Trial Outcomes & Findings for Vocabulary Intervention for Late Talkers (NCT NCT03379818)
NCT ID: NCT03379818
Last Updated: 2024-09-19
Results Overview
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.
TERMINATED
NA
30 participants
At week 8 after starting the interventions for known names and objects. At week 9 after starting the interventions for novel names and objects.
2024-09-19
Participant Flow
The number of participants recruited differs from the one described in the protocol as this study had to be stopped due to the covid-19 pandemic.
Participant milestones
| Measure |
Specific Word Training Intervention
This training programme was similar to a typical word learning intervention and was the control group. Children were 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, children were presented with one of these sets. Each session consisted of a 15 min play session in which each object was presented at least 10 times and each object name mentioned at least 10 times. Additionally, techniques such as focused stimulation and modelling target words, which have proved to be useful for word learning, were used.
|
Shape Training Intervention
In the shape training intervention, children were presented with four novel words paired with four novel sets of objects. Each set consisted of two exemplars with the same shape but with different colors and textures, and a contrasting object. Each set was presented in a play session, and the name of the objects were mentioned at least 10 times. The other three sets of exemplars were presented in the same way. Each session lasted 15 minutes. This intervention was 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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Specific Word Training Intervention
This training programme was similar to a typical word learning intervention and was the control group. Children were 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, children were presented with one of these sets. Each session consisted of a 15 min play session in which each object was presented at least 10 times and each object name mentioned at least 10 times. Additionally, techniques such as focused stimulation and modelling target words, which have proved to be useful for word learning, were used.
|
Shape Training Intervention
In the shape training intervention, children were presented with four novel words paired with four novel sets of objects. Each set consisted of two exemplars with the same shape but with different colors and textures, and a contrasting object. Each set was presented in a play session, and the name of the objects were mentioned at least 10 times. The other three sets of exemplars were presented in the same way. Each session lasted 15 minutes. This intervention was 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.
|
|---|---|---|
|
Overall Study
Closures due to the Covid-19 pandemic
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Diagnosis or suspected diagnosis of Autism spectrum disorder (ASD)
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Specific Word Training Intervention
n=7 Participants
This training programme was similar to a typical word learning intervention and was the control group. Children were 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, children were presented with one of these sets. Each session consisted of a 15 min play session in which each object was presented at least 10 times and each object name mentioned at least 10 times. Additionally, techniques such as focused stimulation and modelling target words, which have proved to be useful for word learning, were used.
|
Shape Training Intervention
n=7 Participants
In the shape training intervention, children were presented with four novel words paired with four novel sets of objects. Each set consisted of two exemplars with the same shape but with different colors and textures, and a contrasting object. Each set was presented in a play session, and the name of the objects were mentioned at least 10 times. The other three sets of exemplars were presented in the same way. Each session lasted 15 minutes. This intervention was 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.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.61 Years
STANDARD_DEVIATION 0.42 • n=7 Participants
|
2.76 Years
STANDARD_DEVIATION 0.52 • n=7 Participants
|
2.69 Years
STANDARD_DEVIATION 0.47 • n=14 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Age of first words
|
22.16 months
STANDARD_DEVIATION 3.25 • n=5 Participants • Two participants in each group were not yet using words to communicate at the beginning of the study as reported by parents.
|
21.25 months
STANDARD_DEVIATION 9.21 • n=5 Participants • Two participants in each group were not yet using words to communicate at the beginning of the study as reported by parents.
|
21.8 months
STANDARD_DEVIATION 6.23 • n=10 Participants • Two participants in each group were not yet using words to communicate at the beginning of the study as reported by parents.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Specific Word Training Intervention
n=7 Participants
This training programme was similar to a typical word learning intervention and was the control group. Children were 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, children were presented with one of these sets. Each session consisted of a 15 min play session in which each object was presented at least 10 times and each object name mentioned at least 10 times. Additionally, techniques such as focused stimulation and modelling target words, which have proved to be useful for word learning, were used.
|
Shape Training Intervention
n=7 Participants
In the shape training intervention, children were presented with four novel words paired with four novel sets of objects. Each set consisted of two exemplars with the same shape but with different colors and textures, and a contrasting object. Each set was presented in a play session, and the name of the objects were mentioned at least 10 times. The other three sets of exemplars were presented in the same way. Each session lasted 15 minutes. This intervention was 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.
|
|---|---|---|
|
Percentage of Shape Choices in Two Noun Extension Tests.
Known objects (week 8 after starting the intervention)
|
37.50 percentage of shape choices
Standard Deviation 10.20
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56.63 percentage of shape choices
Standard Deviation 18.37
|
|
Percentage of Shape Choices in Two Noun Extension Tests.
Novel objects (week 9 after starting the intervention)
|
34.69 percentage of shape choices
Standard Deviation 18.97
|
39.28 percentage of shape choices
Standard Deviation 13.36
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Specific Word Training Intervention
n=7 Participants
This training programme was similar to a typical word learning intervention and was the control group. Children were 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, children were presented with one of these sets. Each session consisted of a 15 min play session in which each object was presented at least 10 times and each object name mentioned at least 10 times. Additionally, techniques such as focused stimulation and modelling target words, which have proved to be useful for word learning, were used.
|
Shape Training Intervention
n=7 Participants
In the shape training intervention, children were presented with four novel words paired with four novel sets of objects. Each set consisted of two exemplars with the same shape but with different colors and textures, and a contrasting object. Each set was presented in a play session, and the name of the objects were mentioned at least 10 times. The other three sets of exemplars were presented in the same way. Each session lasted 15 minutes. This intervention was 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.
|
|---|---|---|
|
Assessment of Number of Words Known Before and After the Interventions.
Receptive (week 1 - vocabulary at the start of the study)
|
207 number of words
Standard Deviation 95.96
|
288.43 number of words
Standard Deviation 87.11
|
|
Assessment of Number of Words Known Before and After the Interventions.
Receptive (week 9 - vocabulary at the end of the study)
|
263.86 number of words
Standard Deviation 107.19
|
355.29 number of words
Standard Deviation 106.81
|
|
Assessment of Number of Words Known Before and After the Interventions.
Expressive (week 1 - vocabulary at the start of the study)
|
62 number of words
Standard Deviation 46.04
|
76.86 number of words
Standard Deviation 83.77
|
|
Assessment of Number of Words Known Before and After the Interventions.
Expressive (week 9 - vocabulary at the end of the study)
|
146.86 number of words
Standard Deviation 109.90
|
149.14 number of words
Standard Deviation 151.35
|
PRIMARY outcome
Timeframe: Was expected to be assessed one year after the end of the intervention programme.Population: Due to closures related to the covid-19 pandemic, this assessment was not able to be conducted and the study was stopped.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Visual spatial skills assessed one year after the end of the intervention programme.Population: Due to closures related to the covid-19 pandemic, this assessment was not able to be conducted and the study was stopped.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Was expected to be assessed one year after the end of the intervention programme.Population: Due to closures related to the covid-19 pandemic, this assessment was not able to be conducted.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed in the first week of the intervention.Assessed by relating children's ability to sort objects by shape before the intervention.
Outcome measures
| Measure |
Specific Word Training Intervention
n=7 Participants
This training programme was similar to a typical word learning intervention and was the control group. Children were 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, children were presented with one of these sets. Each session consisted of a 15 min play session in which each object was presented at least 10 times and each object name mentioned at least 10 times. Additionally, techniques such as focused stimulation and modelling target words, which have proved to be useful for word learning, were used.
|
Shape Training Intervention
n=7 Participants
In the shape training intervention, children were presented with four novel words paired with four novel sets of objects. Each set consisted of two exemplars with the same shape but with different colors and textures, and a contrasting object. Each set was presented in a play session, and the name of the objects were mentioned at least 10 times. The other three sets of exemplars were presented in the same way. Each session lasted 15 minutes. This intervention was 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.
|
|---|---|---|
|
Children's Sensitivity Towards Shape Similarities.
|
41.66 percentage correctly sorted by shape
Standard Deviation 19.83
|
42.85 percentage correctly sorted by shape
Standard Deviation 10.12
|
SECONDARY outcome
Timeframe: Assessed with an attention task in the first week of the intervention.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.
Outcome measures
| Measure |
Specific Word Training Intervention
n=7 Participants
This training programme was similar to a typical word learning intervention and was the control group. Children were 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, children were presented with one of these sets. Each session consisted of a 15 min play session in which each object was presented at least 10 times and each object name mentioned at least 10 times. Additionally, techniques such as focused stimulation and modelling target words, which have proved to be useful for word learning, were used.
|
Shape Training Intervention
n=5 Participants
In the shape training intervention, children were presented with four novel words paired with four novel sets of objects. Each set consisted of two exemplars with the same shape but with different colors and textures, and a contrasting object. Each set was presented in a play session, and the name of the objects were mentioned at least 10 times. The other three sets of exemplars were presented in the same way. Each session lasted 15 minutes. This intervention was 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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|---|---|---|
|
Children's Attention to Novel Objects.
Video 1
|
21.57 seconds
Standard Deviation 10.71
|
14.45 seconds
Standard Deviation 12.46
|
|
Children's Attention to Novel Objects.
Video 5
|
4.16 seconds
Standard Deviation 10.20
|
4.38 seconds
Standard Deviation 9.79
|
Adverse Events
Specific Word Training Intervention
Shape Training Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place