- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02854462
Supporting Children's School Readiness.
May 1, 2018 updated by: Danielle Matthews, University of Sheffield
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Yorkshire
-
Sheffield, South Yorkshire, United Kingdom, S10 2TN
- University of Sheffield
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 4 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
Exclusion Criteria:
Neither caregivers nor infants have any significant known physical, mental or learning disability.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Language comprehension intervention
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.
|
|
Active Comparator: Counting intervention
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline: when child is 4 years 3 months. Post test: 4 weeks post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
This is an age appropriate test of maths and language ability.
|
Baseline: when child is 4 years 3 months - 4 years 6 months. Post test: 4 weeks post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Danielle E Matthews, PhD, University of Sheffield
- Principal Investigator: Catherine Davies, PhD, University of Leeds
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2016
Primary Completion (Actual)
March 20, 2018
Study Completion (Actual)
March 22, 2018
Study Registration Dates
First Submitted
July 27, 2016
First Submitted That Met QC Criteria
August 2, 2016
First Posted (Estimate)
August 3, 2016
Study Record Updates
Last Update Posted (Actual)
May 4, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- R/139470-11-1-INFERENCE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Language Development
-
Temple UniversityWilliam Penn FoundationRecruitingLanguage Development | Early Intervention | Language, ChildUnited States
-
Hugo W. Moser Research Institute at Kennedy Krieger...Johns Hopkins UniversityNot yet recruitingChild Development | Developmental Delay | Infant Development | Language Development
-
University of SheffieldUniversity of Liverpool; University of Manchester; University of MelbourneActive, not recruiting
-
Assiut UniversityCompleted
-
University of SheffieldCompleted
-
University of ChicagoCompleted
-
University of ChicagoChildrens Services Council; St. Marys Medical Center; Soma Medical Center; Home...Withdrawn
-
Caroline RowlandCompletedLanguage DevelopmentUnited Kingdom
-
University of MinnesotaCompletedLanguage DevelopmentUnited States
Clinical Trials on Language comprehension intervention
-
University of Alabama, TuscaloosaUniversity of Alabama at BirminghamRecruitingAutism Spectrum Disorder | Autism | Reading ProblemUnited States
-
Alexandria UniversityRecruitingDevelopmental Language Disorder | Hearing Impaired ChildrenEgypt
-
Heidelberg UniversityUnknownLanguage Delay | Developmental Language DisordersGermany
-
National Institute on Deafness and Other Communication...Completed
-
Baylor UniversityNational Institutes of Health (NIH); National Institute on Deafness and Other...RecruitingIntellectual Disability | Developmental DisabilityUnited States
-
University of ArizonaRecruitingLanguage Disorders | Primary Progressive Aphasia | Aphasia, Acquired | Stroke, CerebrovascularUnited States
-
Riphah International UniversityRecruitingHearing Impaired ChildrenPakistan
-
Florida International UniversityUniversity of South Florida; Florida State University; Nova Southeastern UniversityRecruitingAttention Deficit Hyperactivity DisorderUnited States
-
Northwestern UniversityNational Institutes of Health (NIH); National Institute on Deafness and Other...Completed
-
Temple UniversityWilliam Penn FoundationRecruitingLanguage Development | Early Intervention | Language, ChildUnited States