Condition category
Not Applicable
Date applied
21/05/2013
Date assigned
29/07/2013
Last edited
06/02/2017
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 in year 5 of primary school.

What does the study involve?
In:tuition is being trialled in primary schools. We ask year 5 children a series of questions in the summer term 2013. They are then randomly allocated either to receive either 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 6. 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 and takes place in 79 primary schools from across England (UK)

When is the study starting and how long is it expected to run for?
October 2012 to March 2015

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

NFER1

Study information

Scientific title

Cluster-randomised trial of a life-skills programme to manage peer pressure for 10- and 11-year-old children

Acronym

INTU1

Study hypothesis

The aim of this study is to evaluate whether the use of the In:tuition teaching resource improves confidence to manage peer pressure in 10 and 11 year-olds.

Ethics approval

National Foundation for Educational Research’s Code of Practice Committee, 09/05/2013

Study design

Cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

See additional files

Condition

Peer pressure management in children

Intervention

Interventions as of 06/02/2017:
Schools are randomly allocated to intervention and control. Schools were randomised in five blocks. Block sizes are 46, 12, 10, 10 and 1. Schools are aware of their group allocation when they completed the baseline questionnaires, as they are simultaneously notified of their group and asked to complete questionnaires.

Intervention arm: The primary school programme consists of 12 lessons (a period of 40 minutes is recommended for each lesson). Alcohol is its theme but the focus is much wider and also includes:
1. Self-awareness
2. Attitudes and behaviour
3. Advertising, branding and the media
4. Personal choices
5. Emotions, communication skills and assertive behaviour
6. The influence of peers
7. Toal setting and confidence.
In:tuition uses a ‘life skills approach’ to help pupils learn and practice some important skills such as communication, working as a team and decision-making. The programme can be delivered through Personal, Social, and Health Education (PSHE) and Citizenship teaching but schools can also adopt a cross-curricular approach. Some digital tools are included, but each lesson has a paper-based alternative available to download. Home learning tasks are included to encourage discussion with parents/carers and promote consistent messages to young people at home and school.

Control arm: Control schools continued with their normal PSHE/alcohol education curriculum.

Original interventions:
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.
The participants are randomised to two groups:
The experimental group will consist of 875 pupils across 35 schools who shall receive the In:tuition programme over 12 weeks; one lesson per week.
The control group will consist of 875 pupils across 35 schools who shall receive their normal Personal, Social and Health education.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Resistance skills (confidence to manage peer pressure)

All outcomes are measured using a bespoke questionnaire that consisted of new questions, questions from Fuller (2013) and questions from Lynch et al. (2013) at baseline and 12 months.

Secondary outcome measures

1. Knowledge of health effects of alcohol
2. Decision-making skills
3. Understanding of social norms relating to alcohol

All outcomes are measured using a bespoke questionnaire that consisted of new questions, questions from Fuller (2013) and questions from Lynch et al. (2013) at baseline and 12 months.

Overall trial start date

25/10/2012

Overall trial end date

09/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Students in year 5 of primary school

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1750 students across 70 primary schools.

Participant exclusion criteria

Parental opt-out

Recruitment start date

15/04/2013

Recruitment end date

16/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Foundation for Educational Research
The Mere Upton Park
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

Planned submission of another publication to the International Journal of Health Promotion and Education for publication.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are available upon request from Dr Ben Styles (b.styles@nfer.ac.uk)

Intention to publish date

06/02/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in http://alcoholresearchuk.org/downloads/finalReports/FinalReport_0123.pdf

Publication citations

Additional files

Editorial Notes

06/02/2017: The following changes have been made to the record: 1. Publication reference added 2. The overall trial dates have been updated from 17/01/2013 - 30/09/2014 to 25/10/2012 - 09/03/2015 and the recruitment dates have been updated from 17/01/2013 - 30/09/2014 to 15/04/2013 - 16/07/2013 3. The interventions section has been updated 4. The publication and dissemination plan and IPD Sharing plan have been added and the participant information sheet has been uploaded. 18/01/2017: No publications found in PubMed, verifying study status with principal investigator.