CClinicalTrials.gg
Status unknownNCT05630157GAPUnpluggedUpdated Nov 29, 2022

Evaluation of Effectiveness of the Unplugged Program on Gambling Among Adolescents (GAPUnplugged)

An interventional study of Unplugged plus gambling component in Gambling, sponsored by Università degli Studi del Piemonte Orientale Amedeo Avogadro. Status unknown. Open to participants aged 12 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.

Sponsored by Università degli Studi del Piemonte Orientale Amedeo Avogadro · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
3,046
Allocation
Non-randomized
Ages
12 Years to 14 Years
Sex
All
01

Study 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". 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:

  1. 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;
  2. 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.

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Conditions studied

  • Gambling

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Keywords

  • Gambling
  • Prevention
  • School
  • Uplugged
  • Students
  • Effectiveness
  • Adolescents
03

In context

Gambling

147 studies on the registry are indexed under Gambling; 35 are open to participants now.

This study's planned enrollment of 3,046 is above the median of 65 across 119 interventional studies indexed under Gambling.

Browse Gambling studies →

Lead sponsor

Università degli Studi del Piemonte Orientale Amedeo Avogadro is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,046 participants (estimated)

Study arms

  • Experimental
    Unplugged plus gambling component

    The experimental arm will receive the Unplugged curriculum plus a gambling component

    Behavioral: Unplugged plus gambling component

  • No intervention
    Usual curriculum

    The Usual curriculum arm won't receive any specific prevention program

Interventions

  • BehavioralUnplugged plus gambling component

    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

    Also known as: GAPUnplugged

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What researchers measure

Primary outcomes

  1. Prevalence of gambling behaviors

    past 30 days frequency of gambling behaviors

    Time frame: follow-up (4-8 weeks after completion of intervention)

Secondary outcomes

  1. Prevalence of at-risk gambling behavior

    past 30 days frequency of at risk indicator according to the definition of SOGS-RA (Wiebe 2000)

    Time frame: follow-up (4-8 weeks after completion of intervention)

  2. 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").

    Time frame: follow-up (4-8 weeks after completion of intervention)

  3. 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").

    Time frame: follow-up (4-8 weeks after completion of intervention)

  4. Refusal skills for gambling

    proportion of pupils answering they will refuse vs accept the proposal of gambling from a friend (three scenarios)

    Time frame: follow-up (4-8 weeks after completion of intervention)

  5. Normative perceptions on gambling

    proportion of pupils scoring as \>50% the proportion of friends or people of their age who gamble

    Time frame: follow-up (4-8 weeks after completion of intervention)

  6. 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.."

    Time frame: follow-up (4-8 weeks after completion of intervention)

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Study locations

No study locations are listed for this record.

08

References and documents

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 17084887 ↗
  • 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 18657569 ↗
  • Faggiano 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 20080363 ↗
  • Gabrhelik 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 22266087 ↗
  • Sanchez 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 33245788 ↗
  • Vigna-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 34509736 ↗
  • Foxcroft 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 21563171 ↗
  • Catalano 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 22538180 ↗
  • Wiebe 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 14634316 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05630157
Lead sponsor
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborators
ASL Roma 1
Responsible party
Federica Vigna Taglianti (professor, Università degli Studi del Piemonte Orientale Amedeo Avogadro) — Principal investigator
First posted
Nov 29, 2022
Start date
Nov 21, 2022 (estimated)
Primary completion
Nov 21, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Nov 29, 2022

Study contacts

Federica D Vigna-Taglianti, PhD
Contact
federica.vignataglianti@uniupo.it
+393358088970
Federica D Vigna-Taglianti, PhD
principal investigator · University of Eastern Piedmont

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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