Evaluation of In:tuition - life-skills based interactive teaching resource for primary and secondary schools (study 1 10-and 11-year-old children)

ISRCTN	ISRCTN86224191
DOI	https://doi.org/10.1186/ISRCTN86224191
Secondary identifying numbers	NFER1

Submission date: 21/05/2013
Registration date: 29/07/2013
Last edited: 06/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
In:tuition is a life-skills education programme which aims to build young peoples 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 peoples 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

Contact information

Dr Ben Styles
Scientific

National Foundation for Educational Research
The Mere
Upton Park
Slough
SL1 2DQ
United Kingdom

Phone	+44 (0)1753 637386
Email	b.styles@nfer.ac.uk

Study information

Study design	Cluster randomised trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	ISRCTN86224191_PIS_06Feb17.docx
Scientific title	Cluster-randomised trial of a life-skills programme to manage peer pressure for 10- and 11-year-old children
Study 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(s)	National Foundation for Educational Research’s Code of Practice Committee, 09/05/2013
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
Primary outcome measure	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 study start date	25/10/2012
Overall study end date	09/03/2015

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	1750 students across 70 primary schools.
Participant inclusion criteria	Students in year 5 of primary school
Participant exclusion criteria	Parental opt-out
Recruitment start date	15/04/2013
Recruitment end date	16/07/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

National Foundation for Educational Research

The Mere
Upton Park
Slough
SL1 2DQ
United Kingdom

Sponsor information

Alcohol Research UK (UK)
Charity

4th Floor
17-23 Willow House
London
SW1P 1JH
United Kingdom

Phone	+44 (0)20 7821 7880
Email	jamesnicholls@alcoholresearchuk.org
Website	http://alcoholresearchuk.org/
"ROR"	https://ror.org/00dpq7q77

Funders

Funder type

Charity

Alcohol Research UK (UK)
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date	06/02/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Funder report results	results	01/03/2015		No	No
Participant information sheet		06/02/2017	06/02/2017	No	Yes

Additional files

ISRCTN86224191_PIS_06Feb17.docx: Uploaded 06/02/2017

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.

Evaluation of In:tuition - life-skills based interactive teaching resource for primary and secondary schools (study 1 10-and 11-year-old children)