Substance UseYSLQQ-PilotNCT04566627
Acceptability and Feasibility Study of the Program "Yo Se Lo Que Quiero" (Unplugged)
A study testing "Yo Sé Lo Que Quiero" programl in people with Substance Use and Adolescent Behavior, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
Substance use and drug related disorders are important public health problems. Alcohol and illicit drug use account for 5.4% of the total burden of disease and the peak has been found in early adulthood (between ages 20 and 30 years). Substance use is one of the leading problems among Chilean adolescents. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Adolescent Behavior
- What is being tested?
- "Yo Sé Lo Que Quiero" programl
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,214 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2019to 30 Dec 2019
- 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 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mixed schools (boys and girls)
- Schools with a high vulnerability index, IVESINAE > 70%. The IVESINAE is an indicator of the proportion of the students who have several risk factors regarding family income, parental education among other factors. This index is built by the Ministry of Education in Chile and help to direct resources to the schools.
- Located in the Metropolitan region in Chile.
Who cannot join
- Having a structure and manualized substance use preventive program in place.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Feasibility Study of the Program "Yo Se Lo Que Quiero" (Unplugged) Aiming to Reduce Substance Use Among Adolescents in Chile: a Pilot Randomized Controlled Study.
Substance use and drug related disorders are important public health problems. Alcohol and illicit drug use account for 5.4% of the total burden of disease and the peak has been found in early adulthood (between ages 20 and 30 years). Substance use is one of the leading problems among Chilean adolescents. One out of four 8 th to 12 th graders have smoked cigarettes in the last month. A 35.6% of students (37%, girls; 34.2%, boys) between Year 8 and Year 12 have reported any alcohol use during the last month. It is worrying that a third of 14 years old students report using alcohol in the last month in Chile. Furthermore, two out of three who are using alcohol, report regularly using 5 or more drinks in a row during the last month. Cannabis use among young Chileans has increased in recent years. Today, one out of five students between Year 8 and Year 12 referred cannabis use during the last 30 days. Almost a 20% of students in Year 8 have used cannabis in the last year.
Therefore, is urgent to provide evidence-based drug preventive interventions to the Chilean population, specifically to school students, to tackle this problem and reduce the risk for a more dramatic future health scenario.
The aim of this study was to assess the acceptability and feasibility of the cultural adaptation of "Yo Sé Lo Que Quiero" program. This is a pilot randomized controlled trial. The participants of this pilot were students attending six low-income primary schools in Santiago, Chile.
Read the detailed description
Substance use and drug related disorders are important public health problems. Alcohol and illicit drug use account for 5.4% of the total burden of disease and the peak has been found in early adulthood (between ages 20 and 30 years). Substance use is one of the leading problems among Chilean adolescents. One out of four 8 th to 12 th graders have smoked cigarettes in the last month. A 35.6% of students (37%, girls; 34.2%, boys) between Year 8 and Year 12 have reported any alcohol use during the last month. It is worrying that a third of 14 years old students report using alcohol in the last month in Chile. Furthermore, two out of three who are using alcohol, report regularly using 5 or more drinks in a row during the last month. Cannabis use among young Chileans has increased in recent years. Today, one out of five students between Year 8 and Year 12 referred cannabis use during the last 30 days. Almost a 20% of students in Year 8 have used cannabis in the last year.
Therefore, is urgent to provide evidence-based drug preventive interventions to the Chilean population, specifically to school students, to tackle this problem and reduce the risk for a more dramatic future health scenario.
The aim of this study was to assess the acceptability and feasibility of the cultural adaptation of "Yo Sé Lo Que Quiero" program. This is a pilot randomized controlled trial. The participants of this pilot were students attending six low-income primary schools in Santiago, Chile.
This pilot study is part of a larger research project with the final aim of testing the effectiveness of "Yo Sé Lo Que Quiero" program to reduce substance use among adolescents in Chile.
- Conditions
- Substance Use, Adolescent Behavior
- Being tested
- "Yo Sé Lo Que Quiero" programl
- Medical subject headings
- Substance-Related Disorders, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Yo Sé Lo Que Quiero" programlBehavioural
Also called Unplugged, Todojunto
"Yo Sé Lo Que Quiero" program is the cultural adaptation of the Unplugged program. This is a preventive intervention to reduce tobacco, alcohol, and marihuana use among adolescents. It consists of 12 sessions, delivered by a trained facilitator on a weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| YSLQQ group | Experimental | Schools in this group implemented "Yo Sé Lo Que Quiero" program. This is the cultural adaptation of the Unplugged program. This is a preventive intervention to reduce tobacco, alcohol, and marihuana use among adolescents. It consists of 12 sessions, delivered by a trained facilitator on a weekly basis. Receives: Behavioral: "Yo Sé Lo Que Quiero" programl |
| Control Group | No intervention | Schools in this group implemented the usual preventive actions to reduce substance use. Usually, these actions are not manualized. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the program by students
A questionnaire exploring the acceptability of the program was answered by the students who participated in the intervention. This questionnaire asked about the students´opinions about the content of the intervention, strategies used, materials, and performance of the facilitators. The questionnaire also asked about satisfaction and the helpfulness of the program to improve emotions management, school climate, relationships with other people, and learning about drugs´ risks. Finally, the questionnaire asked about sense of self-efficacy to avoid drugs today and in the future.
Measured: Inmediately Post-intervention
Feasibility of the program
A register was used to determine the number of schools initially contacted and the number of schools that accepted to participate; number of students that consented and assented to participate in the study at baseline and at follow-up; the number of sessions planned and actually delivered; the number of schools and teachers that participated in the training.
Measured: 1 year
Secondary outcomes (2)
EU-Dap
The European Drug Addiction Prevention Trial Questionnaire (EU-Dap) was the instrument used to evaluate the Unplugged drug prevention program among adolescents in The European Drug Addiction Prevention (EU-Dap) trial project which took place between 2003-2005. EU-Dap was granted by the European Commission within the 2002 and 2005 Public Health Programme for drug prevention (Grant #SPC 2002376 and Grant #SPC 2005312).
This questionnaire collects information, knowledge and opinions on substance use, with emphasis on alcohol, tobacco and drugs use. It also gather information about tobacco, alcohol, marijuana and other drugs use; and assess risk and protective factors. It consists of 45 questions. In the Chilean validation, all subscales had an acceptable internal reliability (omega > 0.65).
Measured: One month
SURPS
The Substance Use Risk Profile Scale, is a self-reported questionnaire that gather information about anxiety sensitivity, hopelessness, sensation seeking, and impulsivity. These four sub scales have been associated as risk factors for drug use among adolescents. the internal reliability for each subscale is: anxiety sensitivity (alpha=0.65), hopelessness (alpha=0.76), sensation seeking (alpha=0.62), and impulsivity (alpha=0.61).
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Mar 2019
- Primary completion30 Nov 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Substance 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
- Participants are assigned to one of two groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Responsible party
- Principal investigator, Jorge Gaete, Universidad de los Andes, Chile
- Investigators
- Jorge Gaete, MD PhD, Principal investigator, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566627
- Sponsor's protocol ID
- Fondecyt Regular 1181724 Pilot
- Acronym
- YSLQQ-Pilot
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Faggiano F, Galanti MR, Bohrn K, Burkhart G, Vigna-Taglianti F, Cuomo L, Fabiani L, Panella M, Perez T, Siliquini R, van der Kreeft P, Vassara M, Wiborg G; EU-Dap Study Group. The effectiveness of a school-based substance abuse prevention program: EU-Dap cluster randomised controlled trial. Prev Med. 2008 Nov;47(5):537-43. doi: 10.1016/j.ypmed.2008.06.018. Epub 2008 Jul 9.
PubMed 18657569Faggiano F, Vigna-Taglianti F, Burkhart G, Bohrn K, Cuomo L, Gregori D, Panella M, Scatigna M, Siliquini R, Varona L, van der Kreeft P, Vassara M, Wiborg G, Galanti MR; EU-Dap Study Group. The effectiveness of a school-based substance abuse prevention program: 18-month follow-up of the EU-Dap cluster randomized controlled trial. Drug Alcohol Depend. 2010 Apr 1;108(1-2):56-64. doi: 10.1016/j.drugalcdep.2009.11.018. Epub 2010 Jan 18.
PubMed 20080363Vigna-Taglianti FD, Galanti MR, Burkhart G, Caria MP, Vadrucci S, Faggiano F; EU-Dap Study Group. "Unplugged," a European school-based program for substance use prevention among adolescents: overview of results from the EU-Dap trial. New Dir Youth Dev. 2014 Spring;2014(141):67-82, 11-2. doi: 10.1002/yd.20087.
PubMed 24753279Faggiano F, Richardson C, Bohrn K, Galanti MR; EU-Dap Study Group. A cluster randomized controlled trial of school-based prevention of tobacco, alcohol and drug use: the EU-Dap design and study population. Prev Med. 2007 Feb;44(2):170-3. doi: 10.1016/j.ypmed.2006.09.010. Epub 2006 Nov 3.
PubMed 17084887Prado MC, Schneider DR, Sanudo A, Pereira AP, Horr JF, Sanchez ZM. Transcultural Adaptation of Questionnaire to Evaluate Drug Use Among Students: The Use of the EU-Dap European Questionnaire in Brazil. Subst Use Misuse. 2016;51(4):449-58. doi: 10.3109/10826084.2015.1117108. Epub 2016 Feb 19.
PubMed 26894657Sanchez ZM, Valente JY, Sanudo A, Pereira APD, Cruz JI, Schneider D, Andreoni S. The #Tamojunto Drug Prevention Program in Brazilian Schools: a Randomized Controlled Trial. Prev Sci. 2017 Oct;18(7):772-782. doi: 10.1007/s11121-017-0770-8.
PubMed 28361199Newton NC, Barrett EL, Castellanos-Ryan N, Kelly E, Champion KE, Stapinski L, Conrod PJ, Slade T, Nair N, Teesson M. The validity of the Substance Use Risk Profile Scale (SURPS) among Australian adolescents. Addict Behav. 2016 Feb;53:23-30. doi: 10.1016/j.addbeh.2015.09.015. Epub 2015 Sep 25.
PubMed 26441044Woicik PA, Stewart SH, Pihl RO, Conrod PJ. The Substance Use Risk Profile Scale: a scale measuring traits linked to reinforcement-specific substance use profiles. Addict Behav. 2009 Dec;34(12):1042-55. doi: 10.1016/j.addbeh.2009.07.001. Epub 2009 Jul 8.
PubMed 19683400Salgado G, Gaete J, Gana S, Valenzuela D, Araya R. Acceptability, feasibility and fidelity of the culturally adapted version of Unplugged ("Yo Se Lo Que Quiero"), a substance use preventive program among adolescents in Chile: a pilot randomized controlled study. BMC Public Health. 2024 Jul 29;24(1):2026. doi: 10.1186/s12889-024-19499-2.
PubMed 39075465
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility Study of the Program "Yo Se Lo Que Quiero" (Unplugged) Aiming to Reduce Substance Use Among Adolescents in Chile: a Pilot Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04566627
- Acronym / sponsor ID
- YSLQQ-Pilot / Fondecyt Regular 1181724 Pilot
- Conditions
- Substance Use, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,214 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 28 Sep 2020 (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.
Substance use and drug related disorders are important public health problems. Alcohol and illicit drug use account for 5.4% of the total burden of disease and the peak has been found in early adulthood (between ages 20 and 30 years). Substance use is one of the leading problems among Chilean adolescents. One out of four 8 th to 12 th graders have smoked cigarettes in the last month. A 35.6% of students (37%, girls; 34.2%, boys) between Year 8 and Year 12 have reported any alcohol use during the last month. It is worrying that a third of 14 years old students report using alcohol in the last month in Chile. Furthermore, two out of three who are using alcohol, report regularly using 5 or more drinks in a row during the last month. Cannabis use among young Chileans has increased in recent years. Today, one out of five students between Year 8 and Year 12 referred cannabis use during the last 30 days. Almost a 20% of students in Year 8 have used cannabis in the last year.
Therefore, is urgent to provide evidence-based drug preventive interventions to the Chilean population, specifically to school students, to tackle this problem and reduce the risk for a more dramatic future health scenario.
The aim of this study was to assess the acceptability and feasibility of the cultural adaptation of "Yo Sé Lo Que Quiero" program. This is a pilot randomized controlled trial. The participants of this pilot were students attending six low-income primary schools in Santiago, Chile.
Detailed description
Substance use and drug related disorders are important public health problems. Alcohol and illicit drug use account for 5.4% of the total burden of disease and the peak has been found in early adulthood (between ages 20 and 30 years). Substance use is one of the leading problems among Chilean adolescents. One out of four 8 th to 12 th graders have smoked cigarettes in the last month. A 35.6% of students (37%, girls; 34.2%, boys) between Year 8 and Year 12 have reported any alcohol use during the last month. It is worrying that a third of 14 years old students report using alcohol in the last month in Chile. Furthermore, two out of three who are using alcohol, report regularly using 5 or more drinks in a row during the last month. Cannabis use among young Chileans has increased in recent years. Today, one out of five students between Year 8 and Year 12 referred cannabis use during the last 30 days. Almost a 20% of students in Year 8 have used cannabis in the last year.
Therefore, is urgent to provide evidence-based drug preventive interventions to the Chilean population, specifically to school students, to tackle this problem and reduce the risk for a more dramatic future health scenario.
The aim of this study was to assess the acceptability and feasibility of the cultural adaptation of "Yo Sé Lo Que Quiero" program. This is a pilot randomized controlled trial. The participants of this pilot were students attending six low-income primary schools in Santiago, Chile.
This pilot study is part of a larger research project with the final aim of testing the effectiveness of "Yo Sé Lo Que Quiero" program to reduce substance use among adolescents in Chile.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| YSLQQ group | Experimental | Behavioral: "Yo Sé Lo Que Quiero" programlSchools in this group implemented "Yo Sé Lo Que Quiero" program. This is the cultural adaptation of the Unplugged program. This is a preventive intervention to reduce tobacco, alcohol, and marihuana use among adolescents. It consists of 12 sessions, delivered by a trained facilitator on a weekly basis. |
| Control Group | No intervention | –Schools in this group implemented the usual preventive actions to reduce substance use. Usually, these actions are not manualized. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Mixed schools (boys and girls)
- Schools with a high vulnerability index, IVESINAE > 70%. The IVESINAE is an indicator of the proportion of the students who have several risk factors regarding family income, parental education among other factors. This index is built by the Ministry of Education in Chile and help to direct resources to the schools.
- Located in the Metropolitan region in Chile.
Key exclusion criteria (1 listed)
- Having a structure and manualized substance use preventive program in place.
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 |
|---|---|---|
| "Yo Sé Lo Que Quiero" programlAlso: Unplugged, Todojunto"Yo Sé Lo Que Quiero" program is the cultural adaptation of the Unplugged program. This is a preventive intervention to reduce tobacco, alcohol, and marihuana use among adolescents. It consists of 12 sessions, delivered by a trained facilitator on a weekly basis. | Behavioural | YSLQQ group |
Primary outcome
Acceptability of the program by students
Time frame: Inmediately Post-intervention
A questionnaire exploring the acceptability of the program was answered by the students who participated in the intervention. This questionnaire asked about the students´opinions about the content of the intervention, strategies used, materials, and performance of the facilitators. The questionnaire also asked about satisfaction and the helpfulness of the program to improve emotions management, school climate, relationships with other people, and learning about drugs´ risks. Finally, the questionnaire asked about sense of self-efficacy to avoid drugs today and in the future.
Feasibility of the program
Time frame: 1 year
A register was used to determine the number of schools initially contacted and the number of schools that accepted to participate; number of students that consented and assented to participate in the study at baseline and at follow-up; the number of sessions planned and actually delivered; the number of schools and teachers that participated in the training.
2 secondary outcomes
EU-Dap
Time frame: One month
SURPS
Time frame: One month
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 28 Sep 2020.
- Results publication: PubMed 18657569Faggiano F, Galanti MR, Bohrn K, Burkhart G, Vigna-Taglianti F, Cuomo L, Fabiani L, Panella M, Perez T, Siliquini R, van der Kreeft P, Vassara M, Wiborg G; EU-Dap Study Group. The effectiveness of a school-based substance abuse prevention program: EU-Dap cluster randomised controlled trial. Prev Med. 2008 Nov;47(5):537-43. doi: 10.1016/j.ypmed.2008.06.018. Epub 2008 Jul 9.
- Results publication: PubMed 20080363Faggiano F, Vigna-Taglianti F, Burkhart G, Bohrn K, Cuomo L, Gregori D, Panella M, Scatigna M, Siliquini R, Varona L, van der Kreeft P, Vassara M, Wiborg G, Galanti MR; EU-Dap Study Group. The effectiveness of a school-based substance abuse prevention program: 18-month follow-up of the EU-Dap cluster randomized controlled trial. Drug Alcohol Depend. 2010 Apr 1;108(1-2):56-64. doi: 10.1016/j.drugalcdep.2009.11.018. Epub 2010 Jan 18.
- Results publication: PubMed 24753279Vigna-Taglianti FD, Galanti MR, Burkhart G, Caria MP, Vadrucci S, Faggiano F; EU-Dap Study Group. "Unplugged," a European school-based program for substance use prevention among adolescents: overview of results from the EU-Dap trial. New Dir Youth Dev. 2014 Spring;2014(141):67-82, 11-2. doi: 10.1002/yd.20087.
- Results publication: PubMed 17084887Faggiano F, Richardson C, Bohrn K, Galanti MR; EU-Dap Study Group. A cluster randomized controlled trial of school-based prevention of tobacco, alcohol and drug use: the EU-Dap design and study population. Prev Med. 2007 Feb;44(2):170-3. doi: 10.1016/j.ypmed.2006.09.010. Epub 2006 Nov 3.
- Results publication: PubMed 26894657Prado MC, Schneider DR, Sanudo A, Pereira AP, Horr JF, Sanchez ZM. Transcultural Adaptation of Questionnaire to Evaluate Drug Use Among Students: The Use of the EU-Dap European Questionnaire in Brazil. Subst Use Misuse. 2016;51(4):449-58. doi: 10.3109/10826084.2015.1117108. Epub 2016 Feb 19.
- Results publication: PubMed 28361199Sanchez ZM, Valente JY, Sanudo A, Pereira APD, Cruz JI, Schneider D, Andreoni S. The #Tamojunto Drug Prevention Program in Brazilian Schools: a Randomized Controlled Trial. Prev Sci. 2017 Oct;18(7):772-782. doi: 10.1007/s11121-017-0770-8.
- Results publication: PubMed 26441044Newton NC, Barrett EL, Castellanos-Ryan N, Kelly E, Champion KE, Stapinski L, Conrod PJ, Slade T, Nair N, Teesson M. The validity of the Substance Use Risk Profile Scale (SURPS) among Australian adolescents. Addict Behav. 2016 Feb;53:23-30. doi: 10.1016/j.addbeh.2015.09.015. Epub 2015 Sep 25.
- Results publication: PubMed 19683400Woicik PA, Stewart SH, Pihl RO, Conrod PJ. The Substance Use Risk Profile Scale: a scale measuring traits linked to reinforcement-specific substance use profiles. Addict Behav. 2009 Dec;34(12):1042-55. doi: 10.1016/j.addbeh.2009.07.001. Epub 2009 Jul 8.
- Derived from this study: PubMed 39075465Salgado G, Gaete J, Gana S, Valenzuela D, Araya R. Acceptability, feasibility and fidelity of the culturally adapted version of Unplugged ("Yo Se Lo Que Quiero"), a substance use preventive program among adolescents in Chile: a pilot randomized controlled study. BMC Public Health. 2024 Jul 29;24(1):2026. doi: 10.1186/s12889-024-19499-2.
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Healthy Volunteers
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.
Jorge Gaete, MD PhD principal investigator
Universidad de los Andes, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Yo Sé Lo Que Quiero" programl in people with Substance Use and Adolescent Behavior, run by Universidad de los Andes, Chile at 1 site in Chile.
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 1 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 28 Sep 2020. 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 Chile. 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?
Acceptability of the program by students (time frame: Inmediately Post-intervention). 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 NCT04566627, which also lists 9 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 28 Sep 2020.