Speech-language therapy for child social communication disorder

ISRCTN	ISRCTN48030419
DOI	https://doi.org/10.1186/ISRCTN48030419
Secondary identifying numbers	33162

Submission date: 19/12/2016
Registration date: 10/01/2017
Last edited: 30/09/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Children who have social communication disorder (SCD) find it hard to understand and use language, especially in social situations. They may also show some mild features of autism (a condition that affects the way that a person communicates and relates to others). This can affect how well they learn at school, their friendships and emotional/mental health as they grow up. This has a substantial impact on families and is expensive for the NHS and social services. An effective communication intervention may be able to prevent some of these problems but there is currently no research to support this. Previously, the research group has developed a new speech and language therapy programme called the Social Communication Intervention Programme (SCIP) to children who have SCD in their schools. Parents and teachers felt that the intervention led to improvements in social communication. A bigger study with more children and NHS speech and language therapists (SLTs) is now needed to show if SCIP really does work. The aim of this study is to find out whether it would be feasible to conduct a large study looking at the effectiveness of SCIP.

Who can participate?
Children aged between six and ten who have social communication problems as observed by a speech and language therapist (SLT)

What does the study involve?
Children take part in the SCIP programme with a specially trained SLT. This involves working through a number of exercises from the SCIP manual over the course of 20 face to face sessions these sessions may take place over a period of 10 weeks or 20 weeks, dependent on need. At the start of the study and then after the programme has ended (at 10 or 20 weeks), children complete a range of assessments to see if their social communication problems have improved.

What are the possible benefits and risks of participating?
Participants may benefit from improvements to their social communication problems which could help them perform better in the classroom. There are no notable risks involved with participating.

Where is the study run from?
1. Paediatric Speech and Language Therapy, Salford Royal Foundation Trust (UK)
2. Paediatric Speech and Language Therapy, Cumbria Partnership NHS Foundation Trust (UK)
3. The University of Manchester (UK)

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

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Catherine Adams
catherine.adams@manchester.ac.uk

Study website

Contact information

Dr Catherine Adams
Scientific

School of Psychological Sciences (Ellen Wilkinson)
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0003-4413-0803
Phone	+44 161 275 3368
Email	catherine.adams@manchester.ac.uk

Study information

Study design	Non-randomised; Both; Design type: Treatment, Psychological & Behavioural, Cross-sectional
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A new speech and language therapy intervention for children who have Social Communication Disorder: feasibility and acceptability to service users and practitioners
Study objectives	The principal aim of this study is to assess the feasibility of conducting a substantive randomized controlled trial of a new speech and language therapy intervention (SCIP) for children who have Social Communication Disorder (SCD) in routine clinical practice.
Ethics approval(s)	North West - Liverpool Central Research Ethics Committee, 04/08/2016, ref: 16/NW/0500
Health condition(s) or problem(s) studied	Specialty: Children, Primary sub-specialty: General Paediatrics; UKCRC code/ Disease: Other/ General symptoms and signs
Intervention	All pariticpants take part in the Social Communication Intervention Programme, a manualised intervention for children with pragmatic language difficulties. The programme involves 20 sessions of individualised speech and language therapy delivered by a trained speech and language therapist. The sessions may be delivered over 10 weeks or 20 weeks. The intervention is manualised (The SCIP Manual Adams and Gaile, 2015) and individualised for each child according to her/his assessment results, needs and priorities as agreed with parents and teaching staff. Relevant intervention tasks are identified in three areas: Social Understanding and Social Interpretation, Pragmatics and Language Processing (high-level comprehension and expression). Therapeutic methods include modelling, role play, sabotage and sabotaged role play. Participants are followed up at the end of the intervention programme (at 10 or 20 weeks).
Intervention type	Other
Primary outcome measure	Goal attainment is measured using Goal Attainment Scaling to review individualised functional goals set at baseline, post-intervention (10 or 20 weeks)
Secondary outcome measures	1. Parent/carer reported pragmatic ability is measured using the Children's Communication Checklist -2 (CCC-2) at baseline and post-intervention (10 or 20 weeks) 2. Social language interpretation and peer verbal interactions are measured using the Social Language Development Test - Elementary at baseline and post-intervention (10 or 20 weeks) 3. Conversational ability is measured using Targeted Observation of Pragmatics in Children’s’ Conversation (TOPICC) at baseline and post-intervention (10 or 20 weeks) 4. Parent’s perception of changes in language skills, social interaction, social skills and peer interactions is measured using the Parent Functional Communication Checklist (PFCQ) at baseline and post-intervention (10 or 20 weeks) 5. Functional narrative skills are measured using a dynamic Narrative Measure at baseline and post-intervention (10 or 20 weeks) 6. Children’s perceptions of their own communication skills and of SCIP intervention are measured using Child Perception Measures post-intervention (10 or 20 weeks)
Overall study start date	01/07/2016
Completion date	30/04/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 140; UK Sample Size: 140
Key inclusion criteria	1. Age 6 -10 years 2. Parents/carers able to participate in intervention 3. Social communication problems as observed by the SLT - a minimum of two out of five behaviours from a brief social communication screening checklist 4. Non-verbal reasoning within normal limits (Percentile rank ≥ 5) as measured on the Ravens Coloured Progressive Matrices 5. Score in the communication impaired range (<58) on the Children’s Communication Checklist -2 General Communication Composite (CCC) and in the SCD range on the CCC- 2 Social Interaction Deviance Composite
Key exclusion criteria	1. Children unable to participate in intensive intervention as judged by speech and language therapist 2. Diagnosis of core autism according to Autism Diagnostic Observation Schedule ADOS-2 3. Significant hearing loss 4. Severe speech disorder 5. Severe physical disability
Date of first enrolment	12/01/2017
Date of final enrolment	31/07/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Paediatric Speech and Language Therapy

Salford Royal Foundation Trust
Sandringham House
3rd Floor
Windsor Street
Salford
M5 4DG
United Kingdom

Children’s Speech and Language Therapy

Cumbria Partnership NHS Foundation Trust
Springboard Child Development Centre
Orton Road
Carlisle
CA2 7HE
United Kingdom

The University of Manchester

School of Health Sciences (Ellen Wilkinson)
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor information

The University of Manchester
University/education

Room 3.53 Simon Building
Oxford Road
Manchester
M13 9PL
England
United Kingdom

Phone	+44 161 275 5436
Email	fmhsethics@manchester.ac.uk
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Study findings will be made available to parents and professionals taking part in the study. Findings will be published in peer-reviewed scientific journals, on the study website and presented at conferences. At a minimum the intent is for there to be one paper published in 2017 and two further papers in 2018.
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/09/2020	30/09/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

30/09/2020: Publication reference added.