NCT03268928

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

September 4, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 17, 2019

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

August 25, 2017

Last Update Submit

April 16, 2019

Conditions

Keywords

Shared Book ReadingLanguage DevelopmentSyntaxVocabularyPhonological AwarenessYoung ChildrenRandomised Control TrialLanguage Intervention

Outcome Measures

Primary Outcomes (4)

  • Change in baseline language skills - CELF

    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

    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

    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

    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 Outcomes (3)

  • Fidelity to the intervention by the Beanstalk volunteer

    6 months

  • Child engagement

    6 months

  • Volunteer engagement

    6 months

Study Arms (2)

Story Starters Intervention

EXPERIMENTAL

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

Wait-list Control

OTHER

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

Interventions

Shared reading intervention

Story Starters Intervention

Wait-list control

Wait-list Control

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool Language Lab at the University of Liverpool

Liverpool, Merseyside, L69 7ZA, United Kingdom

Location

Related Publications (3)

  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND

Study Officials

  • Julian Pine, PhD

    The University of Liverpool

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 31, 2017

Study Start

September 4, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

April 17, 2019

Record last verified: 2018-05

Locations