NCT04919343

Brief Summary

The aim of this project is to assess whether video materials from the BBC Tiny Happy People (THP) campaign are effective in terms of improving the language skills of socioeconomically disadvantaged children before they start school. This project will also look at how useable the service is for parents in terms of acceptability, effects on self-efficacy and implementation of advice.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
435

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 14, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

June 2, 2021

Last Update Submit

April 12, 2022

Conditions

Keywords

Vocabularysocioeconomic statusParentinglanguageparent-child interactionself-efficacyinfancy

Outcome Measures

Primary Outcomes (1)

  • 18 month expressive vocabulary

    Infant expressive vocabulary, assessed using the communicative development inventory (CDI) at 18 months

    2 months. Parents will complete the report within 2 months of the infant turning 18 months old.

Secondary Outcomes (3)

  • Caregiver responsive behaviour at 12, 18 and 24 months

    Measures will be collected within 2 months of the child turning 12, 18 and 24 months

  • Caregiver self-efficacy at 12, 18 and 24 months

    Measures will be collected within 2 months of the child turning 12, 18 and 24 months

  • 24 month expressive vocabulary

    3 months. Parents will complete the report within 3 months of the infant turning 24 months old.

Other Outcomes (1)

  • Intervention uptake - number of video links that were clicked on

    Clicking on a video link within one month of it being sent

Study Arms (2)

BBC Tiny Happy People intervention

EXPERIMENTAL

Parents will be sent links each month directing them to BBC Tiny Happy People content via SMS text message using the secure service FireText. This content will be aimed at supporting language development. Parents will be asked to watch the video content and incorporate it into their parenting practices. The intervention will start when infants are aged 4-9 months and conclude when they are 18 months with a follow up to 24 months where time permits.

Behavioral: BBC Education Tiny Happy People videos

Physical health control

ACTIVE COMPARATOR

Similar to the experimental condition, parents will be sent links each month via SMS text message using FireText. These links will direct them to publicly available web content with tips to promote the healthy development of their baby, focusing on things such as healthy eating, physical activities, and dental care. The intervention will start when infants are aged 4-9 months and conclude when they are 18 months with a follow up to 24 months where time permits

Behavioral: Physical health control intervention

Interventions

This intervention involves regular texting of BBC Education Tiny Happy People videos to parents

BBC Tiny Happy People intervention

This intervention involves regular texting of publicly available videos about supporting infant physical and dental health to parents

Physical health control

Eligibility Criteria

Age4 Months - 9 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Families must:
  • be raising their child as a monolingual English speaker (at least 80% of the language they hear in the home is English)
  • have a postcode in deciles 1-5 of the Office of National Statistics Index of Multiple Deprivation
  • have access to the internet and a device to watch videos (via smart phone)
  • Infants must:
  • be full term
  • have a healthy birthweight

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, S1 2LT, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Danielle 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

June 2, 2021

First Posted

June 9, 2021

Study Start

September 14, 2021

Primary Completion

November 30, 2022

Study Completion

May 31, 2023

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Anonymised Individual Participant Data will be archived using the Open Science Framework's repository. For those participants who give permission, video data will also be archived such that researchers who have signed a confidentiality agreement can access this data.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be made available at the same time as publication, anticipated within 2 years of study completion. It will remain available for at least 10 years.

Locations