Table 4 Protocol changes made since the trial commenced
Aspect of trial | Changes made |
|---|---|
Primary outcome point | Change from 3-months to 4-months. Due to family availability and referral rates, baseline interviews have been conducted over a longer time period than was anticipated. As a result, some families were being offered a 3-month follow-up appointment while still accessing the Young SMILES intervention (if randomised to that trial arm). To ensure the amount of ‘useful data’ is maximised, the primary outcome point was changed to 4 months, without altering the 6- and 12-month time points |
Data collection | Addition of demographic questionnaire for all participants taking part in the feasibility trial (children and young people, parents, carers) Addition of referrer interviews to explore the experiences of individuals who have referred to the study and also those who have been approached but have not referred any families; individuals will be from health, social care, educational and third sector services, which will aid a more thorough understanding of the development of referral pathways that will add to the other findings from the feasibility study to assist with the development of an application for a full-scale trial |
Randomisation | Change from using the Sealed Envelope system (www.sealedenvelope.com) to randomise 60 families on a 1:1 ratio either to Young SMILES or to usual care to online randomisation software (www.randomization.com), which would better meet study requirements in relation to sample size and the ability to stratify by age and site, without incurring costs Addition of 2:1 randomisation allocation procedures (2 Young SMILES intervention; 1 control) to expedite start of intervention groups; this has been acknowledged to be wholly appropriate for a feasibility trial in such a ‘specified group’ intervention |
Intervention delivery | Inclusion of siblings within the same group (if in the same age band) Submission of young person travel consent form for parents/carers to consent to child/adolescent travelling to the intervention venue alone |
Participant communication | Submission of letters/documents to communicate with families/sites during the trial, e.g. if unable to contact family or if any participant wishes to withdraw |