NCT02854462

Brief Summary

The aim of this project is to test whether training parents to ask their children 'inference- eliciting' questions during book reading is effective in promoting story comprehension for 4-year-olds from a range of socio-economic backgrounds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

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

July 27, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

August 10, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2018

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

July 27, 2016

Last Update Submit

May 1, 2018

Conditions

Keywords

Language DevelopmentShared Picture Book readingPreschoolersInference making

Outcome Measures

Primary Outcomes (1)

  • Change after 4 weeks in children's ability to answer inference questions.

    An age-appropriate test of inferencing ability has been developed for this study including vignettes developed by the Language and Reading Research Consortium. Children listen to short vignettes and are then asked questions that require them to make local and global inferences based on the information in the stories.

    Baseline: when child is 4 years 3 months. Post test: 4 weeks post intervention

Secondary Outcomes (1)

  • Change in NFER baseline assessment

    Baseline: when child is 4 years 3 months - 4 years 6 months. Post test: 4 weeks post intervention

Study Arms (2)

Language comprehension intervention

EXPERIMENTAL

The intervention will run for 4 weeks. Caregivers will be provided with storybooks (e.g., Percy the Park Keeper) that have been amended to include inference-eliciting questions. Caregivers will be trained (with a video) to ask these questions and respond to their children's answers during shared reading sessions. They will be asked to read one book per day. Caregivers will keep a reading diary.

Behavioral: Language comprehension intervention

Counting intervention

ACTIVE COMPARATOR

The intervention will run for 4 weeks. Caregivers will be provided with a book 'At home with counting' that is made up of age appropriate maths exercises. Caregivers will trained (with a video) to work through one page of the book per day. This should take the same amount of time as the activity in the language intervention condition. Caregivers will keep a counting diary.

Behavioral: Counting intervention

Interventions

Language comprehension intervention
Counting intervention

Eligibility Criteria

Age50 Months - 56 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children are:
  • First born Full term (i.e. born no more than 3 weeks prematurely) With birth weight over 2.5 kg Being raised as monolingual English speakers

You may not qualify if:

  • Neither caregivers nor infants have any significant known physical, mental or learning disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sheffield

Sheffield, South Yorkshire, S10 2TN, United Kingdom

Location

Study Officials

  • Danielle E Matthews, PhD

    University of Sheffield

    PRINCIPAL INVESTIGATOR
  • Catherine Davies, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Cognitive Development

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 3, 2016

Study Start

August 10, 2016

Primary Completion

March 20, 2018

Study Completion

March 22, 2018

Last Updated

May 4, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Yes. IPD will be archived in accordance with the guidelines and protocol of the University of Sheffield, the UK Data Archive and the ESRC's Research Data Policy. With parents' permission, data will be made available in a timely manner, after outcomes have been published together with appropriate metadata in line with ESRC policy around data archiving.

Locations