Language DevelopmentNCT04919343
Do Video Materials Help Parents to Support Infant Development?
A study testing BBC Education Tiny Happy People videos in people with Language Development, run by University of Sheffield at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 4 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Development
- What is being tested?
- BBC Education Tiny Happy People videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Neither caregivers nor infants must have any significant known physical, mental or learning disability
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Sheffield
Sheffield, South Yorkshire, S1 2LT
About this study
Official title: A Randomised Controlled Trial to Evaluate the Efficacy of BBC Education's Tiny Happy People Content in Supporting Infant Language Development.
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.
Read the detailed 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).
- Conditions
- Language Development
- Being tested
- BBC Education Tiny Happy People videos, Physical health control intervention
- Keywords
- Vocabulary, socioeconomic status, Parenting, language, parent-child interaction, self-efficacy, infancy
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBC Education Tiny Happy People videosBehavioural
This intervention involves regular texting of BBC Education Tiny Happy People videos to parents
Physical health control interventionBehavioural
This intervention involves regular texting of publicly available videos about supporting infant physical and dental health to parents
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Physical health control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
18 month expressive vocabulary
Infant expressive vocabulary, assessed using the communicative development inventory (CDI) at 18 months
Measured: 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
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.
Measured: 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
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.
Measured: Measures will be collected within 2 months of the child turning 12, 18 and 24 months
24 month expressive vocabulary
Infant expressive vocabulary, assessed using the communicative development inventory (CDI) at 24 months
Measured: 3 months. Parents will complete the report within 3 months of the infant turning 24 months old.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start14 Sep 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, University of Manchester, University of Melbourne
- Responsible party
- Principal investigator, Danielle Matthews, University of Sheffield
- Investigators
- Danielle Matthews, PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919343
- Sponsor's protocol ID
- 165718
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Evaluate the Efficacy of BBC Education's Tiny Happy People Content in Supporting Infant Language Development.
- ClinicalTrials.gov ID
- NCT04919343
- Acronym / sponsor ID
- 165718
- Conditions
- Language Development
- Keywords
- Vocabulary, socioeconomic status, Parenting, language, parent-child interaction, self-efficacy, infancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 435 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- University of Liverpool, University of Manchester, University of Melbourne
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBC Tiny Happy People intervention | Experimental | Behavioral: BBC Education Tiny Happy People videosParents 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. |
| Physical health control | Active comparator | Behavioral: Physical health control interventionSimilar 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 |
Who may qualify
- Ages
- 4 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
- be full term
- have a healthy birthweight
Key exclusion criteria (1 listed)
- Neither caregivers nor infants must have any significant known physical, mental or learning disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBC Education Tiny Happy People videosThis intervention involves regular texting of BBC Education Tiny Happy People videos to parents | Behavioural | BBC Tiny Happy People intervention |
| Physical health control interventionThis intervention involves regular texting of publicly available videos about supporting infant physical and dental health to parents | Behavioural | Physical health control |
Primary outcome
18 month expressive vocabulary
Time frame: 2 months. Parents will complete the report within 2 months of the infant turning 18 months old.
Infant expressive vocabulary, assessed using the communicative development inventory (CDI) at 18 months
3 secondary outcomes
Caregiver responsive behaviour at 12, 18 and 24 months
Time frame: 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
Time frame: Measures will be collected within 2 months of the child turning 12, 18 and 24 months
24 month expressive vocabulary
Time frame: 3 months. Parents will complete the report within 3 months of the infant turning 24 months old.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Website hosting content for parents in language intervention armLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Matthews, PhD principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BBC Education Tiny Happy People videos in people with Language Development, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18 month expressive vocabulary (time frame: 2 months. Parents will complete the report within 2 months of the infant turning 18 months old.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.