NCT03315416

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

3.6 years

First QC Date

October 9, 2017

Last Update Submit

March 16, 2020

Conditions

Keywords

Speech DisorderBreast FeedingInfant FeedingBottle FeedingSpeech DevelopmentSpeech Sound DevelopmentSpeech Sound DisorderNon-nutritive Sucking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Presence of developmental and non-developmental error patterns in speech.

    Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.

Study Arms (1)

NHS Sample

Children diagnosed with speech sound disorder aged 2-5 years

Other: Speech Sound Assessment

Interventions

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

Also known as: Diagnostic Evaluation of Articulation and Phonology (DEAP)
NHS Sample

Eligibility Criteria

Age24 Months - 66 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Solent NHS Trust

Southampton, SO19 8BR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Speech DisordersBreast FeedingBottle FeedingSpeech Sound Disorder

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehaviorNeurodevelopmental DisordersMental Disorders

Study Officials

  • Samantha L Burr

    Solent NHS Trust

    PRINCIPAL INVESTIGATOR
  • Toity Deave, Dr

    University of the West of England

    STUDY DIRECTOR

Central Study Contacts

Samantha L Burr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Academic Speech and Language Therapist

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 20, 2017

Study Start

November 1, 2017

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations