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

• Sponsor: Universidad Miguel Hernandez de Elche (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05281172
• Collaborator: Spanish Ministry of Science, Innovation, and Universities (Other)
• Enrollment: 800
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.1
• Patients Per Site Per Month: 34.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Abuse or Dependence	Behavioral: Guided Self-Change therapy (GSC); Behavioral: Psychoeducation program about healthy habits	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prevention of Alcohol Abuse in Educational Settings (PRVENALC)
• Actual Study Start Date: Mar 21, 2022
• Anticipated Primary Completion Date: Feb 22, 2024
• Anticipated Study Completion Date: Feb 22, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guided Self-Change therapy	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.
Active Comparator: Psychoeducation program about healthy habits	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Alcohol use change [Change from baseline up to 5 weeks and two follow-ups at 6 and 12 months post intervention]

   Alcohol use will be assessed using the Timeline Follow-Back (Sobell & Sobell, 1992)

2. Alcohol abuse [Change from baseline to week 5, and at 6 and 12 months post intervention.]

   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.

3. Alcohol dependence [Change from baseline to week 5, and at 6 and 12 months post intervention.]

   Alcohol dependence will be assessed with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (Grant et al., 2015).

Secondary Outcome Measures

1. Drug use [Change from baseline to week 5, and at 6 and 12 months post intervention.]

   Assessed with the Drug History Questionnaire (Sobell et al., 1995).

2. Impulsiveness [Change from baseline to week 5, and at 6 and 12 months post intervention.]

   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.

3. Sleep quality [Change from baseline to week 5, and at 6 and 12 months post intervention.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	José Luis Carballo	Elche	Alicante	Spain	03203

Sponsors and Collaborators

• Universidad Miguel Hernandez de Elche
• Spanish Ministry of Science, Innovation, and Universities

Investigators

• Principal Investigator: José Luis Carballo, PhD, Miguel Hernández University of Elche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jose Luis Carballo Crespo, PhD, Associate Professor and Researcher, Universidad Miguel Hernandez de Elche
• ClinicalTrials.gov Identifier: NCT05281172
• Other Study ID Numbers: PID2019-110400RB-I00
• First Posted: Mar 16, 2022
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcoholism

Study Results

No Results Posted as of May 18, 2022