Recruitment
School recruitment
We aim to recruit six primary/junior schools that vary in relation to: geographic area, size of school, percentage of pupils eligible for free school meals, percentage of pupils on special educational needs support, percentage of pupils with English as an additional language. We will disseminate information about the study via our existing networks and social media adverts and contact individual schools via email and follow-up telephone calls. To help ensure recruited schools have varied geographic and demographic characteristics, we will record characteristics of eligible schools that express an interest and target particular schools as needed.
Written consent for the school’s participation (online or on paper) will be obtained from school headteachers, and each school will be asked to nominate an iCATs-i2i lead to act as the primary point of contact for the study team and co-ordinate study procedures. Where schools have more than two Year 4 classes, we will select two classes to participate.
Participant recruitment
Study information will be distributed to all children, parents, and class teachers in participating classes. We will work with each school to develop strategies to distribute study information and promote participation (e.g. distributing paper, electronic and/or video versions of study adverts and study information, advertising the study in school newsletters/websites, sending reminders via email and SMS). Where COVID-19 government and school guidance allow, researchers will run information sessions for parents, children and school staff at the school, and where this is not possible we will offer to run online information sessions and/or provide school staff with materials to facilitate these sessions themselves.
Parents will be given the opportunity to opt their child out of the study, and the school iCATS-i2i lead will keep a record of these children’s names and no information or data will be collected about or from these children. With the exception of any children whose parent opts out, all children in participating classes, and their parents and class teachers will be invited to participate and complete baseline questionnaires. Prior to participating, written assent (on paper or online) will be obtained from children, and parents and class teachers will provide written consent (on paper or online) prior to completing baseline measures and/or providing any information or data themselves. Explicit consent for audio recording will be required prior to parent/school staff qualitative interviews, and both parental consent and child assent will be obtained prior to qualitative interviews with children.
Procedures
An overview of study procedures and assessments are provided in Figs. 1 and 2.
Where possible, researchers will visit schools to administer baseline questionnaires (online or on paper) with groups of children, and children will be able to choose to complete the questionnaires at home if they prefer. If COVID-19 government or school guidance prohibits researchers from visiting schools and/or schools are closed for all or some children, we will work with schools to adapt this procedure (e.g. school staff administer questionnaires with children at school, some or all children complete questionnaires at home).
After administering the child baseline questionnaires, we plan to facilitate a lesson on managing everyday fears and worries for participating classes. Our intention is for researchers to lead this lesson with school staff support, on the same day or soon after children complete baseline questionnaires. However, we will be flexible in how and when we use this lesson to accommodate school staff preferences and potential COVID-19 restrictions, and will offer alternatives as needed (e.g. we provide school staff with the lesson materials to deliver themselves at a suitable time, we adapt materials to deliver an online lesson).
After baseline questionnaires are collected from children, schools will distribute consent and questionnaires to parents/carers, either on paper and/or online. Parents will be provided with an envelope to return paper questionnaires to school, ready for collection by the study team. In parallel, we will ask class teachers to complete teacher-report questionnaires (online or on paper) about all children in their class (where parents did not opt-out) and we will provide the iCATS-i2i school lead with forms to complete demographic, attendance, punctuality and learning information about these children, and to keep a record of school staff time spent on iCATS-i2i activities.
Where baseline questionnaires for a child are completed by at least one reporter (child, teacher, parent), the parent/carer will receive a feedback letter. Where parents provided us with their contact details, we will send this letter to them directly by post, and where we do not have parent contact details, we will provide schools with the letter in a sealed envelope to give to the parent or send home with the child. If parents complete the baseline questionnaires, including the brief child anxiety screen, the letter will provide feedback on whether the responses indicate the child may be experiencing difficulties with anxiety (screen positive) or is unlikely to be experiencing difficulties with anxiety (screen negative). Where the child screens positive, the letter explains that the study team will be in touch to arrange a feedback telephone call with the study Children’s Wellbeing Practitioner to discuss their questionnaire responses and offer the family OSI. Where the child screens negative or where there is no screening outcome (because the parent did not complete the screening questionnaire), the letter explains that OSI is available to all families who feel they may benefit and parents are invited to get in touch with the study team if they wish to discuss this further. A brief description of OSI and overview of sessions will be included with all parent feedback letters. With parental consent, the study team will share screening outcomes with the school iCATS lead.
Researchers will contact parents of children who screen positive by email, SMS and/or telephone to arrange a convenient time for the feedback call. During the call, the CWP will invite parents to take part in OSI, and if parents agree, they will be given access to the online intervention and their telephone support sessions will be booked. If a parent who has not previously provided consent/completed parent-report baseline questionnaires contacts us following the feedback letter, and subsequently verbally agrees to take part in OSI, they will be asked to provide written consent and complete baseline questionnaires before starting the intervention. The CWP/s and their supervisor/s will complete a log throughout the intervention delivery, to record time spent on activities related to delivering and supervising OSI.
We will collect follow-up measures approximately 12-weeks after baseline questionnaires. As our primary aim is to assess the feasibility of collecting follow-up questionnaires and estimate retention rates, we will employ some flexibility with the exact timing of the follow-up assessment if COVID-19 restrictions/disruptions present particular barriers to timely data collection. Although a subsequent cluster randomised controlled trial would include follow-up assessments at 6, 12 and 24 months, retention rates immediately post-intervention and at 30-month follow-up were fairly similar in a recent primary school UK trial (19), and a shorter follow-up period will allow more timely progression to the main trial, if indicated.
All participants (children, parents, teachers) who complete baseline assessments will be asked to complete follow-up questionnaires. Follow-up questionnaires will be collected from children, and their parent and class teacher in parallel. Researchers will administer follow-up questionnaires (online or paper) with children at school, but we will adapt this procedure as needed in response to COVID-19 restrictions, as per at baseline. We will send parents and teachers personalised links to online follow-up questionnaires and/or provide the school iCATS-i2i lead with paper questionnaires to distribute to parents and teachers, together with envelopes to return to school for the study team to collect.
One-to-one interviews and/or discussion groups will be conducted with subgroups of children, parents, and school staff about their experiences of iCATS-i2i procedures during and after the intervention delivery phase. We anticipate that approximately 12 children and 12 parents will take part in an interview/discussion group, including children/parents where the child screened positive and screened negative, and those who took part in OSI and those who did not. We expect up to 10 members of school staff will take part in an interview/discussion group, and we will seek to include staff from each participating school, with varying roles (e.g. class teacher, iCATS-i2i lead, headteacher). Where appropriate, we will adopt further purposive sampling in order to learn from the experiences of participants who can offer a range of perspectives. For example, we will seek to include families where the child’s screening outcome may reflect a ‘false positive’ or ‘false negative’ by inviting parents/children where the anxiety screen score was just above and just below the cut-off. Interviews/discussion groups will be conducted either in-person at participating schools, by telephone or online video-call.
As a thank you, families will be offered a £10 gift voucher for each complete set of child/parent questionnaires and qualitative interview, and schools will be offered £200 for time spent on all study activities.
Data management
REDCap (Research Electronic Data Capture) databases will be used to capture data via online surveys and paper questionnaires directly inputted by researchers. Data captured will be held on University of Oxford servers and access will be restricted to the study team members. Once data collection is complete, data will be permanently deleted from REDCap and stored on a restricted access folder on the University of Oxford network.
Schools and participants will be assigned unique IDs, and these IDs will be used to label all study data. A document linking ID to names/contact information will be stored on a restricted access folder on the University of Oxford network. This linking document and other personally identifiable information (consent/assent, audio recordings) will be stored for as long as needed for research purposes and appropriate safeguards are in place, and then permanently deleted.
Pseudonymised study data will be shared with study statisticians and health economists for analysis, via the University of Oxford’s OneDriveforBusiness.