GamblingGAPUnpluggedNCT05630157
Evaluation of Effectiveness of the Unplugged Program on Gambling Among Adolescents (GAPUnplugged)
A study testing Unplugged plus gambling component in people with Gambling, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro.
Trial summary
The main aim of this study is to assess the effectiveness of a new component on gambling prevention to be added to the evidence-based school based prevention curriculum "Unplugged". Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Gambling
- What is being tested?
- Unplugged plus gambling component
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,046 participants
- Where
- No sites listed yet
- Study dates
- 21 Nov 2022to 31 Dec 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools/classes in which at least one teacher has participated in the training course for Unplugged teachers, either in the past or in the weeks before the beginning of the study.
- Participation of already trained teachers in a booster training session on the gambling component.
Who cannot join
- classes which already started the Unplugged program in fall 2022, before the start of the study.
- pupils whose caregivers expressed refusal to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Effectiveness of the School-based Substance Use Prevention Program "Unplugged" on Gambling Behaviors Among Adolescents: an Experimental Controlled Study
The main aim of this study is to assess the effectiveness of a new component on gambling prevention to be added to the evidence-based school based prevention curriculum "Unplugged". The evaluation of effectiveness will be performed by conducting a non-randomized cluster controlled trial in classes of pupils 12 to 14 years old. Classes will be allocated to the intervention arm (receving Unplugged + the gambling component) or to the control arm (usual curriculum, no specific intervention).
The intervention includes 12 prevention units and a 13th unit focused on gambling. It will be carried out by Unplugged teachers trained in a specific training course. Data collection will take place before and after the intervention through a standardized questionnaire developed ad hoc and containing previously validated questions.
Read the detailed description
The goals of the present non-randomized cluster controlled experimental trial (CCT) with follow-up at 4-8 weeks after the end of the intervention are:
- to assess the effectiveness of a gambling-focused component added to the Unplugged prevention curriculum on: gambling behaviors, knowledge, attitudes, risk perceptions, beliefs, refusal skills, and normative perceptions;
- to estimate the prevalence of gambling behaviors among Italian adolescents aged 12 to 14 years.
Unplugged is a school-based curriculum aimed to prevent tobacco, alcohol and drugs use among adolescents, developed and tested in the EUDap trial (www.eudap.net). It was demonstrated to be effective in several studies (Faggiano 2007; 2008; 2010; Gabrhelik 2012; Sanchez 2021; Vigna-Taglianti 2021) and included among evidence-based prevention programs (EMCDDA; Foxcroft 2011; Catalano 2012).
Secondary schools in Lazio, Piedmont and other Italian regions will be invited to take part in the study. Participation is voluntary for both the intervention and the control group. The schools participating in the study will inform caregivers and ask their consent for the participationof students and the data collection. Only students whose caregivers have given consent to participate will be involved in the study which will last about 7 months. The first questionnaire will be administered between November and December 2022 both in the control and the intervention group. Afterwards, the intervention group will received the 12 units of the Unplugged program and the gambling component, for about 3 months. Finally, after 4 to 8 weeks from the completion of the program, the same evaluation questionnaire will be administeres both in the control and in the intervention classes.
The questionnaire will be anonymous and will report only a pseudo-anonymization code for linkage of baseline and follow-up data. At the end of the survey, data will be analyzed in aggregated and anonymized form.
- Conditions
- Gambling
- Being tested
- Unplugged plus gambling component
- Keywords
- Gambling, Prevention, School, Uplugged, Students, Effectiveness, Adolescents
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unplugged plus gambling componentBehavioural
Also called GAPUnplugged
12 units/lessons of the Unplugged prevention curriculum plus a gambling component including specific gambling contents in units 3-4-5-7-9 and a 13th unit based on probability and mathematical concepts taught through an online simulator
| Study group | Role | What they receive |
|---|---|---|
| Unplugged plus gambling component | Experimental | The experimental arm will receive the Unplugged curriculum plus a gambling component Receives: Behavioral: Unplugged plus gambling component |
| Usual curriculum | No intervention | The Usual curriculum arm won't receive any specific prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of gambling behaviors
past 30 days frequency of gambling behaviors
Measured: follow-up (4-8 weeks after completion of intervention)
Secondary outcomes (6)
Prevalence of at-risk gambling behavior
past 30 days frequency of at risk indicator according to the definition of SOGS-RA (Wiebe 2000)
Measured: follow-up (4-8 weeks after completion of intervention)
Beliefs about gambling
score of the 7 items scale assessing false beliefs concerning gambling (e.g. "If I gamble often, I have a greater chance of winning").
Measured: follow-up (4-8 weeks after completion of intervention)
Attitudes towards gambling
score of the 6 items scale assessing attitudes about gambling by asking "What do you think about gambling" (e.g. "I think gambling is fun").
Measured: follow-up (4-8 weeks after completion of intervention)
Refusal skills for gambling
proportion of pupils answering they will refuse vs accept the proposal of gambling from a friend (three scenarios)
Measured: follow-up (4-8 weeks after completion of intervention)
Normative perceptions on gambling
proportion of pupils scoring as >50% the proportion of friends or people of their age who gamble
Measured: follow-up (4-8 weeks after completion of intervention)
Risk perceptions on gambling
proportion of pupils with high vs low risk perceptions towards gambling as measured by a question asking "How much do you think people arm themselves by gambling to.."
Measured: follow-up (4-8 weeks after completion of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start21 Nov 2022 (estimated)
- Primary completion21 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for GamblingStudies 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 cluster controlled trial
- Masking
- None (open label)
- Enrolment
- 3,046 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Sponsor type
- University, hospital or other
- Collaborators
- ASL Roma 1
- Responsible party
- Principal investigator, Federica Vigna Taglianti, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Investigators
- Federica D Vigna-Taglianti, PhD, Principal investigator, University of Eastern Piedmont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630157
- Sponsor's protocol ID
- 080.742
- Acronym
- GAPUnplugged
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will made available for other researchers under specific request, specifying the aim. Data will be generally provided as aggregated. In case of common scientific framework, data will be provided as individual.
Publications
Faggiano 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 17084887Faggiano 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 20080363Gabrhelik R, Duncan A, Miovsky M, Furr-Holden CD, Stastna L, Jurystova L. "Unplugged": a school-based randomized control trial to prevent and reduce adolescent substance use in the Czech Republic. Drug Alcohol Depend. 2012 Jul 1;124(1-2):79-87. doi: 10.1016/j.drugalcdep.2011.12.010. Epub 2012 Jan 21.
PubMed 22266087Sanchez ZM, Valente JY, Galvao PP, Gubert FA, Melo MHS, Caetano SC, Mari JJ, Cogo-Moreira H. A cluster randomized controlled trial evaluating the effectiveness of the school-based drug prevention program #Tamojunto2.0. Addiction. 2021 Jun;116(6):1580-1592. doi: 10.1111/add.15358. Epub 2021 Jan 28.
PubMed 33245788Vigna-Taglianti F, Mehanovic E, Alesina M, Damjanovic L, Ibanga A, Pwajok J, Prichard G, van der Kreeft P, Virk HK; Unplugged Nigeria Coordination Group. Effects of the "Unplugged" school-based substance use prevention program in Nigeria: A cluster randomized controlled trial. Drug Alcohol Depend. 2021 Nov 1;228:108966. doi: 10.1016/j.drugalcdep.2021.108966. Epub 2021 Aug 28.
PubMed 34509736Foxcroft DR, Tsertsvadze A. Universal school-based prevention programs for alcohol misuse in young people. Cochrane Database Syst Rev. 2011 May 11;(5):CD009113. doi: 10.1002/14651858.CD009113.
PubMed 21563171Catalano RF, Fagan AA, Gavin LE, Greenberg MT, Irwin CE Jr, Ross DA, Shek DT. Worldwide application of prevention science in adolescent health. Lancet. 2012 Apr 28;379(9826):1653-64. doi: 10.1016/S0140-6736(12)60238-4. Epub 2012 Apr 25.
PubMed 22538180Wiebe JM, Cox BJ, Mehmel BG. The South Oaks Gambling Screen Revised for Adolescents (SOGS-RA): further psychometric findings from a community sample. J Gambl Stud. 2000 Autumn;16(2-3):275-88. doi: 10.1023/a:1009489132628.
PubMed 14634316Vigna-Taglianti FD, Martorana M, Viola E, Renna M, Vadrucci S, Sciutto A, Andra C, Mehanovic E, Ginechesi M, Vullo C, Ceccano A, Casella P, Faggiano F; GAPUnplugged Coordination Group. Evaluation of Effectiveness of the Unplugged Program on Gambling Behaviours among Adolescents: Study Protocol of the Experimental Controlled Study "GAPUnplugged". J Prev (2022). 2024 Jun;45(3):405-429. doi: 10.1007/s10935-024-00772-4. Epub 2024 Feb 28.
PubMed 38416313
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of the School-based Substance Use Prevention Program "Unplugged" on Gambling Behaviors Among Adolescents: an Experimental Controlled Study
- ClinicalTrials.gov ID
- NCT05630157
- Acronym / sponsor ID
- GAPUnplugged / 080.742
- Conditions
- Gambling
- Keywords
- Gambling, Prevention, School, Uplugged, Students, Effectiveness, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,046 participants (estimated)
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo AvogadroUniversity, hospital or other
- Collaborators
- ASL Roma 1
- Study start
- 21 Nov 2022 (estimated)
- Primary completion
- 21 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Nov 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.
The main aim of this study is to assess the effectiveness of a new component on gambling prevention to be added to the evidence-based school based prevention curriculum "Unplugged". The evaluation of effectiveness will be performed by conducting a non-randomized cluster controlled trial in classes of pupils 12 to 14 years old. Classes will be allocated to the intervention arm (receving Unplugged + the gambling component) or to the control arm (usual curriculum, no specific intervention).
The intervention includes 12 prevention units and a 13th unit focused on gambling. It will be carried out by Unplugged teachers trained in a specific training course. Data collection will take place before and after the intervention through a standardized questionnaire developed ad hoc and containing previously validated questions.
Detailed description
The goals of the present non-randomized cluster controlled experimental trial (CCT) with follow-up at 4-8 weeks after the end of the intervention are:
- to assess the effectiveness of a gambling-focused component added to the Unplugged prevention curriculum on: gambling behaviors, knowledge, attitudes, risk perceptions, beliefs, refusal skills, and normative perceptions;
- to estimate the prevalence of gambling behaviors among Italian adolescents aged 12 to 14 years.
Unplugged is a school-based curriculum aimed to prevent tobacco, alcohol and drugs use among adolescents, developed and tested in the EUDap trial (www.eudap.net). It was demonstrated to be effective in several studies (Faggiano 2007; 2008; 2010; Gabrhelik 2012; Sanchez 2021; Vigna-Taglianti 2021) and included among evidence-based prevention programs (EMCDDA; Foxcroft 2011; Catalano 2012).
Secondary schools in Lazio, Piedmont and other Italian regions will be invited to take part in the study. Participation is voluntary for both the intervention and the control group. The schools participating in the study will inform caregivers and ask their consent for the participationof students and the data collection. Only students whose caregivers have given consent to participate will be involved in the study which will last about 7 months. The first questionnaire will be administered between November and December 2022 both in the control and the intervention group. Afterwards, the intervention group will received the 12 units of the Unplugged program and the gambling component, for about 3 months. Finally, after 4 to 8 weeks from the completion of the program, the same evaluation questionnaire will be administeres both in the control and in the intervention classes.
The questionnaire will be anonymous and will report only a pseudo-anonymization code for linkage of baseline and follow-up data. At the end of the survey, data will be analyzed in aggregated and anonymized form.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non randomized cluster controlled trial
| Arm | Type | Receives |
|---|---|---|
| Unplugged plus gambling component | Experimental | Behavioral: Unplugged plus gambling componentThe experimental arm will receive the Unplugged curriculum plus a gambling component |
| Usual curriculum | No intervention | –The Usual curriculum arm won't receive any specific prevention program |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Schools/classes in which at least one teacher has participated in the training course for Unplugged teachers, either in the past or in the weeks before the beginning of the study.
- Participation of already trained teachers in a booster training session on the gambling component.
Key exclusion criteria (2 listed)
- classes which already started the Unplugged program in fall 2022, before the start of the study.
- pupils whose caregivers expressed refusal to participate in the study.
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 |
|---|---|---|
| Unplugged plus gambling componentAlso: GAPUnplugged12 units/lessons of the Unplugged prevention curriculum plus a gambling component including specific gambling contents in units 3-4-5-7-9 and a 13th unit based on probability and mathematical concepts taught through an online simulator | Behavioural | Unplugged plus gambling component |
Primary outcome
Prevalence of gambling behaviors
Time frame: follow-up (4-8 weeks after completion of intervention)
past 30 days frequency of gambling behaviors
6 secondary outcomes
Prevalence of at-risk gambling behavior
Time frame: follow-up (4-8 weeks after completion of intervention)
Beliefs about gambling
Time frame: follow-up (4-8 weeks after completion of intervention)
Attitudes towards gambling
Time frame: follow-up (4-8 weeks after completion of intervention)
Refusal skills for gambling
Time frame: follow-up (4-8 weeks after completion of intervention)
Normative perceptions on gambling
Time frame: follow-up (4-8 weeks after completion of intervention)
Risk perceptions on gambling
Time frame: follow-up (4-8 weeks after completion of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- 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 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 22266087Gabrhelik R, Duncan A, Miovsky M, Furr-Holden CD, Stastna L, Jurystova L. "Unplugged": a school-based randomized control trial to prevent and reduce adolescent substance use in the Czech Republic. Drug Alcohol Depend. 2012 Jul 1;124(1-2):79-87. doi: 10.1016/j.drugalcdep.2011.12.010. Epub 2012 Jan 21.
- Results publication: PubMed 33245788Sanchez ZM, Valente JY, Galvao PP, Gubert FA, Melo MHS, Caetano SC, Mari JJ, Cogo-Moreira H. A cluster randomized controlled trial evaluating the effectiveness of the school-based drug prevention program #Tamojunto2.0. Addiction. 2021 Jun;116(6):1580-1592. doi: 10.1111/add.15358. Epub 2021 Jan 28.
- Results publication: PubMed 34509736Vigna-Taglianti F, Mehanovic E, Alesina M, Damjanovic L, Ibanga A, Pwajok J, Prichard G, van der Kreeft P, Virk HK; Unplugged Nigeria Coordination Group. Effects of the "Unplugged" school-based substance use prevention program in Nigeria: A cluster randomized controlled trial. Drug Alcohol Depend. 2021 Nov 1;228:108966. doi: 10.1016/j.drugalcdep.2021.108966. Epub 2021 Aug 28.
- Results publication: PubMed 21563171Foxcroft DR, Tsertsvadze A. Universal school-based prevention programs for alcohol misuse in young people. Cochrane Database Syst Rev. 2011 May 11;(5):CD009113. doi: 10.1002/14651858.CD009113.
- Results publication: PubMed 22538180Catalano RF, Fagan AA, Gavin LE, Greenberg MT, Irwin CE Jr, Ross DA, Shek DT. Worldwide application of prevention science in adolescent health. Lancet. 2012 Apr 28;379(9826):1653-64. doi: 10.1016/S0140-6736(12)60238-4. Epub 2012 Apr 25.
- Results publication: PubMed 14634316Wiebe JM, Cox BJ, Mehmel BG. The South Oaks Gambling Screen Revised for Adolescents (SOGS-RA): further psychometric findings from a community sample. J Gambl Stud. 2000 Autumn;16(2-3):275-88. doi: 10.1023/a:1009489132628.
- Derived from this study: PubMed 38416313Vigna-Taglianti FD, Martorana M, Viola E, Renna M, Vadrucci S, Sciutto A, Andra C, Mehanovic E, Ginechesi M, Vullo C, Ceccano A, Casella P, Faggiano F; GAPUnplugged Coordination Group. Evaluation of Effectiveness of the Unplugged Program on Gambling Behaviours among Adolescents: Study Protocol of the Experimental Controlled Study "GAPUnplugged". J Prev (2022). 2024 Jun;45(3):405-429. doi: 10.1007/s10935-024-00772-4. Epub 2024 Feb 28.
- website including information on Unplugged program, evaluation study and effectivenessLink provided by the sponsor.
- page of EMCDDA website describing the effectiveness of UnpluggedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will made available for other researchers under specific request, specifying the aim. Data will be generally provided as aggregated. In case of common scientific framework, data will be provided as individual.
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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.
Federica D Vigna-Taglianti, PhD principal investigator
University of Eastern Piedmont
Questions about this trial
What is this clinical trial studying?
A study testing Unplugged plus gambling component in people with Gambling, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Federica D Vigna-Taglianti, PhD (+393358088970, federica.vignataglianti@uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of gambling behaviors (time frame: follow-up (4-8 weeks after completion of intervention)). 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 NCT05630157, which also lists 10 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 29 Nov 2022.