Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 3:15 AM
Study NCT ID:
NCT05630157
Status:
UNKNOWN
Last Update Posted:
2022-11-29
First Post:
2022-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Effectiveness of the Unplugged Program on Gambling Among Adolescents (GAPUnplugged)
Sponsor:
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Organization:
Study Overview
Official Title:
Evaluation of Effectiveness of the School-based Substance Use Prevention Program "Unplugged" on Gambling Behaviors Among Adolescents: an Experimental Controlled Study
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAPUnplugged
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: