Speech Disorders in ChildrenNCT03315416
Infant Feeding, Non-nutritive Sucking and Speech Development
An observational study of Speech Disorders in Children, run by Samanth Burr at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 24 to 66 months
- Conditions the study is for
- Speech Disorders in Children
- What is being tested?
- Speech Sound Assessment
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2017to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 66 months
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Solent NHS Trust
Southampton, SO19 8BR
Samantha L Burr, MSc, 07721 211 928, Sam.Burr@uwe.ac.uk
Samantha L Burr, MSc
About this study
Official title: The Effect of Different Feeding Methods and Non-nutritive Sucking Behaviours on Child Speech Development
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.
Read the detailed 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.
- Conditions
- Speech Disorders in Children
- Being tested
- Speech Sound Assessment
- Keywords
- Speech Disorder, Breast Feeding, Infant Feeding, Bottle Feeding, Speech Development, Speech Sound Development, Speech Sound Disorder, Non-nutritive Sucking
- Medical subject headings
- Speech Disorders, Breast Feeding, Bottle Feeding, Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Sound AssessmentOther
Also called Diagnostic Evaluation of Articulation and Phonology (DEAP)
Formal standardised speech sound assessment typically used as part of standard NHS care by Speech and language Therapists
| Study group | Role | What they receive |
|---|---|---|
| NHS Sample | Children diagnosed with speech sound disorder aged 2-5 years Receives: Other: Speech Sound Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.
Secondary outcomes (1)
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.
Measured: Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Nov 2017
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech Disorders in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samanth Burr
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Samanth Burr, Solent NHS Trust
- Investigators
- Samantha L Burr, Principal investigator, Solent NHS TrustToity Deave, Dr, Study director, University of the West of England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315416
- Sponsor's protocol ID
- ICA-CDRF-2016-02-053
- Status last verified
- Mar 2020
- First submitted
- 9 Oct 2017
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Feeding Methods and Non-nutritive Sucking Behaviours on Child Speech Development
- ClinicalTrials.gov ID
- NCT03315416
- Acronym / sponsor ID
- ICA-CDRF-2016-02-053
- Conditions
- Speech Disorders in Children
- Keywords
- Speech Disorder, Breast Feeding, Infant Feeding, Bottle Feeding, Speech Development, Speech Sound Development, Speech Sound Disorder, Non-nutritive Sucking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Samanth BurrOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NHS Sample | – | Other: Speech Sound AssessmentChildren diagnosed with speech sound disorder aged 2-5 years |
Who may qualify
- Ages
- 24 to 66 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech Sound AssessmentAlso: Diagnostic Evaluation of Articulation and Phonology (DEAP)Formal standardised speech sound assessment typically used as part of standard NHS care by Speech and language Therapists | Other | NHS Sample |
Primary outcome
Percentage of Consonants Correct (PCC) on a single word naming test.
Time frame: Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.
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.
1 secondary outcome
Presence of developmental and non-developmental error patterns in speech.
Time frame: Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha L Burr principal investigator
Solent NHS Trust
Toity Deave, Dr study director
University of the West of England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Speech Disorders in Children, run by Samanth Burr at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha L Burr (07721 211 928, Sam.Burr@uwe.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Consonants Correct (PCC) on a single word naming test. (time frame: Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.