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

NCT05630157 | Unknown

• 1 other identifier: 080.742
• Study Type: interventional
• Target: 3,046
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gambling

Keywords

Gambling; Prevention; School; Uplugged; Students; Effectiveness; Adolescents

Outcome Measures

Primary Outcomes (1)

• Prevalence of gambling behaviors

  past 30 days frequency of gambling behaviors

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

Secondary Outcomes (6)

• Prevalence of at-risk gambling behavior

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

• Beliefs about gambling

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

• Attitudes towards gambling

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

• Refusal skills for gambling

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

• Normative perceptions on gambling

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

Study Arms (2)

Unplugged plus gambling component

EXPERIMENTAL

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

Behavioral: Unplugged plus gambling component

Usual curriculum

NO INTERVENTION

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

Interventions

Unplugged plus gambling component BEHAVIORAL

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

Unplugged plus gambling component

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi del Piemonte Orientale Amedeo Avogadro: lead
• ASL Roma 1: collaborator

Related Publications (10)

• 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.

  PMID: 17084887 RESULT

• 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.

  PMID: 18657569 RESULT

• 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.

  PMID: 20080363 RESULT

• 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.

  PMID: 22266087 RESULT

• 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.

  PMID: 33245788 RESULT

• 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.

  PMID: 34509736 RESULT

• 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.

  PMID: 21563171 RESULT

• 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.

  PMID: 22538180 RESULT

• 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.

  PMID: 14634316 RESULT

• Vigna-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.

  PMID: 38416313 DERIVED

Related Links

• website including information on Unplugged program, evaluation study and effectiveness
• page of EMCDDA website describing the effectiveness of Unplugged

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Study Officials

• Federica D Vigna-Taglianti, PhD

  University of Eastern Piedmont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica D Vigna-Taglianti, PhD

CONTACT

+393358088970; federica.vignataglianti@uniupo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: non randomized cluster controlled trial

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: November 21, 2022
• Primary Completion: November 21, 2023
• Study Completion: December 31, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: as soon as databases will be ready and statistical analyses will be initiated
• Access Criteria: specific request to principal investigator