Testing efficacy of individual components of substance use prevention interventions

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN78792172
• Date of registration: 12/04/2016
• Prospective Registration: No
• Primary sponsor: Hospital Clinic de Barcelona
• Public title: Testing efficacy of individual components of substance use prevention interventions
• Scientific title: A randomised controlled study to test the effect of individual intervention components on effective mediators for school-based prevention of alcohol abuse and illicit drug use in adolescence
• Date of first enrolment: 01/10/2015
• Target sample size: 1040
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN78792172
• Study type: Interventional
• Study design: Four two-arm parallel-group randomised controlled trials (Prevention)

Countries of recruitment

Canada, Israel, Italy, Netherlands

Contacts

• Name: Fabrizio Faggiano

Key inclusion & exclusion criteria

Inclusion criteria: 1. Students attending public/government schools
2. At least two classes attended by students aged 13-14
3. Not participating in other major prevention intervention for alcohol abuse and/or illicit drug use targeted to the classes of interest
Exclusion criteria: 1. Students with special needs
2. Thsoe whose parents opt out from the study

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Alcohol and substance abuse
Mental and Behavioural Disorders
Alcohol abuse

Intervention(s)

In each participating country, schools are randomised to one of the two groups (6 schools per participating country with two classes each school – 3 schools in the intervention group and 3 in the control group).

Italy
Intervention group: Participants in the intervention group receive two units from Unplugged (original version) about promotion of refusal skills related to alcohol and marijuana. This involves two two-hour interactive classroom-based sessions delivered by previously trained teachers including teacher-led discussions, workbook individual activities and role-plays.
Control group: Participants continue with their usual curriculum. Control group schools will solely participate in the measurement of the study outcomes.

The Netherlands
Intervention group: Participants in the intervention group receive two units from PAS (Prevention of Alcohol use in Adolescence - original version) about promotion of self-control related to alcohol abuse and parents’ alcohol related rules. This involves one digital module delivered by previously trained teachers including short films, animations and classroom-based interactive tasks + one parents’ meeting delivered by health and social/care professionals including a brief presentation, a shared discussion and a flyer to take home. The module lasts for two hours, with one hour for the students’ intervention and one hour for the parents’ intervention.
Control group: Participants continue with their usual curriculum. Control group schools will solely participate in the measurement of the study outcomes.

Israel
Intervention group: Participants in the intervention group receive two units from Unplugged (adapted English version) about reduction of positive attitudes towards alcohol and drugs. This involves two two-hour interactive classroom-based sessions delivered by previously trained teachers including games, teacher-led discussions and group activities.
Control group: Participants continue with their usual curriculum. Contro

Primary Outcome(s)

Italy:
Ability to resist pressure and offers to use alcohol and illicit substances assessed using two items taken from the EU-Dap Questionnaire at baseline and one month after the intervention.

Netherlands:
1. Self-control assessed at using 13 items taken from the PAS questionnaire at baseline and one month after the intervention
2. Parental rules about alcohol use be assessed at baseline and one month after the intervention by 10 items taken from the PAS questionnaire at baseline and one month after the intervention

Israel:
Attitudes towards substance use assessed at baseline and one month after the end of the intervention by 11 items taken from the EU-Dap questionnaire at baseline and one month after the intervention.

Canada:
Coping assessed using the Brief COPE Inventory used for the evaluation of Preventure Programme at baseline and one month after the intervention.

Secondary Outcome(s)

Italy:
1. Self-control assessed using 13 items taken from the PAS questionnaire at baseline and one month after the end of the intervention
2. Parental rules about alcohol use assessed using 10 items taken from the PAS questionnaire at baseline and one month after the end of the intervention
3. Attitudes towards substance use assessed using 11 items taken from the EU-Dap questionnaire at baseline and one month after the end of the intervention
4. Coping assessed using the Brief COPE Inventory used for the evaluation of Preventure Programme at baseline and one month after the end of the intervention

Netherlands:
1. Ability to resist pressure and offers to use alcohol and illicit substances assessed using two items taken from the EU-Dap Questionnaire at baseline and one month after the intervention
2. Attitudes towards substance use assessed using 11 items taken from the EU-Dap questionnaire at baseline and one month after the end of the intervention
3. Coping assessed using the Brief COPE Inventory used for the evaluation of Preventure Programme at baseline and one month after the end of the intervention

Israel:
1. Ability to resist pressure and offers to use alcohol and illicit substances assessed using two items taken from the EU-Dap Questionnaire at baseline and one month after the intervention
2. Self-control assessed at using 13 items taken from the PAS questionnaire at baseline and one month after the intervention
3. Parental rules about alcohol use assessed using 10 items taken from the PAS questionnaire at baseline and one month after the end of the intervention
4. Coping assessed using the Brief COPE Inventory used for the evaluation of Preventure Programme at baseline and one month after the end of the intervention

Canada:
1. Ability to resist pressure and offers to use alcohol and illicit substances assessed using two items taken from the EU-Dap Questionnaire at baseline and one month after the intervention
2. Attitudes towards substance use assessed using 11 items taken from the EU-Dap questionnaire at baseline and one month after the end of the intervention
3. Self-control assessed at using 13 items taken from the PAS questionnaire at baseline and one month after the intervention
4. Parental rules about alcohol use assessed using 10 items taken from the PAS questionnaire at baseline and one month after the end of the intervention

Secondary ID(s)

N/A

Source(s) of Monetary Support

Seventh Framework Programme