- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03379818
Vocabulary Intervention for Late Talkers
Shape Bias Training as a Vocabulary Intervention for Late Talkers
Most studies regarding word learning have focused on understanding when and how infants learn words. At 24 months, typically developing infants know between 200 and 300 words and add new words to their vocabularies at a rapid rate. It is also during the first years of life that some principles that promote vocabulary learning are developed. The shape bias, which is a tendency to infer that objects that share the same shape will also share the same name, is the one that has been studied the most. At 24 months, typically developing infants use this principle as a strategy to learn novel words. In contrast, Late Talkers (children with a language delay in the absence of a physiological, cognitive or genetic disorder that may account for this delay) do not exhibit this preference. It has been found that teaching typically developing infants a shape bias prior to the end of the second year of life can boosts their word learning. Despite this, the possibility of teaching Late Talkers this principle and its effect on their vocabulary and language development has not been explored.
Over a series of 9 weekly sessions, Late Talkers (diagnosed by Language Therapists from the Birmingham Community Healthcare National Health Services Foundation Trust, United Kingdom) will be introduced to one of two possible interventions: a shape bias intervention and a more conventional intervention called "specific word intervention". Both interventions will be compared after 9 weeks. One year later, a follow up study will be conducted to assess the long-term effects each intervention has in word learning. Participants will be referred by a Speech and Language Therapists from the Birmingham Community Healthcare National Health Services Foundation Trust, United Kingdom, and all assessments and interventions will take place at the Infant and Child Lab at the University of Birmingham, United Kingdom.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objectives of the present study are:
A. To investigate whether it is possible to teach Late Talkers to attend to objects' shapes as a useful property for learning and generalizing novel object labels.
B. To assess the benefits that this intervention programme has on Late Talkers' short-term vocabulary development compared to an intervention where infants will be taught specific words ('specific word' intervention).
C. Assess whether the success of teaching Late Talkers a shape bias for noun extension is related to their sensitivity to object shape similarities.
D. Assess whether the success of teaching Late Talkers a shape bias for noun extension is related to their ability of sustain their attention to novel objects that are presented to them.
E. To assess the benefits of the intervention programme on language and cognitive development one year after the intervention compared to the 'specific word' intervention
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Birmingham
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Edgbaston, Birmingham, United Kingdom, B15 2TT
- Infant and Child Laboratory, University of Birmingham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children (boys and girls) between 24 and 48 months.
- Children from Birmingham (United Kingdom) and its surrounding areas.
- Monolingual English native speakers
- Children with a moderate or severe language delay, as diagnosed by a Speech and Language Therapist of the Birmingham Community Healthcare National Health Service Foundation Trust, United Kingdom.
Exclusion Criteria:
- Children with a developmental, physiological, neurological or cognitive disorder that could explain their language delay.
- Children with a mild language delay, as diagnosed by a Speech and Language Therapist of the Birmingham Community Healthcare National Health Service Foundation Trust, United Kingdom.
- Children that speak or know another language different than English, either as first or additional language.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Specific word training intervention
This training programme will be similar to a typical word learning intervention.
Infants will be introduced to 28 real objects and their names (e.g.
biscuit, trousers).
These objects will be divided into 7 sets of four words, and during each session, infants will be presented with one of this sets.
Each session will consist of a 15 min play session in which each object will be presented at least 10 times and each object name will be mentioned at least 10 times.
Additionally, techniques such as focused stimulation and modelling target words, which have proved to be useful for word learning, will be used.
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In this intervention, participants will be taught the names of 28 real objects.
The target words have been selected from the "Wordbank database", which is an open database that lists the proportion of children that know a specific word at a specific age.
Twenty-eight words that are understood by 80% of the total child population at 25 months were randomly selected as target words.
Techniques such as focused stimulation and modelling target words, which have proved to be useful for word learning, will be used.
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EXPERIMENTAL: Shape training intervention
In the shape training intervention, infants will be presented with four novel words paired with four novel sets of objects.
Each set consists of two exemplars with the same shape but with different colors and textures, and a contrasting object.
Each set will be presented in a play session, and the name of the objects will be mentioned at least 10 times.
The other three sets of exemplars will be presented in the same way.
Each session will last 15 minutes.
This intervention is based on a study conducted by Smith and colleagues (2002), where they found that typically developing infants that are taught to attend to shape at 17 months old, can enhance significantly their word learning.
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This intervention is based on on a study conducted by Smith and colleagues (2002), where they found that teaching typically developing infants to attend to shape by the end of the second year of life significantly enhances their word learning.
Participants will be taught that the significant property they should focus in when learning and extending novel labels is shape.
This will be done through play-like sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether children have learned a shape bias
Time Frame: This will be done at week 8 and 9 after starting the intervention.
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Will be assessed by means of a noun extension test with novel names and objects never heard and seen before by the infants at the end of the intervention programme.
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This will be done at week 8 and 9 after starting the intervention.
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Efficacy of each intervention programme
Time Frame: This will be done by assessing infants before (week 1) and after (week 9 ) the intervention programmes.
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In order to assess the benefits of each intervention programme in the infants' general vocabulary development, parents/guardians will fill in a vocabulary checklist filled in before and an intervention (for both types).
We will compare the vocabulary growth in the group of children that took part in the shape bias intervention programme with that of the group of children that took part in the 'specific word' intervention.
A significant larger increase in the shape bias intervention compared to the 'specific word' intervention will provide information regarding the success or efficacy of the shape bias intervention.
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This will be done by assessing infants before (week 1) and after (week 9 ) the intervention programmes.
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Long-term effects that each intervention has on language development.
Time Frame: This will be assessed one year after the end of the intervention programme.
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This will be assessed with a receptive language test.
The results will be compared to a standardized mean of the United Kingdom population and will be used to assess if the child caught up in their language development or not.
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This will be assessed one year after the end of the intervention programme.
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Long-term effects that each intervention has on visual spatial skills.
Time Frame: Visual spatial skills will be assessed one year after the end of the intervention programme.
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Each child will be assessed with a standardized test and their results will be used to know if there is an effect of each intervention programme in visual spatial skills.
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Visual spatial skills will be assessed one year after the end of the intervention programme.
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Long-term effects that each intervention has on working memory.
Time Frame: Working memory will be assessed one year after the end of the intervention programme.
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Each child will be assessed with a standard test and their results will be used to know if there is an effect of each intervention programme in working memory.
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Working memory will be assessed one year after the end of the intervention programme.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether children are more receptive to the shape bias intervention if they are sensitive to shape similarities.
Time Frame: Infants will be assessed in the first week of the intervention.
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Will be assessed by relating children's ability to sort objects by shape before the intervention and their ability to extend object labels by shape after the intervention.
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Infants will be assessed in the first week of the intervention.
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Whether children' are more receptive to the shape bias intervention if they can sustain their attention to novel objects,
Time Frame: Infants will be assessed with an attention task in the first week of the intervention.
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Will be assessed by relating children's sustained attention during the presentation of a video showing a person presenting and moving novel objects before the intervention, their attention to the novel objects during the intervention, and their ability to extend object labels by shape after the intervention.
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Infants will be assessed with an attention task in the first week of the intervention.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Andrea Krott, Dr, University of Birmingham
- Principal Investigator: Claudia Zuniga-Montanez, University of Birmingham
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG_17-142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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