Condition category
Mental and Behavioural Disorders
Date applied
19/12/2016
Date assigned
10/01/2017
Last edited
10/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

http://www.scip2.bmh.manchester.ac.uk

Contact information

Type

Scientific

Primary contact

Dr Catherine Adams

ORCID ID

http://orcid.org/0000-0003-4413-0803

Contact details

School of Psychological Sciences (Ellen Wilkinson)
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 275 3368
catherine.adams@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33162

Study information

Scientific title

A new speech and language therapy intervention for children who have Social Communication Disorder: feasibility and acceptability to service users and practitioners

Acronym

Study hypothesis

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

North West - Liverpool Central Research Ethics Committee, 04/08/2016, ref: 16/NW/0500

Study design

Non-randomised; Both; Design type: Treatment, Psychological & Behavioural, Cross-sectional

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/07/2016

Overall trial end date

30/04/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 140; UK Sample Size: 140

Participant 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

Recruitment start date

12/01/2017

Recruitment end date

31/07/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Paediatric Speech and Language Therapy
Salford Royal Foundation Trust Sandringham House 3rd Floor Windsor Street
Salford
M5 4DG
United Kingdom

Trial participating centre

Children’s Speech and Language Therapy
Cumbria Partnership NHS Foundation Trust Springboard Child Development Centre Orton Road
Carlisle
CA2 7HE
United Kingdom

Trial participating centre

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

Sponsor information

Organisation

The University of Manchester

Sponsor details

Room 3.53 Simon Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 275 5436
fmhsethics@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes