Alcohol; Harmful UseNCT05533554
Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students
A study testing Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students in people with Alcohol; Harmful Use, run by Daniela Romero Reyes at 1 site in Mexico.
Trial summary
Brief behavioral intervention designed from the guidelines of the Theory of Planned Action (TAP) of Ajzen (1991). It has the general objective of reducing the intention and hazardous and harmful consumption of alcohol in young university students in the first year of their undergraduate degree. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol; Harmful Use
- What is being tested?
- Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteMexico
- Study dates
- 23 Sep 2022to 15 Jul 2023
- 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 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a university student in the first or second year.
- Be between 18 and 29 years old.
- Voluntarily participate in the study.
Who cannot join
- Presence of severe mental disorder (e.g., psychotic disorders).
- Not having stable housing.
Trial locations and contacts
1 site in 1 country.
About this study
Brief behavioral intervention designed from the guidelines of the Theory of Planned Action (TAP) of Ajzen (1991). It has the general objective of reducing the intention and hazardous and harmful consumption of alcohol in young university students in the first year of their undergraduate degree. The following specific objectives are considered: (a) Impact on the personal and descriptive norm by modifying the perception of the actual use of alcohol and its level of acceptance among the population of university students. (b) Modify attitudes towards consumption by reducing the value attributed to the expectations associated with risky alcohol consumption. (c) Increase perceived behavioral control and self-efficacy to avoid alcohol consumption behavior by: establishing a goal, consumption planning, and increase assertive communication.(d) Reduce the negative consequences of the use of alcohol in different situations of young people through pleasant healthy activities. e) Increase the intention to seek help for alcohol-related problems.The intervention will be developed through 3 phases. The first phase corresponds to the pre-intervention evaluation, the second phase concerns the two intervention sessions and the third phase is the post-intervention evaluation. Hypothesis: The mean alcohol consumption will be lower in young adults with hazardous and harmful alcohol consumption in the experimental group who received a brief online intervention compared to the control group.
Read the detailed description
The hazardous and harmful consumption of alcohol in university students is a public health problem, as shown by various international studies. The consequences of consumption, the harmful effects of alcohol, impact various areas of the lives of young adults and those close to them, among which can be mentioned the increased risk of physical harm, legal problems, breach of school, relational responsibilities, negative social interactions, and processing can also be affected cognitive.
The WHO's report of Independent High-Level Commission on Noncommunicable Diseases states that national governments and cities should participate in measures related to noncommunicable diseases, including discouraging the harmful use of alcohol and promote mental health. The global strategy to reduce the harmful use of alcohol includes support for screening and preventive interventions related to hazardous alcohol use in primary health care and other settings. In Mexico, the General Health Law in its article 185, establishes the program for the prevention, reduction, and treatment of the harmful use of alcohol, attention to alcoholism, the prevention of diseases derived from it. Among its actions is the promotion of prevention, early detection, guidance, care, referral and treatment services for people and groups with harmful use of alcohol, avoiding all forms of stigmatization. The Official Mexican Standard 028 for the prevention, treatment, and control of addictions, refers to prevention as those actions aimed at reducing the non-therapeutic consumption of psychoactive substances and indicates that preventive programs must have a theoretical and methodological framework; include vulnerable populations, considering mainly the youth population.
From the international and national scene, the need to preventively attend to the harmful consumption of alcohol is evident, emphasizing the youth population. As measures in such circumstances, online interventions have been effective in reducing risky alcohol consumption, the Anglo-Saxon scientific literature supports the use of the Internet to carry out interventions aimed at reducing alcohol consumption in university students. In Latin America, a first systematic review on brief interventions reported that the interventions studied were given in a traditional face-to-face format, most of them in Brazil and Mexico, with heterogeneous theoretical and methodological approaches used, however, using the internet as a means to carry out brief interventions can be beneficial for university students who are in regions where there is little information on alcohol consumption or for students who have difficulties participating in face-to-face strategies, the brief interventions can serve as health literacy tools mental health that encourage young people to seek early help.
There is increasing evidence that public health interventions based on theories of social and behavioral sciences are more effective than those that do not have such a theoretical basis, the theory is a fundamental element of behavioral interventions, theories explain the pathways that lead or predict behavior and thus provide guidance on how to influence or modify said behavior.
The Theory of Planned Action is a strong theoretical basis for developing interventions to make changes in health-related behaviors. According to TAP, behavior is preceded by intentions, which in turn are shaped by attitudes, subjective norm, and perceived behavioral control. Attitudes are made up of behavioral beliefs (beliefs about the results of behavior and the evaluation of these results), the subjective norm is made up of normative beliefs, that is, beliefs about the normative expectations of others and the motivation to comply with them. these expectations, perceived behavioral control is integrated from control beliefs (beliefs about the presence of factors that can facilitate or hinder behavior), the perceived behavioral control construct is compatible with Bandura's perceived self-efficacy , which refers to the perception of confidence in being able to carry out a behavior, beliefs of self-efficacy or perceived behavioral control are located by TAP in a framework of relationships between attitudes, beliefs, intentions and behavior.
Study Design:
An experimental methodology is contemplated with an experimental group and a control group on a waiting list, with pre and post evaluation.
Population, sampling and sample:
The population will be made up of university students. The participants will be first-year university students. Through the G Power program, it is considered that for an effect size of .80, with a significance level of 0.05 and .80 power, each group (control and experimental) should be made up of 26 participants, 52 participants in total.
Procedure for data collection:
Quality assurance plan. In accordance with the Good Clinical Practices: Document of the Americas, procedures were developed for each of the four phases of the study
- Conditions
- Alcohol; Harmful Use
- Being tested
- Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students
- Keywords
- Brief online intervention, Planned Behavior Theory, Hazardous and harmful use of alcohol, University Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University StudentsBehavioural
Cognitive-behavioral intervention where the key concepts of the Theory of Planned Behavior were operationalized from which two intervention sessions were formed and the most appropriate techniques were chosen to influence the key concepts of the theory: behavioral beliefs, subjective norms, perceived behavioral control and self-efficacy. The program is made up of 3 evaluation sessions (pre and post a month later) and 2 intervention sessions with a duration of 120 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group with intervention | Experimental | The experimental group will receive the intervention. First, the group will undergo a pre-intervention evaluation lasting 120 minutes. The intervention will consist of two synchronized virtual sessions of brief intervention with a cognitive-behavioral approach where various persuasive communication strategies will be implemented, definition of hazardous alcohol consumption, establishment of a consumption goal, social skills to deal with pressure to consume and plan of pleasant activities alternative to consumption, each session will last 120 minutes. Four weeks after the end of the intervention, the experimental group will carry out the post-intervention evaluation session in a virtual synchronized manner with a duration of 120 minutes. Receives: Behavioral: Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students |
| Control group | No intervention | The control group will participate in a pre-intervention evaluation session. Four weeks after the end of the last intra-session evaluation session, the control group will participate in the post-intervention evaluation in a virtual synchronized manner with a duration of 120 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in score on the Alcohol Use Disorders Identification Questionnaire - Concise (AUDIT-C)
The AUDIT-C has 3 questions and is scored on a scale of 0 to 12. Each AUDIT-C question has 5 response options valued from 0 points to 4 points. Lower scores indicate a positive response to the intervention. The instrument will be applied in the preevaluation and up to four weeks after the end of the intervention.
Measured: 4 weeks
Mean change in the amount of standard drinks ingested evaluated with the LIBARE Retrospective Baseline, from the initial evaluation, in two intra-sessions and two weeks after the end of the intervention
Instrument in the form of a calendar where the participant will be asked to record the days of consumption and the amount consumed according to the standard drink measure in a period of three months prior to the intervention. Afterwards, four weeks post-intervention, the participant will be asked to fill out this calendar for the 30 days that have elapsed since the last session. Fewer days of consumption, less number of drinks per consumption occasion and number of standard drinks ingested indicate a positive response to the intervention.
Measured: 4 weeks
Secondary outcomes (7)
Mean change in the assessment of the consequences of consumption (behavioral beliefs: attitude) measured through the TAP Questionnaire for alcohol consumption
Subscale made up of 25 items that evaluate attitude through consequences of consumption highly valued in the study population (behavioral beliefs), with 5 response options scored from 0 to 4 from "not important at all" to "very important". Lower scores indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it.
Measured: 4 weeks
Mean change in subjective, personal and descriptive norms measured through the TAP Questionnaire for alcohol consumption
Subscale composed of 2 items of subjective norms and 1 item of descriptive norms, with 5 Likert-type response options scored from 0 to 4, lower scores indicate a positive response to the intervention. It also includes 1 personal norm item with 5 response options scored from 0 to 4; higher scores on this item indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it.
Measured: 4 weeks
Mean change in perceived behavioral control measured through the TAP Questionnaire for alcohol consumption
Subscale composed of 2 items of perceived behavioral control towards alcohol consumption, scored from 0 to 4, lower scores on these items indicate a positive response to the intervention. The scale is also integrated by 3 items of perceived behavioral control towards alcohol abstinence, scored from 0 to 4, higher scores in these items indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it.
Measured: 4 weeks
Mean change in the intention to consume alcohol measured through the TAP Questionnaire for alcohol consumption
Scale composed of 3 items of alcohol consumption intention with five response options from 0 to 4. Lower scores indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it.
Measured: 4 weeks
Mean change in the degree of self-efficacy to face situations of alcohol consumption measured through the Brief Situational Confidence Questionnaire for university students
The objective of this scale is to measure the concept of self-efficacy in relation to the participant's perception of their ability to deal effectively with situations of alcohol consumption. The scale is made up of a single dimension of 4 items with response options from 0 (I do not trust myself) to 3 (I totally trust myself), the higher the score, the higher the self-efficacy. Higher scores on this scale indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it.
Measured: 4 weeks
Measurement of adverse events through the implementation of the Scale on Consequences of Alcohol Consumption in University Students
This instrument measures consequences of alcohol consumption. It has 25 items with "yes/no" response options for the occurrence of consequences and for the frequency of occurrence of consequences in the last month: 0 times, 1 time, 2 times, 3 times, 4 to 5 times, 6 to 7 times, 12 to 20 months, more than 21 times. Fewer number and frequency of consequences indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before the intervention and four weeks after it.
Measured: 4 weeks
Help-seeking intention in young adults with hazardous and harmful alcohol consumption questionnaire (IH-RHAC)
instrument aims to measure help-seeking intention and attitude, subjective norm, and perceived behavioral control (operationalized as self-efficacy) based on the beliefs underlying these constructs: behavioral beliefs, normative beliefs, respectively, including the variable seeking help in the past. The scale is composed of five sections: (a) attitude, (b) subjective norm, (c) self-efficacy, (d) help-seeking intentions, and (e) past help-seeking. Responses were scored on a Likert-type scale from 1 to 5. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start23 Sep 2022
- Primary completion30 Jun 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Alcohol; Harmful UseStudies 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
- Model description
- Experimental methodology with experimental group and control group on waiting list.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Romero Reyes
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional de Educación a Distancia
- Responsible party
- Sponsor-investigator, Daniela Romero Reyes, Universidad Autónoma de Tamaulipas
- Investigators
- Daniela Romero Reyes, Psychology, Principal investigator, Universidad Autónoma de TamaulipasJuan Antonio Moriano León, Psychology, Study director, Universidad Nacional de Educación a DistanciaJosé Luis Ybarra Sagarduy, Psychology, Study director, Universidad Autónoma de Tamaulipas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533554
- Sponsor's protocol ID
- 117
- Status last verified
- Aug 2023
- First submitted
- 5 Sep 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available to researchers who request it by email to danielaromeroreyes@gmail.com
Publications
Ajzen I. The theory of planned behavior. Organizational behavior and human decision processes. 1991;50(2):179-211.
Davoren MP, Demant J, Shiely F, Perry IJ. Alcohol consumption among university students in Ireland and the United Kingdom from 2002 to 2014: a systematic review. BMC Public Health. 2016 Feb 19;16:173. doi: 10.1186/s12889-016-2843-1.
PubMed 26895824Krieger H, Young CM, Anthenien AM, Neighbors C. The Epidemiology of Binge Drinking Among College-Age Individuals in the United States. Alcohol Res. 2018;39(1):23-30. doi: 10.35946/arcr.v39.1.05.
PubMed 30557145Yi S, Ngin C, Peltzer K, Pengpid S. Health and behavioral factors associated with binge drinking among university students in nine ASEAN countries. Subst Abuse Treat Prev Policy. 2017 Jun 26;12(1):32. doi: 10.1186/s13011-017-0117-2.
PubMed 28651601Bhochhibhoya A, Hayes L, Branscum P, Taylor L. The Use of the Internet for Prevention of Binge Drinking Among the College Population: A Systematic Review of Evidence. Alcohol Alcohol. 2015 Sep;50(5):526-35. doi: 10.1093/alcalc/agv047. Epub 2015 Jun 4.
PubMed 26047832Mota R, Fuentes-Mejía C, Belchior M, Pinto G, León F, Cruvinel E. Brief interventions for substance abuse in Latin America: a systematic review. Psychology in Study. 2019;(24).
Tebb KP, Erenrich RK, Jasik CB, Berna MS, Lester JC, Ozer EM. Use of theory in computer-based interventions to reduce alcohol use among adolescents and young adults: a systematic review. BMC Public Health. 2016 Jun 17;16:517. doi: 10.1186/s12889-016-3183-x.
PubMed 27317330Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399-418. doi: 10.1146/annurev.publhealth.012809.103604.
PubMed 20070207Norman P, Cameron D, Epton T, Webb TL, Harris PR, Millings A, Sheeran P. A randomized controlled trial of a brief online intervention to reduce alcohol consumption in new university students: Combining self-affirmation, theory of planned behaviour messages, and implementation intentions. Br J Health Psychol. 2018 Feb;23(1):108-127. doi: 10.1111/bjhp.12277. Epub 2017 Sep 20.
PubMed 28941040Ajzen I. Design and evaluation guided by the theory of planned behavior. Soc psychol Eval, Guilford Publications. 2011:74-100.
Hurlbut SC, Sher KJ. Assessing alcohol problems in college students. J Am Coll Health. 1992 Sep;41(2):49-58. doi: 10.1080/07448481.1992.10392818.
PubMed 1460173Salazar GM, Muro MD, Udave MA, Leos FM. Adaptation of the Young Adult Alcohol Problem Screening Test (YAAPST) with university students from Mexico. Research and science. 2012;20(56):44-52.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students
- ClinicalTrials.gov ID
- NCT05533554
- Acronym / sponsor ID
- 117
- Conditions
- Alcohol; Harmful Use
- Keywords
- Brief online intervention, Planned Behavior Theory, Hazardous and harmful use of alcohol, University Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Daniela Romero ReyesUniversity, hospital or other
- Collaborators
- Universidad Nacional de Educación a Distancia
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 9 Sep 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.
Brief behavioral intervention designed from the guidelines of the Theory of Planned Action (TAP) of Ajzen (1991). It has the general objective of reducing the intention and hazardous and harmful consumption of alcohol in young university students in the first year of their undergraduate degree. The following specific objectives are considered: (a) Impact on the personal and descriptive norm by modifying the perception of the actual use of alcohol and its level of acceptance among the population of university students. (b) Modify attitudes towards consumption by reducing the value attributed to the expectations associated with risky alcohol consumption. (c) Increase perceived behavioral control and self-efficacy to avoid alcohol consumption behavior by: establishing a goal, consumption planning, and increase assertive communication.(d) Reduce the negative consequences of the use of alcohol in different situations of young people through pleasant healthy activities. e) Increase the intention to seek help for alcohol-related problems.The intervention will be developed through 3 phases. The first phase corresponds to the pre-intervention evaluation, the second phase concerns the two intervention sessions and the third phase is the post-intervention evaluation. Hypothesis: The mean alcohol consumption will be lower in young adults with hazardous and harmful alcohol consumption in the experimental group who received a brief online intervention compared to the control group.
Detailed description
The hazardous and harmful consumption of alcohol in university students is a public health problem, as shown by various international studies. The consequences of consumption, the harmful effects of alcohol, impact various areas of the lives of young adults and those close to them, among which can be mentioned the increased risk of physical harm, legal problems, breach of school, relational responsibilities, negative social interactions, and processing can also be affected cognitive.
The WHO's report of Independent High-Level Commission on Noncommunicable Diseases states that national governments and cities should participate in measures related to noncommunicable diseases, including discouraging the harmful use of alcohol and promote mental health. The global strategy to reduce the harmful use of alcohol includes support for screening and preventive interventions related to hazardous alcohol use in primary health care and other settings. In Mexico, the General Health Law in its article 185, establishes the program for the prevention, reduction, and treatment of the harmful use of alcohol, attention to alcoholism, the prevention of diseases derived from it. Among its actions is the promotion of prevention, early detection, guidance, care, referral and treatment services for people and groups with harmful use of alcohol, avoiding all forms of stigmatization. The Official Mexican Standard 028 for the prevention, treatment, and control of addictions, refers to prevention as those actions aimed at reducing the non-therapeutic consumption of psychoactive substances and indicates that preventive programs must have a theoretical and methodological framework; include vulnerable populations, considering mainly the youth population.
From the international and national scene, the need to preventively attend to the harmful consumption of alcohol is evident, emphasizing the youth population. As measures in such circumstances, online interventions have been effective in reducing risky alcohol consumption, the Anglo-Saxon scientific literature supports the use of the Internet to carry out interventions aimed at reducing alcohol consumption in university students. In Latin America, a first systematic review on brief interventions reported that the interventions studied were given in a traditional face-to-face format, most of them in Brazil and Mexico, with heterogeneous theoretical and methodological approaches used, however, using the internet as a means to carry out brief interventions can be beneficial for university students who are in regions where there is little information on alcohol consumption or for students who have difficulties participating in face-to-face strategies, the brief interventions can serve as health literacy tools mental health that encourage young people to seek early help.
There is increasing evidence that public health interventions based on theories of social and behavioral sciences are more effective than those that do not have such a theoretical basis, the theory is a fundamental element of behavioral interventions, theories explain the pathways that lead or predict behavior and thus provide guidance on how to influence or modify said behavior.
The Theory of Planned Action is a strong theoretical basis for developing interventions to make changes in health-related behaviors. According to TAP, behavior is preceded by intentions, which in turn are shaped by attitudes, subjective norm, and perceived behavioral control. Attitudes are made up of behavioral beliefs (beliefs about the results of behavior and the evaluation of these results), the subjective norm is made up of normative beliefs, that is, beliefs about the normative expectations of others and the motivation to comply with them. these expectations, perceived behavioral control is integrated from control beliefs (beliefs about the presence of factors that can facilitate or hinder behavior), the perceived behavioral control construct is compatible with Bandura's perceived self-efficacy , which refers to the perception of confidence in being able to carry out a behavior, beliefs of self-efficacy or perceived behavioral control are located by TAP in a framework of relationships between attitudes, beliefs, intentions and behavior.
Study Design:
An experimental methodology is contemplated with an experimental group and a control group on a waiting list, with pre and post evaluation.
Population, sampling and sample:
The population will be made up of university students. The participants will be first-year university students. Through the G Power program, it is considered that for an effect size of .80, with a significance level of 0.05 and .80 power, each group (control and experimental) should be made up of 26 participants, 52 participants in total.
Procedure for data collection:
Quality assurance plan. In accordance with the Good Clinical Practices: Document of the Americas, procedures were developed for each of the four phases of the study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental methodology with experimental group and control group on waiting list.
| Arm | Type | Receives |
|---|---|---|
| Experimental group with intervention | Experimental | Behavioral: Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University StudentsThe experimental group will receive the intervention. First, the group will undergo a pre-intervention evaluation lasting 120 minutes. The intervention will consist of two synchronized virtual sessions of brief intervention with a cognitive-behavioral approach where various persuasive communication strategies will be implemented, definition of hazardous alcohol consumption, establishment of a consumption goal, social skills to deal with pressure to consume and plan of pleasant activities alternative to consumption, each session will last 120 minutes. Four weeks after the end of the intervention, the experimental group will carry out the post-intervention evaluation session in a virtual synchronized manner with a duration of 120 minutes. |
| Control group | No intervention | –The control group will participate in a pre-intervention evaluation session. Four weeks after the end of the last intra-session evaluation session, the control group will participate in the post-intervention evaluation in a virtual synchronized manner with a duration of 120 minutes. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be a university student in the first or second year.
- Be between 18 and 29 years old.
- Voluntarily participate in the study.
Key exclusion criteria (2 listed)
- Presence of severe mental disorder (e.g., psychotic disorders).
- Not having stable housing.
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 |
|---|---|---|
| Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University StudentsCognitive-behavioral intervention where the key concepts of the Theory of Planned Behavior were operationalized from which two intervention sessions were formed and the most appropriate techniques were chosen to influence the key concepts of the theory: behavioral beliefs, subjective norms, perceived behavioral control and self-efficacy. The program is made up of 3 evaluation sessions (pre and post a month later) and 2 intervention sessions with a duration of 120 minutes each. | Behavioural | Experimental group with intervention |
Primary outcome
Mean change in score on the Alcohol Use Disorders Identification Questionnaire - Concise (AUDIT-C)
Time frame: 4 weeks
The AUDIT-C has 3 questions and is scored on a scale of 0 to 12. Each AUDIT-C question has 5 response options valued from 0 points to 4 points. Lower scores indicate a positive response to the intervention. The instrument will be applied in the preevaluation and up to four weeks after the end of the intervention.
Mean change in the amount of standard drinks ingested evaluated with the LIBARE Retrospective Baseline, from the initial evaluation, in two intra-sessions and two weeks after the end of the intervention
Time frame: 4 weeks
Instrument in the form of a calendar where the participant will be asked to record the days of consumption and the amount consumed according to the standard drink measure in a period of three months prior to the intervention. Afterwards, four weeks post-intervention, the participant will be asked to fill out this calendar for the 30 days that have elapsed since the last session. Fewer days of consumption, less number of drinks per consumption occasion and number of standard drinks ingested indicate a positive response to the intervention.
7 secondary outcomes
Mean change in the assessment of the consequences of consumption (behavioral beliefs: attitude) measured through the TAP Questionnaire for alcohol consumption
Time frame: 4 weeks
Mean change in subjective, personal and descriptive norms measured through the TAP Questionnaire for alcohol consumption
Time frame: 4 weeks
Mean change in perceived behavioral control measured through the TAP Questionnaire for alcohol consumption
Time frame: 4 weeks
Mean change in the intention to consume alcohol measured through the TAP Questionnaire for alcohol consumption
Time frame: 4 weeks
Mean change in the degree of self-efficacy to face situations of alcohol consumption measured through the Brief Situational Confidence Questionnaire for university students
Time frame: 4 weeks
Measurement of adverse events through the implementation of the Scale on Consequences of Alcohol Consumption in University Students
Time frame: 4 weeks
Help-seeking intention in young adults with hazardous and harmful alcohol consumption questionnaire (IH-RHAC)
Time frame: 4 weeks
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 18 Aug 2023.
- BackgroundAjzen I. The theory of planned behavior. Organizational behavior and human decision processes. 1991;50(2):179-211.
- Background: PubMed 26895824Davoren MP, Demant J, Shiely F, Perry IJ. Alcohol consumption among university students in Ireland and the United Kingdom from 2002 to 2014: a systematic review. BMC Public Health. 2016 Feb 19;16:173. doi: 10.1186/s12889-016-2843-1.
- Background: PubMed 30557145Krieger H, Young CM, Anthenien AM, Neighbors C. The Epidemiology of Binge Drinking Among College-Age Individuals in the United States. Alcohol Res. 2018;39(1):23-30. doi: 10.35946/arcr.v39.1.05.
- Background: PubMed 28651601Yi S, Ngin C, Peltzer K, Pengpid S. Health and behavioral factors associated with binge drinking among university students in nine ASEAN countries. Subst Abuse Treat Prev Policy. 2017 Jun 26;12(1):32. doi: 10.1186/s13011-017-0117-2.
- Background: PubMed 26047832Bhochhibhoya A, Hayes L, Branscum P, Taylor L. The Use of the Internet for Prevention of Binge Drinking Among the College Population: A Systematic Review of Evidence. Alcohol Alcohol. 2015 Sep;50(5):526-35. doi: 10.1093/alcalc/agv047. Epub 2015 Jun 4.
- BackgroundMota R, Fuentes-Mejía C, Belchior M, Pinto G, León F, Cruvinel E. Brief interventions for substance abuse in Latin America: a systematic review. Psychology in Study. 2019;(24).
- Background: PubMed 27317330Tebb KP, Erenrich RK, Jasik CB, Berna MS, Lester JC, Ozer EM. Use of theory in computer-based interventions to reduce alcohol use among adolescents and young adults: a systematic review. BMC Public Health. 2016 Jun 17;16:517. doi: 10.1186/s12889-016-3183-x.
- Background: PubMed 20070207Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399-418. doi: 10.1146/annurev.publhealth.012809.103604.
- Background: PubMed 28941040Norman P, Cameron D, Epton T, Webb TL, Harris PR, Millings A, Sheeran P. A randomized controlled trial of a brief online intervention to reduce alcohol consumption in new university students: Combining self-affirmation, theory of planned behaviour messages, and implementation intentions. Br J Health Psychol. 2018 Feb;23(1):108-127. doi: 10.1111/bjhp.12277. Epub 2017 Sep 20.
- BackgroundAjzen I. Design and evaluation guided by the theory of planned behavior. Soc psychol Eval, Guilford Publications. 2011:74-100.
- Background: PubMed 1460173Hurlbut SC, Sher KJ. Assessing alcohol problems in college students. J Am Coll Health. 1992 Sep;41(2):49-58. doi: 10.1080/07448481.1992.10392818.
- BackgroundSalazar GM, Muro MD, Udave MA, Leos FM. Adaptation of the Young Adult Alcohol Problem Screening Test (YAAPST) with university students from Mexico. Research and science. 2012;20(56):44-52.
- World Health Organization. (2018) Report of the WHO Independent High-Level Commission on Noncommunicable Diseases. Geneva, Switzerland.Link provided by the sponsor.
- Chamber of Deputies of the H. Congress of the Union. (2022, May 16) General Health Law. Official Journal of the Federation.Link provided by the sponsor.
- World Health Organization (2005). Document of the Americas on Good Clinical Practices. Pan American Health Organization.Link provided by the sponsor.
- World Medical Association (2013). Declaration of Helsinki.Link provided by the sponsor.
- World Health Organization. (2010) Global strategy to reduce the harmful use of alcohol. Geneva, SwitzerlandLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data will be available to researchers who request it by email to danielaromeroreyes@gmail.com
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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.
Daniela Romero Reyes, Psychology principal investigator
Universidad Autónoma de Tamaulipas
Juan Antonio Moriano León, Psychology study director
Universidad Nacional de Educación a Distancia
José Luis Ybarra Sagarduy, Psychology study director
Universidad Autónoma de Tamaulipas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students in people with Alcohol; Harmful Use, run by Daniela Romero Reyes at 1 site in Mexico.
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 2 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 18 Aug 2023. 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 Mexico. 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?
Mean change in score on the Alcohol Use Disorders Identification Questionnaire - Concise (AUDIT-C) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05533554, which also lists 12 linked publications.
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 18 Aug 2023.