Condition category
Mental and Behavioural Disorders
Date applied
09/03/2012
Date assigned
11/04/2012
Last edited
27/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Research indicates that children with Autism Spectrum Conditions (ASCs) can be taught to play via appropriate intervention, and that this may also improve their social communication skills. However, research in this area is currently lacking. We are interested in exploring whether the social interactions of preschool children with social communication difficulties can be enhanced by developing their play skills.

Who can participate?
Preschool children attending a Children's Centre preschool in Hampshire can attend. Children do not need to have a diagnosis of an ASC, but do need to have a funded special educational needs place at preschool relating to their social communication difficulties.

What does the study involve?
After consent is given, a researcher visits the child at their preschool setting to conduct some assessments. Children will then be randomly selected to either receive a short individual play intervention each day for two weeks at preschool, or to continue their preschool as usual for two weeks. The intervention, called Identiplay, lasts for 10 minutes each day and will be delivered by the child’s usual key worker. Identiplay teaches play and has been used with many preschool children with social communication needs across Hampshire. After these two weeks the researcher will visit the participant at preschool again and repeat the assessments. After a further six weeks this will be repeated.

What are the possible benefits and risks of taking part?
You would be helping us to understand the links between play and social communication skills in individuals with ASCs. There are no risks involved in taking part.

Where is the study run from?
University of Southampton (UK).

When is the study starting and how long is it expected to run for?
From September 2011 to March 2012.

Who is funding the study?
University of Southampton (UK).

Who is the main contact?
Miss Chloe Allen
cla1g09@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Chloe Allen

ORCID ID

Contact details

University of Southampton
University Road
Southampton
SO151BJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Can we enhance the social communication skills of preschool children with Autism Spectrum Conditions through play?

Acronym

Study hypothesis

Autism spectrum conditions (ASCs) include autistic disorder, pervasive developmental disorder (PDD), and Asperger's disorder, and are characterised by deficits in social interaction, communication, and imagination.

Hypothesis:
Exposure to an intervention aiming to enhance play skills will result in a significant increase in play skills, social play development and the frequency of social communication behaviours.

Ethics approval

Department of Psychology Ethics Committee, University of Southampton, 08/08/2011, ref: 704

Study design

Multicentre randomised controlled trial

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

Preschool children with Autism Spectrum Conditions

Intervention

Children will be matched into pairs and then randomly allocated to either the intervention or treatment as usual condition. The play intervention will take place daily at preschool with the child and their keyworker working one to one. The intervention used is known as Identiplay.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Preschool teacher-rated SDQ
2. Symbolic Play Test
3. 10-minute video recording of child engaged in free play with peers coded using the M-COSMIC, developmental and social level of play

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2011

Overall trial end date

19/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Attending a special educational needs funded place for children with social communication needs in a children's centre
2. Aged between 2 years 9 months and 5 years
3. Written parental consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Speech and language delay in the absence of social communication concerns
2. Major medical conditions impacting on the effects of the intervention

Recruitment start date

01/09/2011

Recruitment end date

19/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Southampton
SO151BJ
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

c/o Miss Chloe Allen
University of Southampton
University Road
Southampton
SO17 1BJ
United Kingdom

Sponsor type

University/education

Website

http://www.southampton.ac.uk/

Funders

Funder type

University/education

Funder name

University of Southampton (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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