Language DevelopmentNCT02780557
How Parents Can Help Babies Learn to Talk With Picture Books.
A study testing Contingent Reading 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 giving parents advice about book reading is effective in promoting language learning for infants from a range of socio-economic backgrounds. Read more about this study
- Who is it for?
- Ages 11 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Development
- What is being tested?
- Contingent Reading Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 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 11 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants must be:
- first born and singletons
- full term (i.e. born no more than 3 weeks prematurely)
- with birth weight over 2.5 kg.
- Primary caregivers must:
- work less than 24 hours per week (i.e., be the caregiver the child spends most time with)
- be raising their child as monolingual English speakers.
Who cannot join
- Neither caregivers nor infants must 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 Parent Contingent Talk During Shared Book Reading on Infant Language Learning.
The aim of this project is to test whether giving parents advice about book reading is effective in promoting language learning for infants from a range of socio-economic backgrounds.
Read the detailed description
Children from disadvantaged families tend to have limited language skills compared to their advantaged peers. While many factors contribute to language ability, two aspects of the early caregiving environment are known to be correlated with child language outcomes 1) caregiver-child book reading and 2) caregiver contingent talk. Contingent talk refers to a style of communication whereby the caregiver talks about what is in their infant's current focus of attention. This style of talking can be facilitated when parents read books with their babies. The aim of this research is to establish whether asking parents to engage in contingent talk in the context of book reading promotes vocabulary learning. This study will compare the effects of an intervention to promote contingent talk against a control where parents are given books but not given any training in how to read them in a contingent manner. The study will include children from socio-economically advantaged and disadvantaged families.
- Conditions
- Language Development
- Being tested
- Contingent Reading Intervention, Book Provision Control
- Keywords
- Vocabulary, Book reading, Infancy, Parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingent Reading InterventionBehavioural
Caregivers will be provided with 6 picture books. They will be trained to use contingent talk when looking at picture books with their infants. They will be asked to spend 10 mintues each day engaging in contingent talk while looking at picture books. The intervention will run for 4 months. Parents will be asked to keep a daily reading diary.
Book Provision ControlBehavioural
Caregivers will be provided with 6 picture books. They will not be trained to read with their child. They will receive information from other sources (e.g. health visitors and Book Start schemes) as normal.
| Study group | Role | What they receive |
|---|---|---|
| Contingent Reading Intervention | Experimental | Not described Receives: Behavioral: Contingent Reading Intervention |
| Book Provision Control | Other | Not described Receives: Behavioral: Book Provision Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in infant expressive vocabulary
Parents will complete a standardised assessment of vocabulary, the MacArthur-Bates Communicative Development Inventory (CDI).
Measured: Baseline: 11 months, outcome: 15 months
Secondary outcomes (3)
Change in caregiver reported frequency of reading
Parents will complete a questionnaire about how frequently they read with their child.
Measured: Baseline: 11 months, outcome: 15 months
Infant Real Time Language Understanding: Accuracy
Infants' real-time comprehension of familiar words will be assessed at 15 months using the looking-while-listening (LWL) procedure (Fernald et al., 2008). Infants will sit in front of a computer screen with a picture on either side of it (e.g., a bottle and a shoe). We will measure the accuracy with which they look to the correct picture upon hearing a word that describes it.
Measured: 15 months
Infant Real Time Language Understanding: Reaction Time
Infants' real-time comprehension of familiar words will be assessed at 15 months using the looking-while-listening (LWL) procedure (Fernald et al., 2008). We will measure the time it takes the child to look from a distractor to the target.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study start24 Aug 2016
- Primary completion30 Jan 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Matthews, University of Sheffield
- Investigators
- Danielle E Matthews, PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780557
- Sponsor's protocol ID
- R/139470-11-1-INFANCY
- Status last verified
- May 2018
- First submitted
- 19 May 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: With participants' permission, IPD will be archived in accordance with the guidelines of the University of Sheffield, the UK Data Archive and the ESRC's Research Data Policy.
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 Parent Contingent Talk During Shared Book Reading on Infant Language Learning.
- ClinicalTrials.gov ID
- NCT02780557
- Acronym / sponsor ID
- R/139470-11-1-INFANCY
- Conditions
- Language Development
- Keywords
- Vocabulary, Book reading, Infancy, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 23 May 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 giving parents advice about book reading is effective in promoting language learning for infants from a range of socio-economic backgrounds.
Detailed description
Children from disadvantaged families tend to have limited language skills compared to their advantaged peers. While many factors contribute to language ability, two aspects of the early caregiving environment are known to be correlated with child language outcomes 1) caregiver-child book reading and 2) caregiver contingent talk. Contingent talk refers to a style of communication whereby the caregiver talks about what is in their infant's current focus of attention. This style of talking can be facilitated when parents read books with their babies. The aim of this research is to establish whether asking parents to engage in contingent talk in the context of book reading promotes vocabulary learning. This study will compare the effects of an intervention to promote contingent talk against a control where parents are given books but not given any training in how to read them in a contingent manner. The study will include children from socio-economically advantaged and disadvantaged families.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingent Reading Intervention | Experimental | Behavioral: Contingent Reading Intervention |
| Book Provision Control | Other | Behavioral: Book Provision Control |
Who may qualify
- Ages
- 11 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- first born and singletons
- full term (i.e. born no more than 3 weeks prematurely)
- with birth weight over 2.5 kg.
- work less than 24 hours per week (i.e., be the caregiver the child spends most time with)
- be raising their child as monolingual English speakers.
Key exclusion criteria (1 listed)
- Neither caregivers nor infants must 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 |
|---|---|---|
| Contingent Reading InterventionCaregivers will be provided with 6 picture books. They will be trained to use contingent talk when looking at picture books with their infants. They will be asked to spend 10 mintues each day engaging in contingent talk while looking at picture books. The intervention will run for 4 months. Parents will be asked to keep a daily reading diary. | Behavioural | Contingent Reading Intervention |
| Book Provision ControlCaregivers will be provided with 6 picture books. They will not be trained to read with their child. They will receive information from other sources (e.g. health visitors and Book Start schemes) as normal. | Behavioural | Book Provision Control |
Primary outcome
Change in infant expressive vocabulary
Time frame: Baseline: 11 months, outcome: 15 months
Parents will complete a standardised assessment of vocabulary, the MacArthur-Bates Communicative Development Inventory (CDI).
3 secondary outcomes
Change in caregiver reported frequency of reading
Time frame: Baseline: 11 months, outcome: 15 months
Infant Real Time Language Understanding: Accuracy
Time frame: 15 months
Infant Real Time Language Understanding: Reaction Time
Time frame: 15 months
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. With participants' permission, IPD will be archived in accordance with the guidelines of the University of Sheffield, the UK Data Archive and the ESRC's Research Data Policy.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingent Reading 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 7 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 in infant expressive vocabulary (time frame: Baseline: 11 months, outcome: 15 months). 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.