Alcohol Abuse or DependencePREVENALCNCT05281172
Guided Self-Change Prevention Program for Alcohol Abuse in Adolescents in Educational Settings
A study testing Guided Self-Change therapy (GSC) and Psychoeducation program about healthy habits in people with Alcohol Abuse or Dependence, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse or Dependence
- What is being tested?
- Guided Self-Change therapy (GSC) and Psychoeducation program about healthy habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSpain
- Study dates
- 21 Mar 2022to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 16-18 years old.
- Having inform consent from parents
- Report using alcohol at least once a month during the previous last three months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Alcohol Abuse in Educational Settings (PRVENALC)
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.
- Conditions
- Alcohol Abuse or Dependence
- Being tested
- Guided Self-Change therapy (GSC), Psychoeducation program about healthy habits
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self-Change therapy (GSC)Behavioural
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 habitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided Self-Change therapy | Experimental | Not described Receives: Behavioral: Guided Self-Change therapy (GSC) |
| Psychoeducation program about healthy habits | Active comparator | Not described Receives: Behavioral: Psychoeducation program about healthy habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use change
Alcohol use will be assessed using the Timeline Follow-Back (Sobell \& Sobell, 1992)
Measured: Change from baseline up to 5 weeks and two follow-ups at 6 and 12 months post intervention
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.
Measured: Change from baseline to week 5, and at 6 and 12 months post intervention.
Alcohol dependence
Alcohol dependence will be assessed with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (Grant et al., 2015).
Measured: Change from baseline to week 5, and at 6 and 12 months post intervention.
Secondary outcomes (3)
Drug use
Assessed with the Drug History Questionnaire (Sobell et al., 1995).
Measured: Change from baseline to week 5, and at 6 and 12 months post intervention.
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.
Measured: Change from baseline to week 5, and at 6 and 12 months post intervention.
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.
Measured: Change from baseline to week 5, and at 6 and 12 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start21 Mar 2022
- Primary completion1 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Abuse or DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Principal investigator, Jose Luis Carballo Crespo, PhD, Universidad Miguel Hernandez de Elche
- Investigators
- José Luis Carballo, PhD, Principal investigator, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281172
- Sponsor's protocol ID
- PID2019-110400RB-I00
- Acronym
- PREVENALC
- Status last verified
- Jul 2024
- First submitted
- 10 Feb 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Alcohol Abuse in Educational Settings (PRVENALC)
- ClinicalTrials.gov ID
- NCT05281172
- Acronym / sponsor ID
- PREVENALC / PID2019-110400RB-I00
- Conditions
- Alcohol Abuse or Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Self-Change therapy | Experimental | Behavioral: Guided Self-Change therapy (GSC) |
| Psychoeducation program about healthy habits | Active comparator | Behavioral: Psychoeducation program about healthy habits |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 16-18 years old.
- Having inform consent from parents
- Report using alcohol at least once a month during the previous last three months
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Guided Self-Change therapy |
| Psychoeducation program about healthy habitsThe 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. | Behavioural | Psychoeducation program about healthy habits |
Primary outcome
Alcohol use change
Time frame: 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)
Alcohol abuse
Time frame: 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.
Alcohol dependence
Time frame: 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).
3 secondary outcomes
Drug use
Time frame: Change from baseline to week 5, and at 6 and 12 months post intervention.
Impulsiveness
Time frame: Change from baseline to week 5, and at 6 and 12 months post intervention.
Sleep quality
Time frame: Change from baseline to week 5, and at 6 and 12 months post intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Luis Carballo, PhD principal investigator
Universidad Miguel Hernandez de Elche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self-Change therapy (GSC) and Psychoeducation program about healthy habits in people with Alcohol Abuse or Dependence, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use change (time frame: Change from baseline up to 5 weeks and two follow-ups at 6 and 12 months post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.