Evaluating the Effectiveness of the Reader Organisation's Get Into Reading Intervention

October 22, 2018 updated by: Caroline Rowland
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L69 7ZA
        • Livepool Language Lab at the University of Liverpool

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All families will be included unless they fit the exclusion criteria below.

Exclusion Criteria:

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.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The Reader Organisation's Shared Reading Programme
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.
Behavioral: The Reader Organisation's Shared Reading Programme
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.
Active Comparator: Shared Reading control
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.
Behavioral: Shared Reading control
Parents and children will attend a weekly shared reading group at a library for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 weeks after intervention and 6 months after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
Baseline, 4 weeks after intervention and 6 months after the intervention
Parent Child Questionnaire
Time Frame: Baseline and 4 weeks after intervention
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.
Baseline and 4 weeks after intervention
Family Questionnaire
Time Frame: Baseline
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.
Baseline
Family Reading Questionnaire
Time Frame: Baseline and 4 weeks after intervention
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).
Baseline and 4 weeks after intervention
Children's Title Checklist
Time Frame: Baseline and 4 weeks after intervention
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.
Baseline and 4 weeks after intervention
Children's Author Checklist
Time Frame: Baseline and 4 weeks after intervention
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.
Baseline and 4 weeks after intervention
The Reader Organisation's Baseline Questionnaire
Time Frame: Baseline
The Reader Organisation's Baseline Questionnaire assess parents' attitudes towards reading and barriers towards reading.
Baseline
The Reader Organisation's Follow Up Questionnaire
Time Frame: 4 weeks after intervention
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.
4 weeks after intervention
Leuven Scale during Dyadic Videoed Book-Reading Sessions
Time Frame: Baseline and 4 weeks after intervention
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).
Baseline and 4 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Caroline Rowland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caroline F Rowland, PhD, University of Liverpool

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ES/M003752/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

With the consent of participating adults, the data will be donated to the UK data archive.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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