Reading Together: How to Promote Children's Language Development Using Family-based Shared Book Reading

September 13, 2018 updated by: Caroline Rowland
The aim of this project is to determine how shared reading promotes child language development, and to use this knowledge to make it an effective language-boosting tool for children from all social and economic backgrounds.

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

Two interventions will be created which are intended to boost children's vocabulary and grammar abilities, and will be assessed on how they are implemented by caregivers across different socio economic groups, and how they affect children's development of these language skills. Previous research has found dialogic reading interventions to be less effective for children from low socio-economic backgrounds. This project will investigate whether a shared reading intervention, designed to require less of a behaviour change from caregivers than dialogic reading, can be used to effectively boost vocabulary and grammar development in children across the whole socio-economic spectrum.

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.
150

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
        • Liverpool 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

2 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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.
Other: Shared Reading Control
Reading Together - Shared Reading Control. The intervention will run for six weeks and the caregivers will be provided with books to read with their children. Caregivers will not be trained to read with their child. The caregivers will be asked to read two books to their child five times a week. Caregivers will keep a reading diary and audio record all shared book reading sessions with their child.
Behavioral: Reading Together - Shared Reading Control
Experimental: Dialogic Reading
Reading Together - Dialogic Reading. The intervention will run for six weeks and the caregivers will be provided with books to read with their children. Caregivers will be trained to read with their child using a dialogic reading style. The caregivers will be asked to read two books to their child five times a week. Caregivers will keep a reading diary and audio record all shared book reading sessions with their child.
Behavioral: Reading Together - Dialogic Reading
Experimental: Pausing for Reading
Reading Together - Pausing for Reading. The intervention will run for six weeks and the caregivers will be provided with books to read with their children. Caregivers will be trained to read with their child using a style which involves pausing, recasting and open questioning. The caregivers will be asked to read two books to their child five times a week. Caregivers will keep a reading diary and audio record all shared book reading sessions with their child.
Behavioral: Reading Together - Pausing for Reading

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 (PLS-5)
Time Frame: Baseline and 6 weeks
The Preschool Language Scale Fifth Edition (PLS-5) Will be administered. This is a published standardized measure of the language knowledge of individual children. The investigators will use both the Auditory Comprehension and Expressive Communication scales to measure vocabulary and grammar knowledge. The PLS-5 standard scores are based on a mean of 100 with a standard deviation of 15. Scores between 85 and 115 are considered to be within the normal range.
Baseline and 6 weeks

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 syntax comprehension (CELF Preschool-2 UK)
Time Frame: Baseline and 6 weeks
The Clinical Evaluation of Language Fundamentals - Preschool 2 UK (CELF Preschool-2) will be administered. This is a published standardized measure of the language knowledge of individual children. The investigators will use the 'Sentence Structure' subtest. This will allow measurement of the children's understanding of a range 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.
Baseline and 6 weeks
Change in baseline caregiver dialogic reading behaviour
Time Frame: Baseline and 6 weeks
10 minute video recordings of the dyads reading books at baseline and 6 weeks will be analysed for the number of target dialogic reading behaviours. This will allow measurement of the caregiver's dialogic reading behaviour pre- and post-intervention.
Baseline and 6 weeks
Change in baseline caregiver pause reading behaviour
Time Frame: Baseline and 6 weeks
10 minute video recordings of the dyads reading books at baseline and 6 weeks will be analysed for the number of target pause reading behaviours. This will allow measurement of the caregiver's pause reading behaviour pre- and post-intervention.
Baseline and 6 weeks

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, The University of Liverpool

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Manz PH , Hughes C , Barnabas E , Bracaliello C , Ginsburg-Block M. A descriptive review and meta-analysis of family-based emergent literacy interventions: To what extent is the research applicable to low-income, ethnic-minority or linguistically-diverse young children? Early Childhood Research Quarterly 25(4): 409-431, 2010.

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

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.
January 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.
April 1, 2018

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.
April 1, 2018

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).
November 24, 2015

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.
December 4, 2015

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.
December 9, 2015

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.
September 14, 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.
September 13, 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.
September 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.
  • RETH000849

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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