Language DevelopmentNCT02659579
Evaluating the Effectiveness of the Reader Organisation's Get Into Reading Intervention
A study testing The Reader Organisation's Shared Reading Programme in people with Language Development, run by Caroline Rowland at 1 site in United Kingdom.
Trial summary
The investigators will evaluate the effectiveness of a parent-child shared reading intervention run by The Reader Organisation. The investigators will be asking parents and children across Liverpool to either (i) attend a weekly shared reading programme or (b) to attend a weekly children's reading group at a library. Read more about this study
- Who is it for?
- Ages 36 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Development
- What is being tested?
- The Reader Organisation's Shared Reading Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Feb 2017
- 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 36 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All families will be included unless they fit the exclusion criteria below.
Who cannot join
- This is a study of typically developing English-learning children. The following exclusion criteria are designed to exclude families in which the target child is at risk of atypical or delayed language acquisition:
- Children born before 37 weeks gestation (premature)
- Children who weighed less than 5lb 9oz at birth (low birth weight)
- Children who have had an ear infection/glue ear for longer than 3 months, 4-6 ear infections within a 6 month period or another identified hearing problem (e.g. at newborn hearing screening)
- Children with an identified developmental disability (e.g. Cerebral Palsy, Autism Spectrum Disorder, Fragile X syndrome, Muscular dystrophy, Di George syndrome, Down's syndrome, Williams syndrome)
- Children with a hearing or visual impairment
- Children who hear another language (not English) for 1 day or more in a typical week (please note that this also excludes children of parents who do not speak English)
- Children whose parents have a learning disability which puts their children at risk of language delay and excludes the parents from giving informed consent on their own and on their children's behalf.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Livepool Language Lab at the University of Liverpool
Liverpool, Merseyside, L69 7ZA
About this study
The investigators will evaluate the effectiveness of a parent-child shared reading intervention run by The Reader Organisation. The investigators will be asking parents and children across Liverpool to either (i) attend a weekly shared reading programme or (b) to attend a weekly children's reading group at a library. The investigators will look at how the reading groups affect children's language development, by comparing children's language development before having gone to these groups and after they have attended these groups.
Read the detailed description
This is a Randomised Control Trial to test whether The Reader Organisation's Shared Reading Programme is more effective at improving the language development of children than a free library reading group. Intervention group: Fifty parents of children (3 to 4-years of age) will be recruited to take part in a 8 weeks long shared reading programme. The shared reading programme is comprised of two different modules: a) 'Magical Storytimes', in which a collection of shared book reading sessions are led by a project worker and b) 'Stories for You and Yours', in which parents will be taught how to choose books and read interactively with their child. Control group: Fifty further families, matched for age and background will be recruited to a reading control group and asked to attend a weekly shared reading group at a library where parents/children will read in a shared pre-school library reading group, coordinated by a group facilitator. Location: The Shared Reading Programme will take place in the child's nursery (in nurseries across Liverpool). Control group parents and children will attend a weekly reading group at a library. All standardised tests, for all children, will take place in the child's nursery. Language gains from pre- to post- intervention will be measured.
- Conditions
- Language Development
- Being tested
- The Reader Organisation's Shared Reading Programme, Shared Reading control
- Keywords
- Shared Book Reading, Vocabulary, Language Development, Young Children, Randomised Control Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Reader Organisation's Shared Reading ProgrammeBehavioural
In The Reader Organisation's Shared Reading Programme, parents and children will attend weekly shared book reading sessions for 8 weeks which focus predominately on how to read interactively with children.
Shared Reading controlBehavioural
Parents and children will attend a weekly shared reading group at a library for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| The Reader Organisation's Shared Reading Programme | Experimental | In the Reader Organisation's Shared Reading Programme, parents and children will attend The Reader Organisation's weekly shared reading programme for 8 weeks. The programme consists of two different modules. Parents will attend 'Magical Storytimes' with their children, in which a collection of shared book reading sessions are led by a project worker. Parents will also attend sessions on their own ('Stories for you and Yours') in which they will be informed how to choose books and read interactively with their child. Receives: Behavioral: The Reader Organisation's Shared Reading Programme |
| Shared Reading control | Active comparator | In the Shared Reading control parents and children will attend a weekly shared reading group at a library for 8 weeks where parents/children will read in a shared reading group which will be coordinated by a group facilitator. Receives: Behavioral: Shared Reading control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline language skills: British Picture Vocabulary Scale: Third edition
The British Picture Vocabulary Scale: Third edition (BPVS3) will be administered to children baseline, 4 weeks, and 6 months after intervention. The BPVS3 assesses a child's receptive vocabulary; for each question, the researcher says a word and the child responds by selecting a picture from four options that best illustrates the word's meaning.
Measured: Baseline and 4 weeks after intervention and 6 months after the intervention
Secondary outcomes (9)
Change in baseline language skills: Clinical Evaluation of Language Fundamentals - Preschool 2 UK.
The Clinical Evaluation of Language Fundamentals - Preschool 2 UK (CELF Preschool-2) will be administered to children at baseline, 4 weeks, and 6 weeks after intervention.The CELF Preschool-2 is a published measure of linguistic knowledge of individual children which measures a broad range of language skills in young children. Specifically, we will use three subset tests from the CELF Preschool-2. The "sentence structure" subset will measure the children's understanding of simple and complex sentence structures. A sentence is read to the child and the child chooses, from a set of pictures, which picture ''goes with'' that sentence.The "word structure" subset measures the children's understanding of simple and complex word structures. A sentence is read about a particular picture and the child is asked to finish the sentence.The "expressive vocabulary" subset evaluate a child's ability to label pictures of people, objects, and actions.
Measured: Baseline, 4 weeks after intervention and 6 months after the intervention
Parent Child Questionnaire
The Parent Child Questionnaire contains 78 items and assesses: satisfaction with parenting, parent's interaction with and knowledge of his or her child, parent's perception of how he/she communicates with a child, parents' experience of disciplining their child, parent's ability to promote a child's independence and parents' attitudes about gender roles in parenting.
Measured: Baseline and 4 weeks after intervention
Family Questionnaire
The Family Questionnaire records relevant demographic information (e.g. socio-economic status, parents' education, family language use, ethnicity, children's medical history) that was devised for the Economic Social Research Council funded United Kingdom Communicative Development Inventory study. This allows us to create a composite individual socio-economic background variable using maternal education and household income in order to identify high and low socio-economic status families and to confirm that the participant children are typically developing monolinguals.
Measured: Baseline
Family Reading Questionnaire
The Family Reading Questionnaire examines frequency of storybook reading, reading requests and child library visits, number of books and children's books in the home, parental reading habits, reading onset, and frequency of parent teaching behaviours about reading, such as teaching about print knowledge (e.g. how often do you teach your child how to print words/read words?) questions about book choice (e.g. books read in the last week, child's favourite book).
Measured: Baseline and 4 weeks after intervention
Children's Title Checklist
The Children's Title Checklist indirectly measure a child's storybook exposure by assessing the parent's knowledge of children's book titles (Children's Title Checklist). The Children's Title Checklist consists of 40 titles of popular children's books and 20 foils.
Measured: Baseline and 4 weeks after intervention
Children's Author Checklist
The Children's Author Checklist indirectly measures a child's storybook exposure by assessing the parent's knowledge of authors. The Children's Author Checklist consists of 40 names of authors of popular children's books and 20 foils.
Measured: Baseline and 4 weeks after intervention
The Reader Organisation's Baseline Questionnaire
The Reader Organisation's Baseline Questionnaire assess parents' attitudes towards reading and barriers towards reading.
Measured: Baseline
The Reader Organisation's Follow Up Questionnaire
The Reader Organisation's Follow Up Questionnaire assess parents' attitudes towards reading and barriers towards reading. Parents are also asked questions about their own experience of the intervention itself.
Measured: 4 weeks after intervention
Leuven Scale during Dyadic Videoed Book-Reading Sessions
The Leuven scale will be used to assess the child's active engagement during videoed dyadic book-reading sessions. There are 5 levels of engagements: extremely low (e.g. the child shows hardly any activity), low (e.g. the child shows some degree of activity which is often interrupted), moderate (e.g. the child is busy the whole time, but without real concentration), high (e.g. there are clear signs of involvement, but these are not always present to their full extent) and extremely high (e.g. during the observation of learning the child is continually engaged in the activity and completely absorbed in it).
Measured: Baseline and 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caroline Rowland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caroline Rowland, University of Liverpool
- Investigators
- Caroline F Rowland, PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659579
- Sponsor's protocol ID
- ES/M003752/1
- Status last verified
- Oct 2018
- First submitted
- 7 Jan 2016
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: With the consent of participating adults, the data will be donated to the UK data archive.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of the Reader Organisation's Get Into Reading Intervention
- ClinicalTrials.gov ID
- NCT02659579
- Acronym / sponsor ID
- ES/M003752/1
- Conditions
- Language Development
- Keywords
- Shared Book Reading, Vocabulary, Language Development, Young Children, Randomised Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Caroline RowlandUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 20 Jan 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 investigators will evaluate the effectiveness of a parent-child shared reading intervention run by The Reader Organisation. The investigators will be asking parents and children across Liverpool to either (i) attend a weekly shared reading programme or (b) to attend a weekly children's reading group at a library. The investigators will look at how the reading groups affect children's language development, by comparing children's language development before having gone to these groups and after they have attended these groups.
Detailed description
This is a Randomised Control Trial to test whether The Reader Organisation's Shared Reading Programme is more effective at improving the language development of children than a free library reading group. Intervention group: Fifty parents of children (3 to 4-years of age) will be recruited to take part in a 8 weeks long shared reading programme. The shared reading programme is comprised of two different modules: a) 'Magical Storytimes', in which a collection of shared book reading sessions are led by a project worker and b) 'Stories for You and Yours', in which parents will be taught how to choose books and read interactively with their child. Control group: Fifty further families, matched for age and background will be recruited to a reading control group and asked to attend a weekly shared reading group at a library where parents/children will read in a shared pre-school library reading group, coordinated by a group facilitator. Location: The Shared Reading Programme will take place in the child's nursery (in nurseries across Liverpool). Control group parents and children will attend a weekly reading group at a library. All standardised tests, for all children, will take place in the child's nursery. Language gains from pre- to post- intervention will be measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Reader Organisation's Shared Reading Programme | Experimental | Behavioral: The Reader Organisation's Shared Reading ProgrammeIn the Reader Organisation's Shared Reading Programme, parents and children will attend The Reader Organisation's weekly shared reading programme for 8 weeks. The programme consists of two different modules. Parents will attend 'Magical Storytimes' with their children, in which a collection of shared book reading sessions are led by a project worker. Parents will also attend sessions on their own ('Stories for you and Yours') in which they will be informed how to choose books and read interactively with their child. |
| Shared Reading control | Active comparator | Behavioral: Shared Reading controlIn the Shared Reading control parents and children will attend a weekly shared reading group at a library for 8 weeks where parents/children will read in a shared reading group which will be coordinated by a group facilitator. |
Who may qualify
- Ages
- 36 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All families will be included unless they fit the exclusion criteria below.
Key exclusion criteria (8 listed)
- This is a study of typically developing English-learning children. The following exclusion criteria are designed to exclude families in which the target child is at risk of atypical or delayed language acquisition:
- Children born before 37 weeks gestation (premature)
- Children who weighed less than 5lb 9oz at birth (low birth weight)
- Children who have had an ear infection/glue ear for longer than 3 months, 4-6 ear infections within a 6 month period or another identified hearing problem (e.g. at newborn hearing screening)
- Children with an identified developmental disability (e.g. Cerebral Palsy, Autism Spectrum Disorder, Fragile X syndrome, Muscular dystrophy, Di George syndrome, Down's syndrome, Williams syndrome)
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 |
|---|---|---|
| The Reader Organisation's Shared Reading ProgrammeIn The Reader Organisation's Shared Reading Programme, parents and children will attend weekly shared book reading sessions for 8 weeks which focus predominately on how to read interactively with children. | Behavioural | The Reader Organisation's Shared Reading Programme |
| Shared Reading controlParents and children will attend a weekly shared reading group at a library for 8 weeks | Behavioural | Shared Reading control |
Primary outcome
Change in baseline language skills: British Picture Vocabulary Scale: Third edition
Time frame: Baseline and 4 weeks after intervention and 6 months after the intervention
The British Picture Vocabulary Scale: Third edition (BPVS3) will be administered to children baseline, 4 weeks, and 6 months after intervention. The BPVS3 assesses a child's receptive vocabulary; for each question, the researcher says a word and the child responds by selecting a picture from four options that best illustrates the word's meaning.
9 secondary outcomes
Change in baseline language skills: Clinical Evaluation of Language Fundamentals - Preschool 2 UK.
Time frame: Baseline, 4 weeks after intervention and 6 months after the intervention
Parent Child Questionnaire
Time frame: Baseline and 4 weeks after intervention
Family Questionnaire
Time frame: Baseline
Family Reading Questionnaire
Time frame: Baseline and 4 weeks after intervention
Children's Title Checklist
Time frame: Baseline and 4 weeks after intervention
Children's Author Checklist
Time frame: Baseline and 4 weeks after intervention
The Reader Organisation's Baseline Questionnaire
Time frame: Baseline
The Reader Organisation's Follow Up Questionnaire
Time frame: 4 weeks after intervention
Leuven Scale during Dyadic Videoed Book-Reading Sessions
Time frame: Baseline and 4 weeks after 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 24 Oct 2018.
- Individual participant dataSharing planned: Yes. With the consent of participating adults, the data will be donated to the UK data archive.
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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.
Caroline F Rowland, PhD principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Reader Organisation's Shared Reading Programme in people with Language Development, run by Caroline Rowland 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 1 inclusion and 8 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 24 Oct 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 baseline language skills: British Picture Vocabulary Scale: Third edition (time frame: Baseline and 4 weeks after intervention and 6 months after the 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 24 Oct 2018.