Language DelayNCT03379818
Vocabulary Intervention for Late Talkers
A study testing Shape training intervention and Specific word training in people with Language Delay and Language Development Disorders, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 to 48 months
- Conditions the study is for
- Language Delay, Language Development Disorders
- What is being tested?
- Shape training intervention and Specific word training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jun 2018to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Infant and Child Laboratory, University of Birmingham
Edgbaston, Birmingham, B15 2TT
About this study
Official title: 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.
Read the detailed description
The objectives of the present study are:
- 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.
- 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).
- Assess whether the success of teaching Late Talkers a shape bias for noun extension is related to their sensitivity to object shape similarities.
- 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.
- To assess the benefits of the intervention programme on language and cognitive development one year after the intervention compared to the 'specific word' intervention
- Conditions
- Language Delay, Language Development Disorders
- Being tested
- Shape training intervention, Specific word training
- Keywords
- Shape bias, Late Talkers
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shape training interventionBehavioural
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.
Specific word trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Specific word training intervention | Experimental | 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. Receives: Behavioral: Specific word training |
| Shape training intervention | Experimental | 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. Receives: Behavioral: Shape training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Shape Choices in Two Noun Extension Tests.
Assessed using two noun extension tests with known and novel names and objects. The objective was to assess if participants would extend known or novel names to objects sharing the same shape. The test with known names was conducted in week 8. The test with novel names was conducted at week 9 after starting the intervention.
In each test, participants completed 8 trials. For each trial, participants were shown an object and heard its name. They were then asked to get another object that was also called the same from a set of 3 objects shown to them (one object shared the same shape, a second one shared the same colour and a third one shared the same texture). The same procedure was used on each trial but the objects and names used were different each time.
If participants learned a shape bias, they should have mainly chosen the objects that shared the same shape. Below we show the average percentage of shape choices in each group for both tests.
Measured: At week 8 after starting the interventions for known names and objects. At week 9 after starting the interventions for novel names and objects.
Assessment of Number of Words Known Before and After the Interventions.
In order to assess the benefits of each intervention programme, parents/guardians filled in a vocabulary checklist before (week 1) and after (week 9) the interventions. We compared the vocabulary growth (receptive and expressive vocabulary) 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.
Measured: Parents/guardians filled in a vocabulary checklist before (week 1) and after (week 9) the interventions.
Long-term Effects of Each Intervention on Language Development.
This was expected to be assessed with a language test. Due to closures related to the covid-19 pandemic, this assessment was not able to be conducted and the study was stopped.
Measured: Was expected to be assessed one year after the end of the intervention programme.
Long-term Effects of Each Intervention on Visual Spatial Skills.
Each child was expected to be assessed with a standardized visual spatial test. Due to closures related to the covid-19 pandemic, this assessment was not able to be conducted and the study was stopped.
Measured: Visual spatial skills assessed one year after the end of the intervention programme.
Long-term Effects of Each Intervention on Working Memory.
Each child was expected to be assessed with a memory test. Due to closures related to the covid-19 pandemic, this assessment was not able to be conducted.
Measured: Was expected to be assessed one year after the end of the intervention programme.
Secondary outcomes (2)
Children's Sensitivity Towards Shape Similarities.
Assessed by relating children's ability to sort objects by shape before the intervention.
Measured: Assessed in the first week of the intervention.
Children's Attention to Novel Objects.
Assessed by relating children's sustained attention during the presentation of a video showing a person presenting and moving novel objects before the intervention.
Note that two participants preferred not to complete this assessment, therefore they are not included in this analysis.
Measured: Assessed with an attention task in the first week of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start19 Jun 2018
- Primary completion13 Mar 2020
- Study completion30 Jul 2021
Why it stopped: Study was stopped due to closures related to the Covid-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Language DelayStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Over a series of 9 weekly sessions, children diagnosed as Late Talkers will be assessed in different tasks that can be divided into 5 phases: Vocabulary and developmental assessments, initial cognitive assessments, training sessions, word learning test 1, and word learning test 2. Each group (shape training group and specific word training group) will receive a different training programme, however the other assessments will be identical across the groups. In the shape training group, participants will be taught to attend to shape when learning and extending novel labels. In the specific word training group, participants will be taught specific words that they do not know. Before and after the intervention, participants vocabulary will be assessed to compare which intervention enhances word learning. One year later, all participants will be assessed with a language test and a cognitive test. The same assessments will be used in both groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Andrea Krott, University of Birmingham
- Investigators
- Andrea Krott, Dr, Study director, University of BirminghamClaudia Zuniga-Montanez, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379818
- Sponsor's protocol ID
- RG_17-142
- Status last verified
- May 2024
- First submitted
- 6 Dec 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shape Bias Training as a Vocabulary Intervention for Late Talkers
- ClinicalTrials.gov ID
- NCT03379818
- Acronym / sponsor ID
- RG_17-142
- Conditions
- Language Delay, Language Development Disorders
- Keywords
- Shape bias, Late Talkers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to closures related to the Covid-19 pandemic.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objectives of the present study are:
- 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.
- 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).
- Assess whether the success of teaching Late Talkers a shape bias for noun extension is related to their sensitivity to object shape similarities.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Over a series of 9 weekly sessions, children diagnosed as Late Talkers will be assessed in different tasks that can be divided into 5 phases: Vocabulary and developmental assessments, initial cognitive assessments, training sessions, word learning test 1, and word learning test 2. Each group (shape training group and specific word training group) will receive a different training programme, however the other assessments will be identical across the groups. In the shape training group, participants will be taught to attend to shape when learning and extending novel labels. In the specific word training group, participants will be taught specific words that they do not know. Before and after the intervention, participants vocabulary will be assessed to compare which intervention enhances word learning. One year later, all participants will be assessed with a language test and a cognitive test. The same assessments will be used in both groups.
| Arm | Type | Receives |
|---|---|---|
| Specific word training intervention | Experimental | Behavioral: Specific word trainingThis 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. |
| Shape training intervention | Experimental | Behavioral: Shape training interventionIn 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. |
Who may qualify
- Ages
- 24 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Shape training interventionThis 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. | Behavioural | Shape training intervention |
| Specific word trainingIn 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. | Behavioural | Specific word training intervention |
Primary outcome
Percentage of Shape Choices in Two Noun Extension Tests.
Time frame: At week 8 after starting the interventions for known names and objects. At week 9 after starting the interventions for novel names and objects.
Assessed using two noun extension tests with known and novel names and objects. The objective was to assess if participants would extend known or novel names to objects sharing the same shape. The test with known names was conducted in week 8. The test with novel names was conducted at week 9 after starting the intervention. In each test, participants completed 8 trials. For each trial, participants were shown an object and heard its name. They were then asked to get another object that was also called the same from a set of 3 objects shown to them (one object shared the same shape, a second one shared the same colour and a third one shared the same texture). The same procedure was used on each trial but the objects and names used were different each time. If participants learned a shape bias, they should have mainly chosen the objects that shared the same shape. Below we show the average percentage of shape choices in each group for both tests.
Assessment of Number of Words Known Before and After the Interventions.
Time frame: Parents/guardians filled in a vocabulary checklist before (week 1) and after (week 9) the interventions.
In order to assess the benefits of each intervention programme, parents/guardians filled in a vocabulary checklist before (week 1) and after (week 9) the interventions. We compared the vocabulary growth (receptive and expressive vocabulary) 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.
Long-term Effects of Each Intervention on Language Development.
Time frame: Was expected to be assessed one year after the end of the intervention programme.
This was expected to be assessed with a language test. Due to closures related to the covid-19 pandemic, this assessment was not able to be conducted and the study was stopped.
Long-term Effects of Each Intervention on Visual Spatial Skills.
Time frame: Visual spatial skills assessed one year after the end of the intervention programme.
Each child was expected to be assessed with a standardized visual spatial test. Due to closures related to the covid-19 pandemic, this assessment was not able to be conducted and the study was stopped.
Long-term Effects of Each Intervention on Working Memory.
Time frame: Was expected to be assessed one year after the end of the intervention programme.
Each child was expected to be assessed with a memory test. Due to closures related to the covid-19 pandemic, this assessment was not able to be conducted.
2 secondary outcomes
Children's Sensitivity Towards Shape Similarities.
Time frame: Assessed in the first week of the intervention.
Children's Attention to Novel Objects.
Time frame: Assessed with an attention task in the first week of the intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrea Krott, Dr study director
University of Birmingham
Claudia Zuniga-Montanez principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shape training intervention and Specific word training in people with Language Delay and Language Development Disorders, run by University of Birmingham 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Shape Choices in Two Noun Extension Tests. (time frame: At week 8 after starting the interventions for known names and objects. At week 9 after starting the interventions for novel names and objects.). The study lists 5 primary outcomes in all. 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 19 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.