Safeguarding in research: case study #1

Off

Investigating whether video materials help parents to support infant and toddler language development?

What was the research about?

Aims

To test a smart-phone based service for parents designed to help them support their children’s language skills before school entry. Early language delays associated with social disadvantage puts children at risk of entering a vicious cycle of educational inequality from the start of primary school. A promising new approach to preventing language delay is the nationwide delivery of digital parenting services that provides caregivers with specific developmental-stage-related strategies to scaffold language development plus video-call support. This study will test if this approach can promote caregiver-child interaction from early on, whether this benefits language learning, and, if so, which active ingredients cause these benefits

Participants

800 families will be recruited and assigned to either a language or control intervention when their child is 12 months old (infant group) or 30 months old (toddler group). The language intervention group will be sent short videos via text message three times a month on the topic of language development, with a text message follow-up. The control group will be sent short videos sent by text message three times a month on the topic of dental health, healthy eating, child health and safety, with a text message follow-up. All participants have the option to ask questions of a dentist and occupational therapist.

Outcomes

The primary outcome measure will be a composite language score derived from caregiver reports, standardised tests and naturalistic measures coded from recordings of free play at home. Language outcomes will be assessed one year later by collecting home videos and researchers will run standardised tests in participants’ homes. Post-intervention focus groups with caregivers and interviews with the Speech and Language Therapists will be carried out to identify potential barriers to implementation.

What were the safeguarding risks and mitigations?

Risks to the researcher:

Researchers will work alone to visit participants in their homes across the UK, and the risks are relatively low. Other than the risks involved in travelling, the main risk is feeling/being in danger if a family member behaves in a threatening manner. A bespoke home visit personal safety policy has been developed to mitigate this risk. The key feature of this policy is the buddy system - the researcher making the home visit has a fully charged phone and texts a nominated buddy when arriving at and leaving the family’s home they are visiting and upon arriving back at their base. If there is a difficulty with the phone signal outside the house they are visiting they drive to a location with a signal to let their team know they’ve arrived safely and there is a signal problem, with an estimate of when they will be able to call back. Unless an extended time frame is agreed, the buddy calls the researcher if they haven’t heard anything after 2 hours (max time for a home visit) and if no reply is received they contact the study project manager / PI. If there is no reason for the delay, the family being visited is contacted to ask them if the researcher left safely. If the researcher was still at the house they would be asked to call in. If they had left, then the time taken to return home would be allowed. If after this there is no explanation for the delay, then the police will be contacted. Another feature of the home visit safety policy is that the researcher is instructed that if they feel in danger they should leave the house immediately and should not feel the need to collect equipment before they do so.

Risks to the participants:

The risk of physical harm during data collection when a researcher visits homes is low as this involves running standardised language tests that are designed for use with young children and administered by a trained, DBS checked research assistant. They will be asked to sign a Behaviour Policy and asked to familiarise themselves with the study Safeguarding Policy and Home Visit Personal Safety Policy. No children will be encouraged to take part in a test if they express discomfort doing so. In terms of psychological distress, it is possible that some parents may feel concerned about their child’s language / physical development or their own wellbeing as a result of the activities. Risk will be limited by using video materials that have been quality controlled and measures that have been used before with families. Prior to beginning the study, parents will be provided with an information sheet which states that they should speak to their GP should they have any concerns regarding their own wellbeing or their child’s development. Once study participation has begun, the family facing team will ensure caregivers feel able to flag concerns and are listened to.

If a parent reports that they have experienced psychological distress as a consequence of taking part in the study, this will be reported to the PI and relevant team members who will agree on an appropriate response. In the event a serious concern is raised that cannot be

resolved, we will report this to the ethics committee to ensure further appropriate action is taken and future risk avoided. The participant will be asked what action that would like to see taken.

To ensure risks are identified and responded to promptly, the following schedule is planned:

Trial manager to email a weekly review to research team;
PI, Trial Manager and team members to meet weekly;
Wider research team to meet quarterly with ad hoc contact as necessary. Four advisory groups (impact, professional, parent and academic) to meet annually or biannually.

Parents will be informed that they can withdraw from the study at any time right up to the study’s completion without giving a reason. They will be given a written debrief and exit questionnaire after the final point of data collection.