Condition category
Not Applicable
Date applied
15/02/2018
Date assigned
21/02/2018
Last edited
07/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The Sign 4 Programme uses sign language to support understanding and language development in hearing pre-school children. Nursery staff and parents read to children using Sign 4 story books and dolls to reinforce key words with sign language to facilitate story telling. Repeated use may help to improve children's comprehension, use of linking words, help with pronunciation and use of more complex words, as well as helping children to identify different emotions which allows them to 'name and tame' more challenging behaviours (such as 'frustrated' and 'angry'). The aim of this study is to find out whether the Sign 4 Programme improves language, speech and communication in pre-school children.

Who can participate?
Children aged under 5

What does the study involve?
Pre-school children take part in story time sessions in their nurseries as part of usual day-to-day activities. Children are assessed by nursery staff in four areas: listening and attention; understanding; speaking; and managing feelings and behaviour. These are part of standard assessments and are largely made through daily observation and activities. These assessments allow the tracking of progress over a period of months to assess the effectiveness of Sign 4 compared with a database of children who have not been part of the programme.

What are the possible benefits and risks of participating?
Early results suggest that children make better than expected progress in communication skills when attending Sign 4 story sessions. There are no anticipated risks.

Where is the study run from?
1. University of Bedfordshire (UK)
2. Flying Start Luton (UK)

When is the study starting and how long is it expected to run for?
February 2016 to November 2018

Who is funding the study?
1. University of Bedfordshire (UK)
2. Flying Start Luton (UK)

Who is the main contact?
Dr Rosemary Davidson
rosemary.davidson@beds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rosemary Davidson

ORCID ID

http://orcid.org/0000-0002-0010-4809

Contact details

Institute for Health Research
University of Bedfordshire
University Square
Luton
LU1 3JU
United Kingdom
+44 (0)796 667 6974
rosemary.davidson@beds.ac.uk

Type

Scientific

Additional contact

Prof Gurch Randhawa

ORCID ID

http://orcid.org/0000-0002-2289-5859

Contact details

Institute for Health Research
University of Bedfordshire
Putteridge Bury Campus
Hitchin Road
Luton
LU2 8LE
United Kingdom
-
gurch.randhawa@beds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FS_Sign4_LT_BF

Study information

Scientific title

Improving speech, language and communication in pre-school children: a process and outcome evaluation of the Sign 4 Programme, Luton, UK

Acronym

Sign 4 Little Talkers (S4LT) and Sign 4 Big Feelings (S4BF)

Study hypothesis

The Sign 4 Programme improves language, speech and communication in pre-school children when compared with a matched control group as measured by Early Years Outcomes (EYO).

Ethics approval

University Research Ethics Committee, University of Bedfordshire, 10/04/2017, ref: UREC104

Study design

Single-centre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

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

Condition

Development of speech, language and communication in pre-school children, with particular focus on children who are not showing expected levels of development

Intervention

Targeted intervention in early years settings versus statutorily collected Early Years Outcome (EYO) control data

The Sign 4 Programme uses British Sign Language to support understanding and language development in hearing children.

Approach 1: Designated Safeguarding Officers led, Luton wide
Approach 1 aims to implement Sign 4 Big Feelings across Luton to children assessed as having lower levels of expected development as efficiently as possible given limited resources. The intervention will be incorporated into existing safeguarding processes across the town in 50-60 schools, registered child minders, and private, voluntary or independent (PVI) nursery settings. Designated Safeguarding Officers (DSOs) will follow agreed protocols to identify and monitor a minimum of two children per setting who are below expected levels in communication and language development (and may show signs of emotional distress) as part of the evaluation, although many more children in each setting will use Sign 4. DSOs will attend a briefing session where they will learn about the intervention and receive the Sign 4 Big Feelings book and dolls. A ‘light touch’ ensures as great a reach as possible with early years professionals who already work with children judged to be at risk. Practitioners are asked to incorporate the story books and signing into daily routines with children, with data collected at baseline and follow-up at three months (one school term).

Approach 2: Targeted, 8 Early Years settings
Eight settings have been identified for a comprehensive roll out of the Sign 4 approach. These settings have reported lower than expected progress and attainment in communication and language as demonstrated by the Early Years Foundation Stage Outcomes data routinely collected and inputted into the Luton Borough Council Tracking System (LATS database). Children from these settings also do less well than Luton and National levels in Communication and Language and Managing Feelings and Behaviour when they are assessed using the EYFS Profile at aged 5. Head teachers and senior staff in each setting must be committed to implementing Sign 4 Little Talkers and be able to incorporate the intervention by embedding the approach into daily routines such as story time. All children in the specified age ranges appropriate for Sign 4 can access materials combining Little Talkers and Big Feelings materials, however, practitioners are led by stage of development of each child rather than chronological age. In addition, settings will identify approximately 10 children who need additional support and invite their families along for Sign 4 Little Talkers sessions so they can learn how to use the materials with their children. Practitioners are asked to incorporate the story books and signing into daily routines with children, with data collected at baseline and follow-up at six months (two school terms).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Listening and attention, speaking, managing feelings and behaviour, and understanding are measured using Early Years Outcomes at baseline and 6 month follow-up

Secondary outcome measures

Children’s well-being is measured using Leuven Well-being scales at baseline and 6 month follow-up

Overall trial start date

01/02/2016

Overall trial end date

01/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Children under 5 years
2. Early years practitioners
3. Head Teachers/Managers of pre-schools
4. Sign 4 Trainers
5. Sign 4 Managers
6. Local Authority commissioners

Participant type

Mixed

Age group

Child

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Persons with no experience of Sign 4
2. Persons with no experience of working in the early years sector

Recruitment start date

01/05/2017

Recruitment end date

01/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bedfordshire
Institute for Health Research University Square
Luton
LU1 3JU
United Kingdom

Trial participating centre

Flying Start Luton
The TOKKO Building 7 Gordon Street
Luton
LU1 2QP
United Kingdom

Sponsor information

Organisation

University of Bedfordshire

Sponsor details

Institute for Health Research
University Square
Luton
LU1 3JU
United Kingdom

Sponsor type

University/education

Website

https://www.beds.ac.uk/research-ref/ihr

Organisation

Flying Start Luton

Sponsor details

The TOKKO Building
7 Gordon Street
Luton
LU1 2QP
United Kingdom

Sponsor type

Government

Website

https://www.flyingstartluton.com

Funders

Funder type

University/education

Funder name

University of Bedfordshire

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Flying Start Luton

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study protocol is available on request and is to be submitted for publication. Participant information sheets and topic guides are available on request.

Two outcome articles and one process evaluation article. The outcome articles will report on data analysed from eight targeted settings and from childminders and Designated Safeguarding Officers. The process evaluation article will report on implementation and progress of the Sign 4 Programme.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

15/03/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/06/2018: Prof Gurch Randhawa has been added as a scientific contact