Condition category
Mental and Behavioural Disorders
Date applied
05/11/2019
Date assigned
26/06/2020
Last edited
16/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The emergence of language is crucial for social and emotional development but it is estimated that up to 30% of individuals with autism fail to develop functional speech. Furthermore, once they reach school age, many autistic children with little or no language fail to make progress and rarely develop compensatory strategies, such as gesture, to communicate basic needs. This has a negative impact on individuals and their families and increases the risk of children developing emotional and behavioural problems. Currently, most intervention including speech and language therapy is provided in schools. Thus, parents are rarely involved in interventions such as The Picture Exchange Communication System (PECS) and cannot therefore develop these skills at home. PECS was specifically designed to help pre-verbal children with autism make spontaneous requests for basic needs i.e. food, play or leisure activities. Evidence for the effectiveness of PECS with children with autism is promising but limited. The aim of this study is to find out whether it is possible to recruit and deliver the PECS training to parents/carers and their children at home and to ask the families about the acceptability of this approach in order to design a much larger study that can test the benefit of the therapy.

Who can participate?
Children aged 2-10 with a clinical diagnosis of autism who are non/minimally verbal (i.e. fewer than 10 words used on a regular basis)

What does the study involve?
Participants are assessed at three timepoints: first when they are recruited to the study, then again at 20 weeks after they start and finally at 24 weeks after they start. Some assessments are only done at the start of the study i.e. a direct measure with the researcher to measure the child's development and questionnaires for the parents/carers about the child's autism symptoms and general development. Other assessments are done at all timepoints e.g. vocabulary development. Parents are also asked to use a phone App to note down the way in which their child makes requests and at the same time to use a mini-camera to record their child's communication. These measurements are taken for two brief periods (i.e. 1-2 hours) after school and at a weekend and are agreed with the parents. The researchers also ask families about their experience of participating in the study and about the types of local treatment they have received while participating in the study. Participants are randomly allocated either to:
1. Home-based PECS treatment (32 families). Families in this group receive the PECS treatment in addition to their local provision (education and health services)
2. Treatment as usual (32 families). TAU families continue to receive the local provision (education and health services) for their child.
Parents in both groups are invited to attend a short group session where they are informed about the study and the senior researchers can help with any problems relating to the use of the mobile phone App or mini-cameras. In addition, the parents in the TAU group have a session on communication and behaviour management strategies at home. The parents in the PECS group learn about the treatment which is a system for teaching children to communicate using pictures. It involves six stages, each focusing on specific communication skills and uses strategies to teach children to exchange a picture-card or object for an immediate high-value reward (e.g. favourite food).

What are the possible benefits and disadvantages and risks of taking part?
All children in this study will have assessments from a skilled professional and families will complete questionnaires that may help clarify the strengths and needs of their child. If requested the researchers can provide a brief written summary of the assessment data. All parents will be invited to attend a parent education day run by a senior researcher/clinician in the team to inform them about general strategies to improve communication and behavioural management in children with autism. The researchers do not anticipate that this study will result in any disadvantages or risks to families and PECS has not been found to have any unwanted effects in previous studies. For all families there is a time commitment required for the assessment visits. For families allocated to the PECS intervention, additional time is needed for therapy sessions and home practice. This may have effects on family life. The researchers will try to schedule sessions at times to suit each family, including outside normal working hours if necessary.

Where is the study run from?
Evelina Children's Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2019 to December 2021

Who is funding the study?
Autistica (UK)

Who is the main contact?
Dr Vicky Slonims
vicky.slonims@gstt.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vicky Slonims

ORCID ID

https://orcid.org/0000-0003-3339-2365

Contact details

Children's Neurosciences
2nd Floor Becket House
1 Lambeth Palace Road
London
SE1 7EU
United Kingdom
+44 (0)7896983982
vicky.slonims@gstt.nhs.uk

Type

Public

Additional contact

Mrs Viviana Aya

ORCID ID

Contact details

Children's Neurosciences
2nd Floor Becket House
1 Lambeth Palace Road
London
SE1 7EU
United Kingdom
+44 (0)7714391982
viviana.ayagomez@gstt.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Autistica Funder - ID: 7262 - Grant Reference: 7262

Study information

Scientific title

A pilot evaluation of a home-based Picture Exchange Communication Schedule (PECS) intervention for young non- or minimally-verbal children with autism

Acronym

HoPS

Study hypothesis

1. It is feasible and acceptable to teach the use of PECS to parents and their young autistic child at home.
2. It is feasible to use Early Years special school education services as a means to identify and recruit young children with autism in the London area.
3. A mobile App will be an acceptable and efficient method for parents to count and rate their child’s spontaneous requesting in the home context.
4. It is feasible and acceptable to use small body cameras (worn by the child) to gather direct observational data on spontaneous communication behaviour at home.
5. Pilot data, including retention rate, assessment completion and effect size, will be collected in order to prepare an application for a large multi-site RCT of home-based PECS training for parents of non-verbal young children with autism in the UK.
6. A short term follow-up, 4 weeks after the cessation of training can be conducted to monitor the continuing use of PECS at home and any sustained progress made by the child.

Ethics approval

Approved 25/09/2019, PNM Research Ethics Subcommittee, King's College London (Research Ethics Office, King's College London, 4/16 Franklin-Wilkins Building, (Waterloo Bridge Wing), Stamford Street, London, SE1 9NH, UK; Tel: +44 (0)20 7848 4077; Email: james.2.patterson@kcl.ac.uk), ref: HR-19/20-14197

Study design

Single-centre feasibility and pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

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

Condition

Autism

Intervention

Blocks of 6-8 parents at each school will be randomised to receive the PECS intervention or Treatment as Usual (TAU). A freely available random number allocation website will be used e.g. Random Allocation Software (RAS) or Research Randomiser. The research assistant will be blind to group allocation. Children will be stratified into two age groups (+/- 4 years) to avoid large differences between PECS and TAU groups. Eligibility criteria should mean that differences in language ability and autism severity are unlikely. Any possible differences in cognitive or other abilities will be explored in analysis. Qualitative data will be used to assess the acceptability of the study to families and to the therapist.

The delivery of the Picture Exchange Communication System (PECS) will be tested. PECS is a well-established manualised system for teaching children to communicate using pictures or objects. It involves 6 developmental stages, each focusing on specific communication skills. PECS uses behavioural strategies to teach children to exchange a picture-card or object for an immediate high-value reward (e.g. favourite food). Initially, teaching is primarily through the use of physical prompts, which are subsequently systematically faded to ensure independence.
Stage 1: focuses on teaching the child to exchange an image to receive a highly desirable item (often food). Prompts are given by a second adult and prompting is then gradually reduced.
Stage 2: develops a child’s persistence by creating small barriers to communication such as increasing the distance between the child and the desired object/activity.
Stage 3: more images of desired items are introduced and the child begins to discriminate between them to make requests.
Stage 4: combines images in a “picture strip” to indicate messages such as ‘I want….’, thereby helping the child to use more complex constructions.
Stages 5 and 6: build on these skills to help a child learn to answer questions (e.g. what do you want?) and to make comments (e.g. what can you see?)
The therapist will provide 6 weekly sessions at home with the parent and child, followed by a further 6 home-based sessions for the parent only on a fortnightly basis, giving a total of 12 sessions over 18 weeks. Home-based sessions and assessments will be arranged to fit in with parents’ commitments.

Parents in each group will be invited to attend a brief group workshop hosted by the school and delivered by the research leads. Parents in the TAU group will be provided with psycho-educational information about autism, and given strategies to support communication and behaviour management. The parents in the PECS group will be introduced to the intervention. Both groups will be given general information about how the study is to be conducted and have the opportunity to discuss the use of the App and the mini camera.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Successful recruitment of 64 eligible participants, measured using evaluation of participant numbers in each school (anticipated to be 4- 5 schools).
2. Successful data collection on questionnaire and direct assessments at relevant time points e.g. measurement of complete data sets for all recruited participants at each assessment point: baseline, end point (18 weeks) and follow up (22 weeks) and assessment of complete data sets for all recruited participants at the end of data collection for the study.
2.1. Autism symptoms: The Social Communication Questionnaire - Lifetime version
2.2. Communication: Communication Development Inventory (CDI) Words and Gestures
2.3. Adaptive Behaviour: The Adaptive Behaviour Assessment System (ABAS)
2.4. Developmental level: Researcher administered Mullen Scales of Development
2.5. Qualitative data e.g. A therapist rating (5 point scale), A parent-completed Social Validity Questionnaire
2.6. Local service use data: from parent completed Child and Adolescent Service Use Schedule (CA-SUS)
3. Acceptability of App and body-worn cameras and quality of data obtained from this equipment, measured using verbal feedback from parents at each assessment i.e. baseline, end point(18 weeks) and follow up (22 weeks).
4. Number of families retained in both groups, measured using assessment of the number of participating/engaged families at end point (18 weeks) and follow up assessments (22 weeks)
5. Number of home-based sessions delivered by the therapist, measured using therapist diary records at end of each family’s treatment (17-18 weeks)
6. Data (from the research therapist) on parent/child progression of PECS stages (i.e. 1-6) for treatment families (parent treatment fidelity) at end of treatment period (17-18 weeks)
7. Feedback on feasibility and acceptability of the intervention at treatment end point (18 weeks) from Parents assessed by Social Validity Questionnaire (for treatment group only). Two families randomly selected from each school (one treatment and one Treatment as Usual family) will have a qualitative interview with Dr Penny Williams on their experience of participating in the study. Focus groups to provide feedback on the experience of participating in the study will be arranged within 2 months of completion of the study for teachers in each school. At the end of the study the research assistant and therapist will be asked to provide feedback on their experience of participating in the study.

Secondary outcome measures

1. At baseline, end point (18 weeks) and follow up (22 weeks) PECS usage (count of requesting behaviours rated by parents via telephone App and by researcher from video), according to 2 codes: 1) use of PECS, 2) other forms of request. Other behaviours (anticipated to be non-communicative behaviour) will be noted.
2. Children’s communication assessed by parent-rated Communication Development Inventory (CDI) at baseline and end point (18 weeks)

Overall trial start date

01/04/2019

Overall trial end date

10/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Children:
1. Aged 2-10 years
2. Clinical diagnosis of autism, meeting cut-off for autism symptoms i.e ≥15 on the Social Communication Questionnaire
3. Non/minimally verbal (i.e. fewer than 10 words used on a regular basis)
Parents:
4. Willing to consent to participation and able to engage in intervention at home

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

64 in total: 32 in PECS treatment and 32 in treatment as usual group

Participant exclusion criteria

Children who have:
1. More than 10 words used regularly
2. Severe visual or hearing impairment
3. A twin brother or sister who would also be a candidate for the intervention
4. Parents in whom poor use and/or understanding of English would limit participation

Recruitment start date

30/09/2019

Recruitment end date

31/07/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Evelina Children's Hospital (Guy's & St Thomas' NHS Foundation Trust)
Children's Neurosciences 2nd Floor Becket House 1 Lambeth Palace Road
London
SE1 7EU
United Kingdom

Trial participating centre

Russet House School
11 Autumn Cl
Enfield
EN1 4JA
United Kingdom

Trial participating centre

Phoenix School
49 Bow Rd, Bow
London
E3 2AD
United Kingdom

Trial participating centre

Queensmill School
1 Askham Road Shepherds Bush
London
W12 0NW
United Kingdom

Sponsor information

Organisation

Evelina Children's Hospital, Guy's and St Thomas' NHS Foundation Trust and King's College London

Sponsor details

Children's Neurosciences
2nd Floor Becket House
1 Lambeth Palace Road
London
SE1 7EU
United Kingdom
+44 (0)7896983982
vicky.slonims@gstt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.evelinalondon.nhs.uk/Home.aspx

Funders

Funder type

Charity

Funder name

Autistica

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

The study protocol and pilot results will be published in peer-reviewed journals of general and special interest. The study will also be disseminated in collaboration with Ian Dale and Denise May at the National Autistic Society (NAS). The focus will be on three stakeholder audiences: (1) health practitioners, education professionals and researchers, (2) autistic people and their families, and (3) study participants. We aim to ensure that all three groups are fully informed about the project.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Vicky Slonims (Vicky.slonims@gstt.nhs.uk). Data are primarily qualitative relating to the feasibility of the study. Secondary data comprises information from questionnaires, a baseline direct assessment of child development and count ratings from video footage of children’s behaviour at home. The data can be applied for up to 3 years following the end of the study in accordance with KCL data storage policy. In addition, the ethics committee have indicated that they may wish to audit the progress of the study. In accordance with the participant information and consent forms the researchers will not share any data without first obtaining the permission of study participants. All data are kept in accordance with KCL ethics requirements, i.e. stored anonymously with personal data and study identification information kept separately; databases are password protected and stored on an NHS electronic file system with limited access (only named study personnel have access to the folder).

Intention to publish date

01/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/06/2020: Trial's existence confirmed by PNM Research Ethics Subcommittee, King's College London.