Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04919343
Other study ID # 165718
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 14, 2021
Est. completion date May 31, 2023

Study information

Verified date April 2022
Source University of Sheffield
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The current study will evaluate BBC Education's Tiny Happy People initiative (https://www.bbc.co.uk/tiny-happy-people) which seeks to reduce the impact of social and economic disadvantage on children's language skills before they arrive at primary school. BBC Education have created videos for parents and other caregivers with information about child development, tips and activities as well as other content of interest. The aim of the evaluation is to find out how parents feel about the materials and whether the videos promote a) caregiver confidence at 12, 18 and 24 months, b) caregiver-infant interaction at 12, 18 and 24 months and c) child language at 18 and 24 months. The primary outcome is expressive vocabulary size at 17-18 months. Families with 4- to 9-month-old infants who would like to take part will be randomly allocated either to a language support group or a physical health active control group and sent short, age-appropriate advice videos by text message three times a month until their children are 18 months old (with follow up videos for children until the age of 2 years where possible given study time limits).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 435
Est. completion date May 31, 2023
Est. primary completion date November 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Months to 9 Months
Eligibility Inclusion Criteria: 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 Exclusion Criteria: Neither caregivers nor infants must have any significant known physical, mental or learning disability

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BBC Education Tiny Happy People videos
This intervention involves regular texting of BBC Education Tiny Happy People videos to parents
Physical health control intervention
This intervention involves regular texting of publicly available videos about supporting infant physical and dental health to parents

Locations

Country Name City State
United Kingdom University of Sheffield Sheffield South Yorkshire

Sponsors (4)

Lead Sponsor Collaborator
University of Sheffield University of Liverpool, University of Manchester, University of Melbourne

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Intervention uptake - number of video links that were clicked on Parents will be sent regular text messages with links to videos with information about supporting child language or physical health. We will take % of links clicked as a fidelity measure. We will check whether parents were more likely to click though to these links in one condition or the other and run a Complier Average Causal Effect analysis. Clicking on a video link within one month of it being sent
Primary 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 Caregiver responsive behaviour at 12, 18 and 24 months Parents willing and able to upload a 5-minute video of a play time with their child will have the option to do so. A researcher will code the video using the PaRRis rating scale. Measures will be collected within 2 months of the child turning 12, 18 and 24 months
Secondary Caregiver self-efficacy at 12, 18 and 24 months Parents will be sent a self-efficacy questionnaire to complete in the format of a qualtrics survey, via SMS text message at each time point. Questions will focus on how parents feel about their parenting in general and supporting their child's language development and physical health. Measures will be collected within 2 months of the child turning 12, 18 and 24 months
Secondary 24 month expressive vocabulary Infant expressive vocabulary, assessed using the communicative development inventory (CDI) at 24 months 3 months. Parents will complete the report within 3 months of the infant turning 24 months old.
See also
  Status Clinical Trial Phase
Completed NCT03268928 - Evaluating the Impact of Story Starters on Children's Language Development N/A
Recruiting NCT06026124 - Retrieval-Based Word Learning in Developmental Language Disorder During Book Reading N/A
Completed NCT02853786 - Language Environment in Children With Cochlear Implants N/A
Recruiting NCT02998164 - Improving Outcomes Using Technology for Children Who Are DHH N/A
Recruiting NCT04857255 - Technology-assisted Language Intervention (TALI) N/A
Active, not recruiting NCT04609553 - Literacy Promotion for Latinos Study N/A
Active, not recruiting NCT05339464 - Ready and Healthy for Kindergarten N/A
Completed NCT03795454 - Can Singing Kangaroo Improve Outcome of Preterm Infants N/A
Completed NCT03076268 - TMP-Visitas al Hogar N/A
Active, not recruiting NCT05325333 - Retrieval-Based Word Learning in Developmental Language Disorder N/A
Recruiting NCT06125093 - Study of an Early Parenting Intervention for Children With Genetic Abnormalities and Mental Health Problems N/A
Recruiting NCT06261307 - Language Development Deficits and Early Interactive Music Intervention N/A
Completed NCT06001866 - Retrieval-Based Word Learning in Developmental Language Disorder: Verb Learning N/A
Completed NCT03766906 - STEM (Science, Technology, Engineering & Math) Familia Talk N/A
Active, not recruiting NCT05508282 - Testing an App-Based Approach to Reading and Screen Time Guidance for Parents of Infants N/A
Completed NCT04027673 - Thirty Million Words-Early Childhood Educator (TMW-ECE) N/A
Completed NCT04423133 - Bilingual Family Literacy Program Pilot N/A
Not yet recruiting NCT05861531 - Learning to Talk, Learning to Eat: A Randomized Controlled Trial to Improve NICU Oral Feeding and Language Outcomes N/A
Completed NCT02774356 - Testing Native Language Neural Commitment at the Subcortical Level N/A
Completed NCT03547492 - Developmental Intervention for Infants of Adolescent Mothers N/A