Cognitive Behavioral Therapy Clinical Trial
Official title:
Design, Implementation and Evaluation of a Peer-led Alcohol Prevention Intervention for College Students. A Exploratory Trial
Verified date | June 2022 |
Source | Clinica Universidad de Navarra, Universidad de Navarra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A pilot randomized controlled trial was carried out. Fifty nursing students were randomly assigned either a 50-minute brief motivational intervention with individual feedback or a treatment-as-usual control condition. The intervention was delivered by undergraduate peer counsellors trained in Brief Alcohol Screening and Intervention for College Students. Primary outcomes for testing efficacy were alcohol use and alcohol-related consequences.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 31, 2021 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 20 Years |
Eligibility | Inclusion Criteria: - First year university students of Nursing Degree, between 18 and 20 years old. - Students of first access to the University. - Having had at least one episode of heavy drinking or binge drinking in the past month. Exclusion Criteria: - Students who have started or previously studied other university degrees or a higher degree. - University students who do not consume alcohol or, if they do consume alcohol, have not had binge drinking in the last month. |
Country | Name | City | State |
---|---|---|---|
Spain | University of Navarra | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
Clinica Universidad de Navarra, Universidad de Navarra |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in 'Quantitaty of alcohol use in a typical weekend' (preliminary efficacy outcomes) | Assesing the change in the total number of drinks during a typical weekend (Thursday, Friday, Saturday and Sunday) during the previous 30 days. | For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme) | |
Primary | Change in 'Estimated peak blood alcohol content (peak BAC)' (preliminary efficacy outcomes) | Assesing the change in the estimated peak blood alcohol content. It was calculated using participants' responses about maximum drinks consumed on the occasion of highest consumption in the last month, and the number of hours they spent drinking on that occasion. | For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme) | |
Primary | Change in 'Frequency of binge drinking episodes' (preliminary efficacy outcomes) | Assesing the change in the frequency of binge drinking episodes in the past month (5 or more (male)/ 4 or more (female) glasses of alcoholic beverages on the same drinking occasion). | For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme) | |
Primary | Change in 'Number of alcohol-related consequences (preliminary efficacy outcomes)' | Assesing the change in the number of negative consequences associated with their alcohol consumption in the previous 30 days. | For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme) | |
Secondary | Peer counselors' fidelity -adherence to motivational interviewing skills and alcohol-related content (feasibility outcomes) | Peer counselors' fidelity to the implementation of the intervention, including adherence to the theoretical alchol-related content, and the use of MI skills during the intervention.
For their measurement, an alcohol-related content checklist and the Peer Proficiency Assessment were used. |
From the beginning of the intervention sessions until the end of the intervention, an average of 3 months. | |
Secondary | Barriers and facilitators of the implementation process (feasibility outcomes) | Factors that have affected positively and negatively during the program implementation. | From the beginning of the peer counsellors' training until the end of the intervention, an average of 9 months. | |
Secondary | Acceptability -satisfaction- (feasibility outcomes) | Satisfaction of both participants and peer counsellors with the program. It was used and ad-hoc questionnaire | From the beginning of the intervention sessions until the end of the intervention, an average of 3 months. |
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