ClinicalTrials.gg
TerminatedNCT03379818Updated Sep 19, 2024Results posted

Vocabulary Intervention for Late Talkers

An interventional study of Shape training intervention and Specific word training in Language Delay and Language Development Disorders, sponsored by University of Birmingham. Terminated at 1 site in United Kingdom. Open to participants aged 24 Months to 48 Months. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University of Birmingham · Not applicable, Interventional, and Treatment

Why this study was terminated
Study was stopped due to closures related to the Covid-19 pandemic.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
24 Months to 48 Months
Sex
All
01

Study 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. 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:

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

02

Conditions studied

  • Language Delay
  • Language Development Disorders

Keywords

  • Shape bias
  • Late Talkers
03

In context

Language Development Disorders

121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.

This study's enrollment of 30 is below the median of 74 across 106 interventional studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Months to 48 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • 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.

    Behavioral: Specific word training

  • 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.

    Behavioral: Shape training intervention

Interventions

  • BehavioralShape training intervention

    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.

  • BehavioralSpecific word training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    Time frame: Parents/guardians filled in a vocabulary checklist before (week 1) and after (week 9) the interventions.

  3. 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.

    Time frame: Was expected to be assessed one year after the end of the intervention programme.

  4. 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.

    Time frame: Visual spatial skills assessed one year after the end of the intervention programme.

  5. 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.

    Time frame: Was expected to be assessed one year after the end of the intervention programme.

Secondary outcomes

  1. Children's Sensitivity Towards Shape Similarities.

    Assessed by relating children's ability to sort objects by shape before the intervention.

    Time frame: Assessed in the first week of the intervention.

  2. 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.

    Time frame: Assessed with an attention task in the first week of the intervention.

07

Results

Posted Sep 19, 2024
Limitations and caveats
The current project was stopped due to the Covid-19 pandemic. The follow-up was not able to be conducted due to closures, lockdowns and restrictions related to the Covid-19 pandemic. The number of participants was also smaller than planned due to the same reasons. Note that only a few participants were recruited through Birmingham Community Healthcare NHS Foundation Trust and others were recruited through community or social groups, or Language Through Play groups.

Participant flow

Participant flow — Overall Study
MilestoneSpecific Word Training InterventionShape Training Intervention
Started1214
Completed77
Not completed57
Withdrew: Closures due to the covid-19 pandemic22
Withdrew: Withdrawal by subject23
Withdrew: Diagnosis or suspected diagnosis of autism spectrum disorder (asd)12

Outcome measures

PrimaryPercentage 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.

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.
Reported as:
Mean · percentage of shape choices
Percentage of Shape Choices in Two Noun Extension Tests.
percentage of shape choicesSpecific Word Training InterventionShape Training Intervention
Known objects (week 8 after starting the intervention)37.50 ± 10.2056.63 ± 18.37
Novel objects (week 9 after starting the intervention)34.69 ± 18.9739.28 ± 13.36
PrimaryAssessment 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.

Time frame:
Parents/guardians filled in a vocabulary checklist before (week 1) and after (week 9) the interventions.
Reported as:
Mean · number of words
Assessment of Number of Words Known Before and After the Interventions.
number of wordsSpecific Word Training InterventionShape Training Intervention
Receptive (week 1 - vocabulary at the start of the study)207 ± 95.96288.43 ± 87.11
Receptive (week 9 - vocabulary at the end of the study)263.86 ± 107.19355.29 ± 106.81
Expressive (week 1 - vocabulary at the start of the study)62 ± 46.0476.86 ± 83.77
Expressive (week 9 - vocabulary at the end of the study)146.86 ± 109.90149.14 ± 151.35
PrimaryLong-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.

Time frame:
Was expected to be assessed one year after the end of the intervention programme.

No measurements were reported for this outcome.

PrimaryLong-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.

Time frame:
Visual spatial skills assessed one year after the end of the intervention programme.

No measurements were reported for this outcome.

PrimaryLong-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.

Time frame:
Was expected to be assessed one year after the end of the intervention programme.

No measurements were reported for this outcome.

SecondaryChildren's Sensitivity Towards Shape Similarities.

Assessed by relating children's ability to sort objects by shape before the intervention.

Time frame:
Assessed in the first week of the intervention.
Reported as:
Mean · percentage correctly sorted by shape
Children's Sensitivity Towards Shape Similarities.
percentage correctly sorted by shapeSpecific Word Training InterventionShape Training Intervention
Children's Sensitivity Towards Shape Similarities.41.66 ± 19.8342.85 ± 10.12
SecondaryChildren'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.

Time frame:
Assessed with an attention task in the first week of the intervention.
Reported as:
Mean · seconds
Children's Attention to Novel Objects.
secondsSpecific Word Training InterventionShape Training Intervention
Video 121.57 ± 10.7114.45 ± 12.46
Video 54.16 ± 10.204.38 ± 9.79

Adverse events

Collected over This study was a language intervention where children played with toys and were then assessed to see what they learned, therefore no adverse effects were expected/monitored.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Specific Word Training Intervention———
Shape Training Intervention———

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Specific Word Training InterventionShape Training InterventionTotal
Mean2.61 ± 0.422.76 ± 0.522.69 ± 0.47
Sex: Female, Male
Sex: Female, Male(Participants)Specific Word Training InterventionShape Training InterventionTotal
Female314
Male4610
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Specific Word Training InterventionShape Training InterventionTotal
Count of participants——0
Age of first words
Age of first words(months)Specific Word Training InterventionShape Training InterventionTotal
Mean22.16 ± 3.2521.25 ± 9.2121.8 ± 6.23
08

Study locations

1 site
  • Infant and Child Laboratory, University of Birmingham
    Edgbaston, Birmingham B15 2TT, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03379818
Collaborators
National Council of Science and Technology, Mexico
Responsible party
Andrea Krott (Dr, University of Birmingham) — Principal investigator
First posted
Dec 20, 2017
Start date
Jun 19, 2018
Primary completion
Mar 13, 2020
Completion
Jul 30, 2021
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Study contacts

Andrea Krott, Dr
study director · University of Birmingham
Claudia Zuniga-Montanez
principal investigator · University of Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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