Do Video Materials Help Parents to Support Infant Development?

April 12, 2022 updated by: Danielle Matthews, University of Sheffield

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
435

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S1 2LT
        • University of Sheffield

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 months to 9 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BBC Tiny Happy People intervention
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
This intervention involves regular texting of BBC Education Tiny Happy People videos to parents
Active Comparator: Physical health control
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
This intervention involves regular texting of publicly available videos about supporting infant physical and dental health to parents

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 months. Parents will complete the report within 2 months of the infant turning 18 months old.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
24 month expressive vocabulary
Time Frame: 3 months. Parents will complete the report within 3 months of the infant turning 24 months old.
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.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intervention uptake - number of video links that were clicked on
Time Frame: Clicking on a video link within one month of it being sent
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sheffield

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Liverpool
University of Manchester
University of Melbourne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Danielle Matthews, PhD, University of Sheffield

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 165718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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