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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03315416
Other study ID # ICA-CDRF-2016-02-053
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date May 31, 2021

Study information

Verified date March 2020
Source Solent NHS Trust
Contact Samantha L Burr
Phone 07721 211 928
Email Sam.Burr@uwe.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will look at whether there is a relationship between how babies are fed, whether they suck a dummy/hand and how they develop speech.


Description:

Background:

In the UK every year around 48,000 children aged 2-5 years are referred to NHS Speech & Language Therapy (SLT) services with difficulties using the right sounds in their talking. This is known as speech sound disorders (SSD). This is the largest population seen by Speech and Language Therapists and costs the NHS about £24 million per year.

Children with SSD are more at risk of mental health problems and difficulties making relationships with those around them. They are also more likely to struggle with learning at school and be involved with the criminal justice system at some point in their early lives. When a baby is born parents make different choices about feeding their baby. Some breastfeed, some bottle-feed and some use a mixture of both. Some babies also like to have a dummy, while others suck their hand and some don't suck anything. Some studies have found that breastfeeding is linked to better language and learning in later childhood, while others have found that dummy sucking has the opposite effect.

However, the effect that different types of feeding have on speech development has not been looked at in as much detail.


Recruitment information / eligibility

Status Recruiting
Enrollment 135
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 24 Months to 66 Months
Eligibility Inclusion Criteria:

- Children aged 2;0-5;6 on current speech and language therapy clinical caseloads in Hampshire (Solent NHS Trust) who have a diagnosis of speech sound disorder.

Exclusion Criteria:

- Genetic Disorder (including Downs Syndrome and other identified syndromes) Other congenital anomaly (e.g Cerebral Palsy, Global Developmental Delay) Diagnosed Learning Disability Permanent Hearing Loss (Sensorineural) Cleft lip and/or palate and/or submucous cleft palate Premature birth (before 37 completed weeks gestation) English as second or additional language

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Speech Sound Assessment
Formal standardised speech sound assessment typically used as part of standard NHS care by Speech and language Therapists

Locations

Country Name City State
United Kingdom Solent NHS Trust Southampton

Sponsors (1)

Lead Sponsor Collaborator
Samanth Burr

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Consonants Correct (PCC) on a single word naming test. PCC is a speech sound articulation test used to measure the number of correct consonant sounds produced compared to the number of consonant sounds attempted. Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.
Secondary Presence of developmental and non-developmental error patterns in speech. There are a variety of sound changes (error patterns) that feature in typical speech sound development. There are also patterns that are characteristic of atypical speech sound development. The speech samples gained from using the Diagnostic Evaluation of Articulation and Phonology (DEAP) speech assessment will be analysed by a qualified Speech and Language Therapist to identify atypical speech errors. These will then be quantified for use in the statistical analysis. Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.
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