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

U

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Status

Not yet enrolling

Conditions

Gambling

Treatments

Behavioral: Unplugged plus gambling component

Study type

Interventional

Funder types

Other

Identifiers

NCT05630157
080.742

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,046 estimated patients

Sex

All

Ages

12 to 14 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,046 participants in 2 patient groups

Unplugged plus gambling component
Experimental group
Description:
The experimental arm will receive the Unplugged curriculum plus a gambling component
Treatment:
Behavioral: Unplugged plus gambling component
Usual curriculum
No Intervention group
Description:
The Usual curriculum arm won't receive any specific prevention program

Trial contacts and locations

0

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Central trial contact

Federica D Vigna-Taglianti, PhD

Data sourced from clinicaltrials.gov

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