Guided Self-Change Prevention Program for Alcohol Abuse in Adolescents in Educational Settings

Alcohol Abuse or Dependence Clinical Trial

— PREVENALC  

Official title:

Prevention of Alcohol Abuse in Educational Settings (PRVENALC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05281172
• Other study ID #: PID2019-110400RB-I00
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Abuse or Dependence
• Alcoholism

Intervention

Behavioral:
• Guided Self-Change therapy (GSC)
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.
• Psychoeducation program about healthy habits
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.

Locations

Country	Name	City	State
Spain	José Luis Carballo	Elche	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Spanish Ministry of Science, Innovation, and Universities

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol use change	Alcohol use will be assessed using the Timeline Follow-Back (Sobell & Sobell, 1992)	Change from baseline up to 5 weeks and two follow-ups at 6 and 12 months post intervention
Primary	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.	Change from baseline to week 5, and at 6 and 12 months post intervention.
Primary	Alcohol dependence	Alcohol dependence will be assessed with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (Grant et al., 2015).	Change from baseline to week 5, and at 6 and 12 months post intervention.
Secondary	Drug use	Assessed with the Drug History Questionnaire (Sobell et al., 1995).	Change from baseline to week 5, and at 6 and 12 months post intervention.
Secondary	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.	Change from baseline to week 5, and at 6 and 12 months post intervention.
Secondary	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.	Change from baseline to week 5, and at 6 and 12 months post intervention.