Behavior, AddictivePSIDUPNCT05442294
"Juego de LLaves": Study Protocol of a Universal School-based Drug Use Prevention Program (PSIDUP)
A study testing Juego de Llaves in people with Behavior, Addictive and Adolescent - Emotional Problem, run by Susana Al-Halabí at 1 site in Spain.
Trial summary
"Juego de Llaves" is a universal school-based drug prevention program for adolescents aged 12-15 years. The outcome evaluation is critical to determine the quality of preventive interventions. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Addictive, Adolescent - Emotional Problem, Alcohol Abuse
- What is being tested?
- Juego de Llaves
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 30 Dec 2025
- 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools having secondary education.
- Schools located in Spain.
- Schools willing to participate under the conditions of the study before randomization.
Who cannot join
- Schools having other interventions with a strong package on substance use prevention targeted the same grades.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Grupo de Conductas Adictivas, University of Oviedo
Oviedo, Principality of Asturias, 33006
About this study
Official title: "Juego de Llaves", a Universal School-based Drug Use Prevention Program: A Non-Randomized Control Cluster Trial for the Evaluation of Effectiveness Among Adolescents in Spain (PISUP)
"Juego de Llaves" is a universal school-based drug prevention program for adolescents aged 12-15 years. The outcome evaluation is critical to determine the quality of preventive interventions. This protocol describes the full protocol of the evaluation design, instruments, randomization procedure, follow-ups, and primary outcomes. Method: Non-Randomized Control Cluster Trial in a set of Spanish school centers at the compulsory secondary education level, with follow-ups at 12-, 24- and 36-months. Participants will be allocated to an experimental or control (no intervention) group. Using an electronic ad-hoc designed App, a battery of instruments will be used to assess addictive behaviors, sociodemographic variables, school climate and other transdiagnostic psychological variables. A piloting test will be conducted to test the implementation protocol and to calculate the sample size needed for the outcome evaluation. After implementing the program, longitudinal statistical approaches will be used to inform on the intervention efficacy and potential moderators and mediators. There is a lack of effectiveness assessments of school prevention programs, and it is expected that this protocol will expedite the monitoring and ongoing evaluation in prevention.
- Conditions
- Behavior, Addictive, Adolescent - Emotional Problem, Alcohol Abuse, Smoking Behaviors, Adolescent Behavior, Psychological
- Being tested
- Juego de Llaves
- Keywords
- Adolescents, Addictive behaviors, Evaluation, Universal school-based prevention, Transdiagnostic approach
- Medical subject headings
- Behavior, Addictive, Alcoholism, Smoking, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juego de LlavesBehavioural
The main goal of this program is to prevent substance use and engagement in other addictive behaviors. It is intended to be delivered by teachers in a six to twelve session format through different modules that cover the following areas: emotional regulation, cognitive strategies, social interaction, free time, education on drugs and life values
| Study group | Role | What they receive |
|---|---|---|
| Juego de Llaves group | Experimental | This group will receive the prevention program during the academic year in school hours. The prevention program is called Juego de Llaves.
The main goal of this program is to prevent substance use and engagement in other addictive behaviors. It is intended to be delivered by teachers in a six to twelve session format through different modules that cover the following areas: emotional regulation, cognitive strategies, social interaction, free time, education on drugs and life values Receives: Behavioral: Juego de Llaves |
| Control group | No intervention | The control group will receive the usual teaching activities regarding substance use prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use: Tobacco
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Measured: Past 30-day period
Substance use: Alcohol
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Measured: Past 30-day period
Substance use: Cannabis
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Measured: Past 30-day period
Non-substance use behavior: Gaming
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Measured: Past 30-day period
Non-substance use behavior: Gambling
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Measured: Past 30-day period
Reinforcement ratio
Ad-hoc questionnaire (SAUPI; unpublished)
Measured: Past-year period
Consecuences of addictive behaviors
ARSS-SUV (adapted from Murphy et al., 2005)
Measured: Past 30-day period
Secondary outcomes (5)
Resilience
The Child and Youth Resilience Measure, CYMR (Resilience Research Centre, 2018)
Measured: Past 30-day period
Behavioral problemas
Strengths and Difficulties Questionnaire (25-item version), SDQ (Ortuño-Sierra et al., 2018)
Measured: Past 30-day period
Emotion regulation
The Emotional Regulation Questionnaire - adolescents, ERQ-CA (Navarro et al., 2018)
Measured: Past 30-day period
Suicidal behavior
The Paykel Suicide Scale, PSS (Fonseca-Pedrero et al., 2018)
Measured: Past 30-day period
Impulsivity
The Scale of Impulsivity for Children and Adolescents BUPPS-P-NA (Caneto et al., 2020)
Measured: Past 30-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, AddictiveStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-Randomized Control Cluster Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Susana Al-Halabí
- Sponsor type
- University, hospital or other
- Collaborators
- United Nations Office on Drugs and Crime (UNODC), Asociación Proyecto Hombre
- Responsible party
- Sponsor-investigator, Susana Al-Halabí, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442294
- Sponsor's protocol ID
- 2021G090 / FUO-22- 023
- Acronym
- PSIDUP
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Juego de Llaves", a Universal School-based Drug Use Prevention Program: A Non-Randomized Control Cluster Trial for the Evaluation of Effectiveness Among Adolescents in Spain (PISUP)
- ClinicalTrials.gov ID
- NCT05442294
- Acronym / sponsor ID
- PSIDUP / 2021G090 / FUO-22- 023
- Conditions
- Behavior, Addictive, Adolescent - Emotional Problem, Alcohol Abuse, Smoking Behaviors, Adolescent Behavior, Psychological
- Keywords
- Adolescents, Addictive behaviors, Evaluation, Universal school-based prevention, Transdiagnostic approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Susana Al-HalabíUniversity, hospital or other
- Collaborators
- United Nations Office on Drugs and Crime (UNODC), Asociación Proyecto Hombre
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Jul 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.
"Juego de Llaves" is a universal school-based drug prevention program for adolescents aged 12-15 years. The outcome evaluation is critical to determine the quality of preventive interventions. This protocol describes the full protocol of the evaluation design, instruments, randomization procedure, follow-ups, and primary outcomes. Method: Non-Randomized Control Cluster Trial in a set of Spanish school centers at the compulsory secondary education level, with follow-ups at 12-, 24- and 36-months. Participants will be allocated to an experimental or control (no intervention) group. Using an electronic ad-hoc designed App, a battery of instruments will be used to assess addictive behaviors, sociodemographic variables, school climate and other transdiagnostic psychological variables. A piloting test will be conducted to test the implementation protocol and to calculate the sample size needed for the outcome evaluation. After implementing the program, longitudinal statistical approaches will be used to inform on the intervention efficacy and potential moderators and mediators. There is a lack of effectiveness assessments of school prevention programs, and it is expected that this protocol will expedite the monitoring and ongoing evaluation in prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-Randomized Control Cluster Trial
| Arm | Type | Receives |
|---|---|---|
| Juego de Llaves group | Experimental | Behavioral: Juego de LlavesThis group will receive the prevention program during the academic year in school hours. The prevention program is called Juego de Llaves. The main goal of this program is to prevent substance use and engagement in other addictive behaviors. It is intended to be delivered by teachers in a six to twelve session format through different modules that cover the following areas: emotional regulation, cognitive strategies, social interaction, free time, education on drugs and life values |
| Control group | No intervention | –The control group will receive the usual teaching activities regarding substance use prevention. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Schools having secondary education.
- Schools located in Spain.
- Schools willing to participate under the conditions of the study before randomization.
Key exclusion criteria (1 listed)
- Schools having other interventions with a strong package on substance use prevention targeted the same grades.
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 |
|---|---|---|
| Juego de LlavesThe main goal of this program is to prevent substance use and engagement in other addictive behaviors. It is intended to be delivered by teachers in a six to twelve session format through different modules that cover the following areas: emotional regulation, cognitive strategies, social interaction, free time, education on drugs and life values | Behavioural | Juego de Llaves group |
Primary outcome
Substance use: Tobacco
Time frame: Past 30-day period
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Substance use: Alcohol
Time frame: Past 30-day period
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Substance use: Cannabis
Time frame: Past 30-day period
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Non-substance use behavior: Gaming
Time frame: Past 30-day period
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Non-substance use behavior: Gambling
Time frame: Past 30-day period
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Reinforcement ratio
Time frame: Past-year period
Ad-hoc questionnaire (SAUPI; unpublished)
Consecuences of addictive behaviors
Time frame: Past 30-day period
ARSS-SUV (adapted from Murphy et al., 2005)
5 secondary outcomes
Resilience
Time frame: Past 30-day period
Behavioral problemas
Time frame: Past 30-day period
Emotion regulation
Time frame: Past 30-day period
Suicidal behavior
Time frame: Past 30-day period
Impulsivity
Time frame: Past 30-day period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juego de Llaves in people with Behavior, Addictive and Adolescent - Emotional Problem, run by Susana Al-Halabí 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 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: status not confirmed, as of the sponsor's last update on 1 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susana Al-Halabí, PhD (+34 985104199, alsusana@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use: Tobacco (time frame: Past 30-day period). The study lists 7 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 1 Jul 2022.