Evaluating the Impact of Story Starters on Children's Language Development

April 16, 2019 updated by: Julian Pine
The aim of this project is to evaluate whether Beanstalk's 'Story Starters' intervention is effective in boosting vocabulary and grammatical development in young children.

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

Children who read regularly with their parents or carers tend to learn language faster, enter school with a larger vocabulary of words and become more successful readers in school. Because of this, local authorities often commission services to promote family-based shared book reading. However, recent studies suggest that shared reading interventions work less effectively for children from disadvantaged backgrounds than originally thought, particularly when their parents have lower levels of education. This means that there is a danger that the benefits of shared reading will be restricted to children from more affluent homes and not get through to those who need them most. To solve this problem, there is a need to develop a better understanding of how reading interventions work and to evaluate existing shared reading interventions to determine whether they are effective in promoting young children's language development.

The aim of this project is to evaluate whether Beanstalk's 'Story Starters' intervention is effective in boosting vocabulary and grammatical development in young children. Story Starters is a reading intervention delivered by Beanstalk, a national children's literacy charity committed to ensuring no child faces the severe consequences of illiteracy. Beanstalk trains volunteers to provide caring and fun one-to-one support to disadvantaged children aged 3 and 4 in local nurseries, aiding their language development.

The project will compare the effects of the 'Story Starters' intervention against a wait-list control group. Children in the intervention group will receive the Story Starters intervention, delivered by a trained Beanstalk volunteer, at their preschool for six months. The trained volunteer will visit the child twice a week and deliver a one-to-one 20 minute book reading and play session. Children in the intervention group will also receive a new book each month which will be sent to their home address by Dolly Parton's Imagination Library.

Children in the wait list control group will also receive a new book each month from Dolly Parton's Imagination Library but they will not receive the 'Story Starters' intervention until after the project has ended.

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.
198

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

3 years to 5 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
  • 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.
EXPERIMENTAL: Story Starters Intervention

Children will receive the the Story Starters intervention for six months. Each child will be visited by a trained Story Starter volunteer twice a week while the child is in preschool. The sessions will last 20 minutes and in each session the Story Starter volunteer and child will read books and play with toys. The Story Starter volunteers will keep a record of the number of sessions each child attends.

Each child will receive one new book per month delivered to their home address by Dolly Parton's Imagination Library.
Behavioral: Story Starters Intervention
Shared reading intervention
OTHER: Wait-list Control

Children in the wait-list control arm will continue to attend preschool as normal during the randomised controlled trial (RCT) and will receive the Story Starters intervention after the RCT has finished.

Each child will receive one new book per month delivered to their home address by Dolly Parton's Imagination Library.
Behavioral: Wait-list Control
Wait-list control

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 - CELF
Time Frame: Baseline, 6 months and 12 months
The Clinical Evaluation of Language Fundamentals - Preschool 2 United Kingdom (CELF Preschool-2) will be administered. This is a published standardized measure of the language knowledge of individual children. The investigators will use three subtests to calculate each child's core language score. The three subtests measure knowledge of sentence structure, knowledge of word structure and expressive vocabulary.
Baseline, 6 months and 12 months
Change in baseline receptive vocabulary
Time Frame: Baseline, 6 months and 12 months
The British Picture Vocabulary Scale (BPVS) will be administered. This is a published standardised measure and will be used to measure receptive vocabulary of individual children.
Baseline, 6 months and 12 months
Change in baseline phonological awareness
Time Frame: Baseline, 6 months and 12 months
The full Preschool Inventory of Phonological Awareness (PIPA) will be administered. This is a published standardised measure of phonological awareness of individual children. The investigators will use the PIPA to measure, rhyme awareness, syllable segmentation, alliteration awareness, phoneme isolation, phoneme segmentation and letter knowledge.
Baseline, 6 months and 12 months
Change in baseline language skills - the WellComm Screening tool
Time Frame: Baseline, 6 months and 12 months
The WellComm Screening Tool will be administered. This is a published measure of language skills of individual children. The investigators will use the WellComm to measure expressive and receptive language skills.
Baseline, 6 months and 12 months

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
Fidelity to the intervention by the Beanstalk volunteer
Time Frame: 6 months
Video recordings of the trained Beanstalk volunteers delivering 'Story Starter' sessions will be analysed to measure fidelity to the intervention and presence of target book reading behaviours. This will include coding for the presence of Dialogic book reading behaviours (prompting, evaluating, expanding and repeating). This will allow measurement of whether the volunteer adheres to the Story Starter intervention.
6 months
Child engagement
Time Frame: 6 months
Video recordings of the trained Beanstalk volunteers delivering 'Story Starter' sessions will be analysed to measure level of child engagement (Kucirkova, Messer & Whitelock, 2012). This will include coding rate of pointing, rate of smiles and laughs, rate of less engaged behaviours and rate of vocal activity.
6 months
Volunteer engagement
Time Frame: 6 months
Video recordings of the trained Beanstalk volunteers delivering 'Story Starter' sessions will be analysed to measure level of volunteer engagement (Kucirkova, Messer & Whitelock, 2012). This will include coding rate of pointing, rate of smiles and laughs, rate of less engaged behaviours and rate of vocal activity.
6 months

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.
Julian Pine

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: Julian Pine, 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

  • Kucirkova, N, Messer, D, Whitelock, D. Parents reading with their toddlers: the role of personalisation in book engagement. Journal of Early Childhood Literacy, 13(4): 445-470, 2012
  • Bus AG, van IJzendoorn MH, Pellegrini AD. Joint book reading makes for success in learning to read: A meta-analysis on intergenerational transmission of literacy. Review of Educational Research, 65: 1-21, 1995.
  • Mol SE, Bus AG, de Jong MT, Smeets DJH. Added value of dialogic parent-child book readings: A meta-analysis. Early Education and Development, 19: 7-26, 2008

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.
September 4, 2017

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.
March 31, 2019

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.
March 31, 2019

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).
August 25, 2017

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.
August 30, 2017

First Posted (ACTUAL)

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.
August 31, 2017

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.
April 17, 2019

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.
April 16, 2019

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.
May 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.
  • 1869

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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