Condition category
Mental and Behavioural Disorders
Date applied
21/05/2013
Date assigned
29/07/2013
Last edited
29/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In:tuition is a life-skills education programme which aims to build young people’s confidence, personal and social skills, helping them to explore how they make decisions so they can understand what might influence them. One of its ultimate aims is to reduce alcohol misuse but its focus is wider, addressing a range of relevant personal needs in an age-sensitive way.

Who can participate?
Students aged 11 and 12 years in year 7 of secondary school

What does the study involve?
In:tuition is being trialled in secondary schools. We ask year 7 children a series of questions in the summer term 2013. They are then randomly allocated either to receive In:tuition or their normal Personal, Social and Health Education provision during the autumn term 2013 and spring term 2014 i.e. when they are in year 8. In summer 2014, they are asked the same questions to determine whether In:tuition has worked.

What are the possible benefits and risks of participating?
The programme may improve young people’s confidence, personal and social skills.

Where is the study run from?
The study is being run by National Foundation for Educational Research, Slough, UK.

When is the study starting and how long is it expected to run for?
The study started in January 2013 and will run until September 2014.

Who is funding the study?
Alcohol Research UK

Who is the main contact?
Dr Ben Styles
b.styles@nfer.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ben Styles

ORCID ID

Contact details

National Foundation for Educational Research
The Mere
Upton Park
Slough
SL1 2DQ
United Kingdom
+44 (0)1753 637386
b.styles@nfer.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NFER2

Study information

Scientific title

Cluster randomised trial of life-skills programme to reduce alcohol misuse amongst 12- and 13-year-old children

Acronym

INTU2

Study hypothesis

The use of the In:tuition teaching resource reduces the frequency of drinking among 12- and 13-year-olds

Ethics approval

National Foundation for Educational Research Code of Practice Committee 9th May 2013.

Study design

Cluster randomised trial with baseline and follow-up questionnaires.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alcohol misuse

Intervention

In:tuition is a free life-skills based interactive teaching resource for primary and secondary schools developed by alcohol education charity Drinkaware.
Duration of intervention: 12 weeks of one lesson per week.
Participants are randomised into two groups:
1. The experimental group will consist of 2000 pupils across 40 schools who shall receive the In:tuition programme over 12 weeks; one lesson per week.
2. The control group will consist of 2000 pupils across 40 schools who shall receive their normal Personal, Social and Health education.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Frequency of drinking (once a month or more)
All outcomes are measured once at baseline (June 2013) and once a follow-up (May 2014)

Secondary outcome measures

1. Onset of drinking
2. Knowledge of health effects of alcohol
3. Resistance skills (confidence to manage peer pressure)
4. Decision-making skills
5. Understanding of social norms relating to alcohol

Overall trial start date

17/01/2013

Overall trial end date

30/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Students in year 7 of secondary school i.e. aged 11 and 12

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

4000 students across 80 secondary schools.

Participant exclusion criteria

Parental opt-out

Recruitment start date

17/01/2013

Recruitment end date

30/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Foundation for Educational Research
Slough
SL1 2DQ
United Kingdom

Sponsor information

Organisation

Alcohol Research UK (UK)

Sponsor details

4th Floor
17-23 Willow House
London
SW1P 1JH
United Kingdom
+44 (0)20 7821 7880
jamesnicholls@alcoholresearchuk.org

Sponsor type

Charity

Website

http://alcoholresearchuk.org/

Funders

Funder type

Charity

Funder name

Alcohol Research UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes