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

November 17, 2022 updated by: Federica Vigna Taglianti, Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Anticipated)

3046

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of gambling behaviors
Time Frame: follow-up (4-8 weeks after completion of intervention)
past 30 days frequency of gambling behaviors
follow-up (4-8 weeks after completion of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of at-risk gambling behavior
Time Frame: 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)
follow-up (4-8 weeks after completion of intervention)
Beliefs about gambling
Time Frame: 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").
follow-up (4-8 weeks after completion of intervention)
Attitudes towards gambling
Time Frame: 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").
follow-up (4-8 weeks after completion of intervention)
Refusal skills for gambling
Time Frame: 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)
follow-up (4-8 weeks after completion of intervention)
Normative perceptions on gambling
Time Frame: 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
follow-up (4-8 weeks after completion of intervention)
Risk perceptions on gambling
Time Frame: 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.."
follow-up (4-8 weeks after completion of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Collaborators

ASL Roma 1

Investigators

  • Principal Investigator: Federica D Vigna-Taglianti, PhD, University of Eastern Piedmont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 21, 2022

Primary Completion (Anticipated)

November 21, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080.742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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