. This intervention consists of 5 weekly sessions of 50 minutes delivered in groups of 20-25 people.
Primary Outcome Measure Information:
Title
Alcohol use change
Description
Alcohol use will be assessed using the Timeline Follow-Back (Sobell & Sobell, 1992)
Time Frame
Change from baseline up to 5 weeks and two follow-ups at 6 and 12 months post intervention
Title
Alcohol abuse
Description
Alcohol abuse will be assessed using the Rutgers Alcohol Problem Index (White & Labouvie, 1989). The global score ranges from 0 to 69, where higher scores represent greater level of alcohol-related problems.
Time Frame
Change from baseline to week 5, and at 6 and 12 months post intervention.
Title
Alcohol dependence
Description
Alcohol dependence will be assessed with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (Grant et al., 2015).
Time Frame
Change from baseline to week 5, and at 6 and 12 months post intervention.
Secondary Outcome Measure Information:
Title
Drug use
Description
Assessed with the Drug History Questionnaire (Sobell et al., 1995).
Time Frame
Change from baseline to week 5, and at 6 and 12 months post intervention.
Title
Impulsiveness
Description
Impulsiveness will be assessed with the Impulsive Behavior Scale (Cyders et al., 2014). The global score ranges from 20 to 80, where higher scores represent greater level of impulsivity.
Time Frame
Change from baseline to week 5, and at 6 and 12 months post intervention.
Title
Sleep quality
Description
Sleep will be assessed with different sleep measures, such as the Brief version of the Pittsburgh Sleep Quality Index (Sancho-Domingo et al., 2021). The global score of the B-PSQI ranges from 0 to 15, where higher scores represent poor sleep quality.
Time Frame
Change from baseline to week 5, and at 6 and 12 months post intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
16-18 years old.
Having inform consent from parents
Report using alcohol at least once a month during the previous last three months
Exclusion Criteria:
Participants will be excluded if they refer being diagnosed with a severe mental disorder.
Have a severe medical illness that will limit participation
Being under treatment for a psychological of psychiatric problem.
Meet DSM criteria for Drug dependence to illegal drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Luis Carballo, PhD
Phone
(+34) 966658309
Email
jcarballo@umh.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Luis Carballo, PhD
Organizational Affiliation
Miguel Hernández University of Elche
Official's Role
Principal Investigator
Facility Information:
Facility Name
José Luis Carballo
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Luis, PhD
Phone
(+34) 966658309
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Guided Self-Change Prevention Program for Alcohol Abuse in Adolescents in Educational Settings
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