Table 4 Overview of the TRAIN intervention and resources

Unit 1: The trial protocol (50 min)

  1.1 Introduction (10 min)

- Welcome & Introduction

1.1 Introduction (presentation slides)

  1.2 The trial protocol (15 min)

- Aim/importance of the trial

- Eligibility criteria

- What taking part will involve including potential harms and benefits of the study

1.2 Trial Protocol (presentation)

  1.3 Recruitment pathway (10 min)

- An exercise asking participants to map out the host trial pathway to assess their understanding of the information from 1.2 Trial Protocol

1.3 Recruitment Pathway exercise

1.3 Infographic (diagram summarising the protocol)

  1.4 Challenging questions (10 min)

- Discussion on issues/challenging questions parents may have beyond the protocol information and how one might address these

1.4 Challenging Questions

  1.5 Close (5 min)

- Questions/comments

Unit 2: Understanding randomisation (5 min)

  2.1 Randomisation (5 min)

- A video explaining the process of randomisation to assist recruiters in explaining the process to parents of neonates who are being invited to take part in a trial

2.1 Randomisation Video

Unit 3 Approaching and engaging with parents (70 min)

  3.1 Approaching parents (30 min)

- Critical considerations for recruiters before approaching parents about the possibility of their neonate being involved in a trial

3.1 Approaching parents

3.1 Infographic

3.1 Parent video vignettes

3.1 Lanyard

  3.2 Engaging with parents^a (15 min)

- A template recruitment conversation and order of topics with examples of opening sentences

3.2 Engaging with parents

3.2 Recruitment conversation guide

  3.3 Practicing recruitment (20 min)

- Roleplay session to work through challenging recruitment scenarios, with examples specific to neonatal trials. With feedback

3.3 Practicing recruitment

  3.4 Close (5 min)

- Final questions/comments