Condition category
Mental and Behavioural Disorders
Date applied
21/10/2016
Date assigned
26/10/2016
Last edited
24/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Speech, Language and Communication difficulties (SLCD) are common in childhood. They pose a major challenge to society, affecting educational attainment and the social and emotional health of over one million children and young adults in the UK. The most common type of SLCD is a speech sound disorder (SSD), in which children’s speech is difficult to understand. Traditionally, treatment programs for SSDs relied heavily on listening skills, in that patients listen to themselves speaking and change the way that they speak using what they hear. This is difficult for children for with weak listening skills and teaching children to speak clearly is problematic because the target pronunciations are difficult to see or describe. This project will use ultrasound to create images of the tongue in realtime, providing children and their Speech and Language Therapists with visual feedback that can be used to help in the treatment of previously intractable speech sound disorders. The aim of this study is to find out whether using ultrasound can be an effective way of improving treatment outcomes in children with SSD.

Who can participate?
Children aged 6 to 15 who have SSD.

What does the study involve?
Each child who takes part in the project visits the university centre for a course of ultrasound-based speech therapy designed specifically to improve their speech. Children are invited to attend three assessment sessions before they begin the therapy to check that they are suitable for the project. During these assessments, children are asked to say some words and read some sentences whilst their tongue movements are recorded using ultrasound via a special headset. Each child then receives 10 speech therapy sessions where they use the real-time images of their own tongue moving to help them learn how to improve their speech. The treatment varies from child to child as the Speech and Language Therapist designs individual therapy programs tailored to their specific needs. After the therapy and again three months later, each child's speech is recorded again with the ultrasound to check whether or not their speech has improved.

What are the possible benefits and risks of participating?
Children who take part will benefit from having an in-depth speech and language assessment and a course of speech therapy which may help them with their speech disorder. There are no notable risks involved with participating, although some children may experience some mild discomfort from wearing the ultrasound headset as it can start to feel heavy after around 30 minutes.

Where is the study run from?
Clinical Audiology Speech & Language Research Centre, Queen Margaret University (UK)

When is the study starting and how long is it expected to run for?
May 2015 to March 2017

Who is funding the study?
Chief Scientist Office (UK)

Who is the main contact?
Dr Joanne Cleland

Trial website

http://www.qmu.ac.uk/casl/ultraphonix/default.htm

Contact information

Type

Public

Primary contact

Dr Joanne Cleland

ORCID ID

http://orcid.org/0000-0002-0660-1646

Contact details

Psychological Sciences and Health
University of Strathclyde
Glasgow
G1 1QE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2.0

Study information

Scientific title

Ultrasound visual biofeedback treatment for speech sound disorders in children

Acronym

Study hypothesis

Research questions:
1. Does a course of ultrasound visual biofeedback treatment improve accuracy of the targeted speech sounds(s) in:
1.1. Words and phrases trained during the therapy (treated word lists)?
1.2. Words and phrases not trained during the therapy (untreated wordlists)
2. Does a course of Ultrasound Visual Biofeedback (UVBF) treatment improve intelligibility outside of the clinic environment?

Hypotheses:
1. Posttherapy, both treated words and untreated words have increased in accuracy relative to baseline recording
2. Posttherapy scores on the Intelligibility in Context Scale will have improved

Ethics approval

South East Scotland REC 01 (NHS Ethics), 30/03/2015, ref: 15/SS/0037

Study design

Single-centre non-randomised study

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

Developmental speech sound disorders in children

Intervention

Ultrasound Visual Biofeedback Therapy to treat speech sound disorders. This treatment uses standard medical ultrasound to image the tongue and uses this as a a biofeeback tool for motor-based speech therapy.

20 Children will be recruited to the project and each child will undergo assessment and therapy with ultrasound.

The study will use a standard medical ultrasound machine in tandem with a computer to record acoustics (speech) and articulation (tongue movement and lip moment from a camera) simultaneously. The ultrasound technique used is not physically invasive. For this particular study, children will sit next to an ultrasound scanner in a soundproofed studio. They will need to a stabilising headset, which will ensure that the ultrasound probe does not move too much once it is correctly positioned. The children will be asked to read words, name pictures or imitate spoken words from a computer. They may be asked to drink a few sips of water during the recording, this will gives us a fuller image of the inside of the mouth. They may also be recorded during unscripted spontaneous conversation.

In order to evaluate the effectiveness of ultrasound as a speech therapy tool, a qualified Speech & Language Therapist will design individual therapy plans for children using ultrasound. A single subjects design with multiple baselines (x3), midtherapy, posttherapy and maintenance phases will be used. Children will receive 10 weekly sessions of ultrasound at the speech clinic at Queen Margaret University. Each session will last approximately one hour.

Week 1: Baseline
Week 2: Baseline
Week 3: Baseline
Weeks 4 to 13: 10 sessions of therapy
Week 14: Maintenance Recording
Week 26: Follow up Maintenance Recording

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Intelligibility is measured using the Intelligibility in Context Scale at each of the three baselines, immediately post-intervention and at 3 months post-intervention.

Secondary outcome measures

Accuracy of speech production is measured using probe word lists and the Diagnostic Evaluation of Articulation and Phonology at each of the three baselines, immediately post-intervention and at 3 months post-intervention.

Overall trial start date

14/05/2015

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 6 to 15 years
2. Diagnosed with a Speech Sound Disorder involving difficulty with lingual articulations

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. No spoken English (at home OR at school)
2. Evidence of severe/profound current hearing loss
3. Major physical disability or structural abnormality of the vocal tract

Recruitment start date

01/06/2015

Recruitment end date

01/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Margaret University
Clinical Audiology Speech & Language Research Centre Queen Margaret University Drive
Musselburgh
EH21 6UU
United Kingdom

Sponsor information

Organisation

Queen Margaret University

Sponsor details

Queen Margaret University Drive
Musselburgh
EH21 6UU
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Chief Scientist Office

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication is a high-impact peer-reviewed journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor James Scobbie (jscobbie@qmu.ac.uk)

Intention to publish date

01/05/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes