<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03268928</url>
  </required_header>
  <id_info>
    <org_study_id>1869</org_study_id>
    <nct_id>NCT03268928</nct_id>
  </id_info>
  <brief_title>Evaluating the Impact of Story Starters on Children's Language Development</brief_title>
  <official_title>Evaluating the Impact of Story Starters on Children's Language Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Julian Pine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liverpool</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this project is to evaluate whether Beanstalk's 'Story Starters' intervention is&#xD;
      effective in boosting vocabulary and grammatical development in young children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children who read regularly with their parents or carers tend to learn language faster, enter&#xD;
      school with a larger vocabulary of words and become more successful readers in school.&#xD;
      Because of this, local authorities often commission services to promote family-based shared&#xD;
      book reading. However, recent studies suggest that shared reading interventions work less&#xD;
      effectively for children from disadvantaged backgrounds than originally thought, particularly&#xD;
      when their parents have lower levels of education. This means that there is a danger that the&#xD;
      benefits of shared reading will be restricted to children from more affluent homes and not&#xD;
      get through to those who need them most. To solve this problem, there is a need to develop a&#xD;
      better understanding of how reading interventions work and to evaluate existing shared&#xD;
      reading interventions to determine whether they are effective in promoting young children's&#xD;
      language development.&#xD;
&#xD;
      The aim of this project is to evaluate whether Beanstalk's 'Story Starters' intervention is&#xD;
      effective in boosting vocabulary and grammatical development in young children. Story&#xD;
      Starters is a reading intervention delivered by Beanstalk, a national children's literacy&#xD;
      charity committed to ensuring no child faces the severe consequences of illiteracy. Beanstalk&#xD;
      trains volunteers to provide caring and fun one-to-one support to disadvantaged children aged&#xD;
      3 and 4 in local nurseries, aiding their language development.&#xD;
&#xD;
      The project will compare the effects of the 'Story Starters' intervention against a wait-list&#xD;
      control group. Children in the intervention group will receive the Story Starters&#xD;
      intervention, delivered by a trained Beanstalk volunteer, at their preschool for six months.&#xD;
      The trained volunteer will visit the child twice a week and deliver a one-to-one 20 minute&#xD;
      book reading and play session. Children in the intervention group will also receive a new&#xD;
      book each month which will be sent to their home address by Dolly Parton's Imagination&#xD;
      Library.&#xD;
&#xD;
      Children in the wait list control group will also receive a new book each month from Dolly&#xD;
      Parton's Imagination Library but they will not receive the 'Story Starters' intervention&#xD;
      until after the project has ended.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline language skills - CELF</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline receptive vocabulary</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline phonological awareness</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline language skills - the WellComm Screening tool</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fidelity to the intervention by the Beanstalk volunteer</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child engagement</measure>
    <time_frame>6 months</time_frame>
    <description>Video recordings of the trained Beanstalk volunteers delivering 'Story Starter' sessions will be analysed to measure level of child engagement (Kucirkova, Messer &amp; Whitelock, 2012). This will include coding rate of pointing, rate of smiles and laughs, rate of less engaged behaviours and rate of vocal activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volunteer engagement</measure>
    <time_frame>6 months</time_frame>
    <description>Video recordings of the trained Beanstalk volunteers delivering 'Story Starter' sessions will be analysed to measure level of volunteer engagement (Kucirkova, Messer &amp; Whitelock, 2012). This will include coding rate of pointing, rate of smiles and laughs, rate of less engaged behaviours and rate of vocal activity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Language Development</condition>
  <arm_group>
    <arm_group_label>Story Starters Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
Each child will receive one new book per month delivered to their home address by Dolly Parton's Imagination Library.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.&#xD;
Each child will receive one new book per month delivered to their home address by Dolly Parton's Imagination Library.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Story Starters Intervention</intervention_name>
    <description>Shared reading intervention</description>
    <arm_group_label>Story Starters Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wait-list Control</intervention_name>
    <description>Wait-list control</description>
    <arm_group_label>Wait-list Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All families will be included unless they fit the exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children born before 37 weeks gestation (premature)&#xD;
&#xD;
          -  Children who weighed less than 5lb 9oz at birth (low birth weight)&#xD;
&#xD;
          -  Children who have had an ear infection/glue ear for longer than 3 months, 4-6 ear&#xD;
             infections within a 6 month period or another identified hearing problem (e.g. at&#xD;
             newborn hearing screening)&#xD;
&#xD;
          -  Children with an identified developmental disability (e.g. Cerebral Palsy, Autism&#xD;
             Spectrum Disorder, Fragile X syndrome, Muscular dystrophy, Di George syndrome, Down's&#xD;
             syndrome, Williams syndrome)&#xD;
&#xD;
          -  Children with a hearing or visual impairment&#xD;
&#xD;
          -  Children who hear another language (not English) for 1 day or more in a typical week&#xD;
             (please note that this also excludes children of parents who do not speak English)&#xD;
&#xD;
          -  Children whose parents have a learning disability which puts their children at risk of&#xD;
             language delay and excludes the parents from giving informed consent on their own and&#xD;
             on their children's behalf.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julian Pine, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Liverpool</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liverpool Language Lab at the University of Liverpool</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L69 7ZA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>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</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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</citation>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Liverpool</investigator_affiliation>
    <investigator_full_name>Julian Pine</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Shared Book Reading</keyword>
  <keyword>Language Development</keyword>
  <keyword>Syntax</keyword>
  <keyword>Vocabulary</keyword>
  <keyword>Phonological Awareness</keyword>
  <keyword>Young Children</keyword>
  <keyword>Randomised Control Trial</keyword>
  <keyword>Language Intervention</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03268928
org study id: 1869
nct id: NCT03268928
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in baseline language skills - CELF
time frame: Baseline, 6 months and 12 months
description: 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.
measure: Change in baseline receptive vocabulary
time frame: Baseline, 6 months and 12 months
description: 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.
measure: Change in baseline phonological awareness
time frame: Baseline, 6 months and 12 months
description: 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.
measure: Change in baseline language skills - the WellComm Screening tool
time frame: Baseline, 6 months and 12 months
description: 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.
measure: Fidelity to the intervention by the Beanstalk volunteer
time frame: 6 months
description: 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.
measure: Child engagement
time frame: 6 months
description: 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.
measure: Volunteer engagement
time frame: 6 months
description: 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.
arm group label: Story Starters Intervention
arm group type: Experimental
description: 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.
arm group label: Wait-list Control
arm group type: Other
description: 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.
intervention type: Behavioral
intervention name: Story Starters Intervention
description: Shared reading intervention
arm group label: Story Starters Intervention
intervention type: Behavioral
intervention name: Wait-list Control
description: Wait-list control
arm group label: Wait-list Control
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julian Pine, PhD
role: Principal Investigator
affiliation: The University of Liverpool
facility: 
country: United Kingdom
citation: 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
citation: 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.
citation: 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
responsible party type: Sponsor-Investigator
investigator affiliation: University of Liverpool
investigator full name: Julian Pine
investigator title: Professor