NCT03379818

Brief 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.

Trial Health

57
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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

December 6, 2017

Results QC Date

November 7, 2022

Last Update Submit

May 7, 2024

Conditions

Keywords

Shape biasLate Talkers

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

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

Secondary Outcomes (2)

  • Children's Sensitivity Towards Shape Similarities.

    Assessed in the first week of the intervention.

  • Children's Attention to Novel Objects.

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

Study Arms (2)

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.

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.

Behavioral: Shape training intervention

Interventions

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.

Shape training intervention

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.

Specific word training intervention

Eligibility Criteria

Age24 Months - 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infant and Child Laboratory, University of Birmingham

Edgbaston, Birmingham, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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.

Results Point of Contact

Title
Dr Andrea Krott
Organization
University of Birmingham

Study Officials

  • Andrea Krott, Dr

    University of Birmingham

    STUDY DIRECTOR
  • Claudia Zuniga-Montanez

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomly assigned to one of two possible groups. In both groups, they will receive an intervention, however participants and their parents will not know which one. At the end of the study, participants and their parents will be informed about which group they were in and a document containing a detailed description of each intervention will be provided to them.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 20, 2017

Study Start

June 19, 2018

Primary Completion

March 13, 2020

Study Completion

July 30, 2021

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations