Gambling Clinical Trial
— GAPUnpluggedOfficial 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.
Status | Not yet recruiting |
Enrollment | 3046 |
Est. completion date | December 31, 2023 |
Est. primary completion date | November 21, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 14 Years |
Eligibility | 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: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Università degli Studi del Piemonte Orientale "Amedeo Avogadro" | ASL Roma 1 |
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. — View Citation
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 — View Citation
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.yp — View Citation
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 pro — View Citation
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. Review. — View Citation
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: 10.10 — View Citation
Sanchez ZM, Valente JY, Galvão 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 — View Citation
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 random — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of gambling behaviors | past 30 days frequency of gambling behaviors | follow-up (4-8 weeks after completion of intervention) | |
Secondary | Prevalence of at-risk gambling behavior | past 30 days frequency of at risk indicator according to the definition of SOGS-RA (Wiebe 2000) | follow-up (4-8 weeks after completion of intervention) | |
Secondary | 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"). | follow-up (4-8 weeks after completion of intervention) | |
Secondary | 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"). | follow-up (4-8 weeks after completion of intervention) | |
Secondary | Refusal skills for gambling | proportion of pupils answering they will refuse vs accept the proposal of gambling from a friend (three scenarios) | follow-up (4-8 weeks after completion of intervention) | |
Secondary | Normative perceptions on gambling | proportion of pupils scoring as >50% the proportion of friends or people of their age who gamble | follow-up (4-8 weeks after completion of intervention) | |
Secondary | 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.." | follow-up (4-8 weeks after completion of intervention) |
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