Language DevelopmentNCT02854462
Supporting Children's School Readiness.
A study testing Language comprehension intervention and Counting intervention in people with Language Development, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
The aim of this project is to test whether training parents to ask their children 'inference- eliciting' questions during book reading is effective in promoting story comprehension for 4-year-olds from a range of socio-economic backgrounds. Read more about this study
- Who is it for?
- Ages 50 to 56 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Development
- What is being tested?
- Language comprehension intervention and Counting intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Aug 2016to 22 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 56 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children are:
- First born Full term (i.e. born no more than 3 weeks prematurely) With birth weight over 2.5 kg Being raised as monolingual English speakers
Who cannot join
- Neither caregivers nor infants have any significant known physical, mental or learning disability.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Sheffield
Sheffield, South Yorkshire, S10 2TN
About this study
Official title: A Randomised Control Trial to Test the Effect of Parents' Inference-eliciting Questions During Shared Book Reading on 4-year-olds' Listening Comprehension
The aim of this project is to test whether training parents to ask their children 'inference- eliciting' questions during book reading is effective in promoting story comprehension for 4-year-olds from a range of socio-economic backgrounds.
Read the detailed description
Language comprehension relies on the ability to make local and global inferences (e.g., inferring what a pronoun refers to, or inferring why a protagonist in a story did something based on information distributed through the text). These skills develop in the preschool years and are demonstrated when children make sense of stories that are read to them. While important for later reading ability and academic success, relatively little is known about whether anything can be done to improve inference-making skills in the preschool years. One possibility is that parent-child book reading would help. During book reading, some parents naturally ask their children questions about the story that would require them to make inferences about the text. The current study is designed to test whether doing this promotes children's ability to make inferences. Half the parents in this study will be given books with inference eliciting questions added to them and will be provided with training about how to ask these questions and respond to their children's answers. The other half of the parents will be given a maths exercise book and asked to spend the same amount of time per day working through this.
- Conditions
- Language Development
- Being tested
- Language comprehension intervention, Counting intervention
- Keywords
- Language Development, Shared Picture Book reading, Preschoolers, Inference making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language comprehension interventionBehavioural
Counting interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Language comprehension intervention | Experimental | The intervention will run for 4 weeks. Caregivers will be provided with storybooks (e.g., Percy the Park Keeper) that have been amended to include inference-eliciting questions. Caregivers will be trained (with a video) to ask these questions and respond to their children's answers during shared reading sessions. They will be asked to read one book per day. Caregivers will keep a reading diary. Receives: Behavioral: Language comprehension intervention |
| Counting intervention | Active comparator | The intervention will run for 4 weeks. Caregivers will be provided with a book 'At home with counting' that is made up of age appropriate maths exercises. Caregivers will trained (with a video) to work through one page of the book per day. This should take the same amount of time as the activity in the language intervention condition. Caregivers will keep a counting diary. Receives: Behavioral: Counting intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change after 4 weeks in children's ability to answer inference questions.
An age-appropriate test of inferencing ability has been developed for this study including vignettes developed by the Language and Reading Research Consortium. Children listen to short vignettes and are then asked questions that require them to make local and global inferences based on the information in the stories.
Measured: Baseline: when child is 4 years 3 months. Post test: 4 weeks post intervention
Secondary outcomes (1)
Change in NFER baseline assessment
This is an age appropriate test of maths and language ability.
Measured: Baseline: when child is 4 years 3 months - 4 years 6 months. Post test: 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start10 Aug 2016
- Primary completion20 Mar 2018
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DevelopmentStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Principal investigator, Danielle Matthews, University of Sheffield
- Investigators
- Danielle E Matthews, PhD, Principal investigator, University of SheffieldCatherine Davies, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854462
- Sponsor's protocol ID
- R/139470-11-1-INFERENCE
- Status last verified
- May 2018
- First submitted
- 27 Jul 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Yes. IPD will be archived in accordance with the guidelines and protocol of the University of Sheffield, the UK Data Archive and the ESRC's Research Data Policy. With parents' permission, data will be made available in a timely manner, after outcomes have been published together with appropriate metadata in line with ESRC policy around data archiving.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial to Test the Effect of Parents' Inference-eliciting Questions During Shared Book Reading on 4-year-olds' Listening Comprehension
- ClinicalTrials.gov ID
- NCT02854462
- Acronym / sponsor ID
- R/139470-11-1-INFERENCE
- Conditions
- Language Development
- Keywords
- Language Development, Shared Picture Book reading, Preschoolers, Inference making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to test whether training parents to ask their children 'inference- eliciting' questions during book reading is effective in promoting story comprehension for 4-year-olds from a range of socio-economic backgrounds.
Detailed description
Language comprehension relies on the ability to make local and global inferences (e.g., inferring what a pronoun refers to, or inferring why a protagonist in a story did something based on information distributed through the text). These skills develop in the preschool years and are demonstrated when children make sense of stories that are read to them. While important for later reading ability and academic success, relatively little is known about whether anything can be done to improve inference-making skills in the preschool years. One possibility is that parent-child book reading would help. During book reading, some parents naturally ask their children questions about the story that would require them to make inferences about the text. The current study is designed to test whether doing this promotes children's ability to make inferences. Half the parents in this study will be given books with inference eliciting questions added to them and will be provided with training about how to ask these questions and respond to their children's answers. The other half of the parents will be given a maths exercise book and asked to spend the same amount of time per day working through this.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Language comprehension intervention | Experimental | Behavioral: Language comprehension interventionThe intervention will run for 4 weeks. Caregivers will be provided with storybooks (e.g., Percy the Park Keeper) that have been amended to include inference-eliciting questions. Caregivers will be trained (with a video) to ask these questions and respond to their children's answers during shared reading sessions. They will be asked to read one book per day. Caregivers will keep a reading diary. |
| Counting intervention | Active comparator | Behavioral: Counting interventionThe intervention will run for 4 weeks. Caregivers will be provided with a book 'At home with counting' that is made up of age appropriate maths exercises. Caregivers will trained (with a video) to work through one page of the book per day. This should take the same amount of time as the activity in the language intervention condition. Caregivers will keep a counting diary. |
Who may qualify
- Ages
- 50 to 56 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- First born Full term (i.e. born no more than 3 weeks prematurely) With birth weight over 2.5 kg Being raised as monolingual English speakers
Key exclusion criteria (1 listed)
- Neither caregivers nor infants have any significant known physical, mental or learning disability.
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 |
|---|---|---|
| Language comprehension intervention | Behavioural | Language comprehension intervention |
| Counting intervention | Behavioural | Counting intervention |
Primary outcome
Change after 4 weeks in children's ability to answer inference questions.
Time frame: Baseline: when child is 4 years 3 months. Post test: 4 weeks post intervention
An age-appropriate test of inferencing ability has been developed for this study including vignettes developed by the Language and Reading Research Consortium. Children listen to short vignettes and are then asked questions that require them to make local and global inferences based on the information in the stories.
1 secondary outcome
Change in NFER baseline assessment
Time frame: Baseline: when child is 4 years 3 months - 4 years 6 months. Post test: 4 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Individual participant dataSharing planned: Yes. Yes. IPD will be archived in accordance with the guidelines and protocol of the University of Sheffield, the UK Data Archive and the ESRC's Research Data Policy. With parents' permission, data will be made available in a timely manner, after outcomes have been published together with appropriate metadata in line with ESRC policy around data archiving.
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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.
Danielle E Matthews, PhD principal investigator
University of Sheffield
Catherine Davies, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language comprehension intervention and Counting intervention in people with Language Development, run by University of Sheffield 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change after 4 weeks in children's ability to answer inference questions. (time frame: Baseline: when child is 4 years 3 months. Post test: 4 weeks post intervention). 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 4 May 2018.