NCT02780557

Brief Summary

The aim of this project is to test whether giving parents advice about book reading is effective in promoting language learning for infants 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
156

participants targeted

Target at 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

May 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 24, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
2 months 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

1.4 years

First QC Date

May 19, 2016

Last Update Submit

May 1, 2018

Conditions

Keywords

VocabularyBook readingInfancyParenting

Outcome Measures

Primary Outcomes (1)

  • Change in infant expressive vocabulary

    Parents will complete a standardised assessment of vocabulary, the MacArthur-Bates Communicative Development Inventory (CDI).

    Baseline: 11 months, outcome: 15 months

Secondary Outcomes (3)

  • Change in caregiver reported frequency of reading

    Baseline: 11 months, outcome: 15 months

  • Infant Real Time Language Understanding: Accuracy

    15 months

  • Infant Real Time Language Understanding: Reaction Time

    15 months

Other Outcomes (1)

  • Change in caregiver contingent talk while book reading

    Baseline: 11 months, outcome: 15 months

Study Arms (2)

Contingent Reading Intervention

EXPERIMENTAL
Behavioral: Contingent Reading Intervention

Book Provision Control

OTHER
Behavioral: Book Provision Control

Interventions

Caregivers will be provided with 6 picture books. They will be trained to use contingent talk when looking at picture books with their infants. They will be asked to spend 10 mintues each day engaging in contingent talk while looking at picture books. The intervention will run for 4 months. Parents will be asked to keep a daily reading diary.

Contingent Reading Intervention

Caregivers will be provided with 6 picture books. They will not be trained to read with their child. They will receive information from other sources (e.g. health visitors and Book Start schemes) as normal.

Book Provision Control

Eligibility Criteria

Age11 Months - 11 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants must be:
  • first born and singletons
  • full term (i.e. born no more than 3 weeks prematurely)
  • with birth weight over 2.5 kg.
  • Primary caregivers must:
  • work less than 24 hours per week (i.e., be the caregiver the child spends most time with)
  • be raising their child as monolingual English speakers.

You may not qualify if:

  • Neither caregivers nor infants must 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

Study Design

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

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 23, 2016

Study Start

August 24, 2016

Primary Completion

January 30, 2018

Study Completion

March 22, 2018

Last Updated

May 4, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

With participants' permission, IPD will be archived in accordance with the guidelines of the University of Sheffield, the UK Data Archive and the ESRC's Research Data Policy.

Locations