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

Gambling Clinical Trial

— GAPUnplugged  

Official title:

Evaluation of Effectiveness of the School-based Substance Use Prevention Program "Unplugged" on Gambling Behaviors Among Adolescents: an Experimental Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05630157
• Other study ID #: 080.742
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
• Contact: Federica D Vigna-Taglianti, PhD
• Phone: +393358088970
• Email: federica.vignataglianti[@]uniupo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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". 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Gambling

Intervention

Behavioral:
• Unplugged 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"	ASL Roma 1

References & Publications (9)

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

Outcome

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)

External Links

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