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Clinical Trials/ISRCTN45990335
ISRCTN45990335
Active, not recruiting
未知

Evaluating a text-message service that delivers BBC Education Tiny Happy People early language resources to families with infants and toddlers: a randomised controlled trial

University of Sheffield0 sites803 target enrollmentSeptember 19, 2024

Overview

Phase
未知
Intervention
Not specified
Conditions
Language development in early childhood (0 to 4 years) in socioeconomically diverse children, and linguistic responsiveness on the part of their caregivers
Sponsor
University of Sheffield
Enrollment
803
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 19, 2024
End Date
January 31, 2026
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • In order to be invited to take part, the child must meet the following criteria:
  • Infant group, date of birth between 1st February 2023 - 18th November 2023 (i.e.,10-20 months on 17th September)1.
  • Toddler group, date of birth between 3rd August 2021 - 15th May 2022 (i.e. 28-38 months on 17th September)
  • Birth weight must not be below 2.5 kg (5 lb 8 oz)
  • Must not have been born more than 3 weeks premature (full term is 37-42 weeks - anything 36+6 or earlier is preterm)
  • Child hears English spoken in the home at least 50% of the time
  • Postcode must have an Index of Multiple Deprivation (IMD) of 1-5 or country equivalent
  • Must not have any known significant disability themselves, or on the part of their parent, that would significantly affect language development (decided before randomisation)Families must have access to the internet and a device to watch videos (via smartphone, tablet or computer/laptop).In order to be offered follow-up calls with an SLT, families must meet one of the following criteria:
  • Baseline score on the communication subset of the ASQ that falls within the grey (monitoring zone, 1-2 SD from mean) or black zone (at risk, 2+ SD from mean)
  • PaRRiS score below 3 (if volunteering to send home video)

Exclusion Criteria

  • Caregiver or infant had a condition known to affect child language development at the point of recruitment
  • Child did not hear English at home more than 50% of the time
  • Child premature or low birth weight
  • Family IMD 6 or aboveNB. Children may receive a diagnosis of a medical condition after the study starts and they will remain in the study even if this is the case.

Outcomes

Primary Outcomes

Not specified

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