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

Primary Purpose

Gambling

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Unplugged plus gambling component
Sponsored by
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gambling focused on measuring Gambling, Prevention, School, Uplugged, Students, Effectiveness, Adolescents

Eligibility Criteria

12 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Unplugged plus gambling component

    Usual curriculum

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Prevalence of gambling behaviors
    past 30 days frequency of gambling behaviors

    Secondary Outcome Measures

    Prevalence of at-risk gambling behavior
    past 30 days frequency of at risk indicator according to the definition of SOGS-RA (Wiebe 2000)
    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").
    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").
    Refusal skills for gambling
    proportion of pupils answering they will refuse vs accept the proposal of gambling from a friend (three scenarios)
    Normative perceptions on gambling
    proportion of pupils scoring as >50% the proportion of friends or people of their age who gamble
    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.."

    Full Information

    First Posted
    November 17, 2022
    Last Updated
    November 17, 2022
    Sponsor
    Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
    Collaborators
    ASL Roma 1
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05630157
    Brief Title
    Evaluation of Effectiveness of the Unplugged Program on Gambling Among Adolescents (GAPUnplugged)
    Acronym
    GAPUnplugged
    Official Title
    Evaluation of Effectiveness of the School-based Substance Use Prevention Program "Unplugged" on Gambling Behaviors Among Adolescents: an Experimental Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 21, 2022 (Anticipated)
    Primary Completion Date
    November 21, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
    Collaborators
    ASL Roma 1

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gambling
    Keywords
    Gambling, Prevention, School, Uplugged, Students, Effectiveness, Adolescents

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    non randomized cluster controlled trial
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    3046 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Unplugged plus gambling component
    Arm Type
    Experimental
    Arm Description
    The experimental arm will receive the Unplugged curriculum plus a gambling component
    Arm Title
    Usual curriculum
    Arm Type
    No Intervention
    Arm Description
    The Usual curriculum arm won't receive any specific prevention program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Unplugged plus gambling component
    Other Intervention Name(s)
    GAPUnplugged
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Prevalence of gambling behaviors
    Description
    past 30 days frequency of gambling behaviors
    Time Frame
    follow-up (4-8 weeks after completion of intervention)
    Secondary Outcome Measure Information:
    Title
    Prevalence of at-risk gambling behavior
    Description
    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)
    Title
    Beliefs about gambling
    Description
    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)
    Title
    Attitudes towards gambling
    Description
    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)
    Title
    Refusal skills for gambling
    Description
    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)
    Title
    Normative perceptions on gambling
    Description
    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)
    Title
    Risk perceptions on gambling
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Federica D Vigna-Taglianti, PhD
    Phone
    +393358088970
    Email
    federica.vignataglianti@uniupo.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Federica D Vigna-Taglianti, PhD
    Organizational Affiliation
    University of Eastern Piedmont
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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.
    IPD Sharing Time Frame
    as soon as databases will be ready and statistical analyses will be initiated
    IPD Sharing Access Criteria
    specific request to principal investigator
    Citations:
    PubMed Identifier
    17084887
    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.ypmed.2006.09.010. Epub 2006 Nov 3.
    Results Reference
    result
    PubMed Identifier
    18657569
    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 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 Reference
    result
    PubMed Identifier
    20080363
    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 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 Reference
    result
    PubMed Identifier
    22266087
    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: 10.1016/j.drugalcdep.2011.12.010. Epub 2012 Jan 21.
    Results Reference
    result
    PubMed Identifier
    33245788
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    34509736
    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 randomized controlled trial. Drug Alcohol Depend. 2021 Nov 1;228:108966. doi: 10.1016/j.drugalcdep.2021.108966. Epub 2021 Aug 28.
    Results Reference
    result
    PubMed Identifier
    21563171
    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.
    Results Reference
    result
    PubMed Identifier
    22538180
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    14634316
    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. doi: 10.1023/a:1009489132628.
    Results Reference
    result
    Links:
    URL
    http://www.eudap.net
    Description
    website including information on Unplugged program, evaluation study and effectiveness
    URL
    http://www.emcdda.europa.eu/best-practice/xchange/unplugged_en
    Description
    page of EMCDDA website describing the effectiveness of Unplugged

    Learn more about this trial

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

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