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Vocabulary Intervention for Late Talkers

Primary Purpose

Language Delay, Language Development Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Shape training intervention
Specific word training
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Language Delay focused on measuring Shape bias, Late Talkers

Eligibility Criteria

24 Months - 48 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Infant and Child Laboratory, University of Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Specific word training intervention

Shape training intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Whether children have learned a shape bias
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.
Efficacy of each intervention programme
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.
Long-term effects that each intervention has on language development.
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.
Long-term effects that each intervention has on visual spatial skills.
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.
Long-term effects that each intervention has on working memory.
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.

Secondary Outcome Measures

Whether children are more receptive to the shape bias intervention if they are sensitive to shape similarities.
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.
Whether children' are more receptive to the shape bias intervention if they can sustain their attention to novel objects,
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.

Full Information

First Posted
December 6, 2017
Last Updated
May 5, 2021
Sponsor
University of Birmingham
Collaborators
National Council of Science and Technology, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03379818
Brief Title
Vocabulary Intervention for Late Talkers
Official Title
Shape Bias Training as a Vocabulary Intervention for Late Talkers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Birmingham
Collaborators
National Council of Science and Technology, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Delay, Language Development Disorders
Keywords
Shape bias, Late Talkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Participants will be randomly assigned to one of two posible 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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Specific word training intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Shape training intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Shape training intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Specific word training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Whether children have learned a shape bias
Description
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.
Time Frame
This will be done at week 8 and 9 after starting the intervention.
Title
Efficacy of each intervention programme
Description
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.
Time Frame
This will be done by assessing infants before (week 1) and after (week 9 ) the intervention programmes.
Title
Long-term effects that each intervention has on language development.
Description
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.
Time Frame
This will be assessed one year after the end of the intervention programme.
Title
Long-term effects that each intervention has on visual spatial skills.
Description
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.
Time Frame
Visual spatial skills will be assessed one year after the end of the intervention programme.
Title
Long-term effects that each intervention has on working memory.
Description
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.
Time Frame
Working memory will be assessed one year after the end of the intervention programme.
Secondary Outcome Measure Information:
Title
Whether children are more receptive to the shape bias intervention if they are sensitive to shape similarities.
Description
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.
Time Frame
Infants will be assessed in the first week of the intervention.
Title
Whether children' are more receptive to the shape bias intervention if they can sustain their attention to novel objects,
Description
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.
Time Frame
Infants will be assessed with an attention task in the first week of the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Krott, Dr
Organizational Affiliation
University of Birmingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Claudia Zuniga-Montanez
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infant and Child Laboratory, University of Birmingham
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Vocabulary Intervention for Late Talkers

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