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

Sponsor

Università degli Studi del Piemonte Orientale "Amedeo Avogadro" (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05630157

Collaborator

ASL Roma 1 (Other)

3,046

Enrollment

Arms

13.3

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gambling	Behavioral: Unplugged plus gambling component	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3046 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

non randomized cluster controlled trialnon randomized cluster controlled trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 21, 2022

Anticipated Primary Completion Date :

Nov 21, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Unplugged plus gambling component The experimental arm will receive the Unplugged curriculum plus a gambling component	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 Other Names: GAPUnplugged
No Intervention: Usual curriculum The Usual curriculum arm won't receive any specific prevention program

Arm

Intervention/Treatment

Experimental: Unplugged plus gambling component

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

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

Other Names:

GAPUnplugged

No Intervention: Usual curriculum

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

Outcome Measures

Primary Outcome Measures

Prevalence of gambling behaviors [follow-up (4-8 weeks after completion of intervention)]
past 30 days frequency of gambling behaviors

Secondary Outcome Measures

Prevalence of at-risk gambling behavior [follow-up (4-8 weeks after completion of intervention)]
past 30 days frequency of at risk indicator according to the definition of SOGS-RA (Wiebe 2000)
Beliefs about gambling [follow-up (4-8 weeks after completion of intervention)]
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 [follow-up (4-8 weeks after completion of intervention)]
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 [follow-up (4-8 weeks after completion of intervention)]
proportion of pupils answering they will refuse vs accept the proposal of gambling from a friend (three scenarios)
Normative perceptions on gambling [follow-up (4-8 weeks after completion of intervention)]
proportion of pupils scoring as >50% the proportion of friends or people of their age who gamble
Risk perceptions on gambling [follow-up (4-8 weeks after completion of intervention)]
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.."

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 14 Years

Sexes Eligible for Study:

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:

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.