Session 3: Trial management Sarah Miller (Queens, Belfast) Laura Dunne (Queens, Belfast)

1. Session 3: Trial managementSarah Miller (Queens, Belfast) Laura Dunne (Queens, Belfast)

2. RCT management: key issues and lessons learned… Dr Laura Dunne & Dr Sarah Miller

3. Introduction: “An ounce of prevention is worth a pound of cure” Related issues: • Recruitment • achieving required sample and power • Retention • Treatment attrition • Measurement attrition • Communicating with schools and developers

4. Two examples… • RCT evaluation of Barnardo’s Ready To Learn afterschool programme: 16 schools and 8 data collection sweeps over three years • RCT evaluation of a classroom based social emotional learning programme: 74 schools and 5 data collection sweeps over four years

5. RCT Evaluation of Barnardo’s Ready To Learn Afterschool Programme The programme: • Aims to raise achievement by focusing on children’s early literacy skills and enhance parental engagement in children’s learning • Programme runs during term time for one hour after school on Tuesday, Wednesday and Thursday afternoons • Activities in the programme include story telling, drawing, singing, puppets, talking and listening

6. RCT Evaluation of Barnardo’s Ready To Learn Afterschool Programme The evaluation: • A cluster randomised design combining outcome data with experiences of participants (over three years, 8 data sweeps) • 16 schools, 564 Year 1 pupils (9 intervention; 7 control) Measures • Battery of age-appropriate tests , focus groups and parental interviews • Principal interviews

7. RCT evaluation of the Roots of Empathy programme The Programme: • A universal programme delivered on a whole-class basis for one academic year • 27 lessons based around 9 themes delivered by a trained RoE instructor • Lessons revolve around a monthly classroom visit by an infant and parent • The parent-infant visit serves as a springboard for discussions about understanding feelings and infant development and effective parenting practices

8. RCT evaluation of the Roots of Empathy programme The Evaluation: • Cluster randomized controlled trial: 74 primary schools randomly allocated to control and intervention groups • Schools in the intervention group receive the programme in their selected Year 5 class for one academic year • Schools in the control group do not receive the programme but receive it the following year

9. Key issues School recruitment • Actively engage with schools re: both the programme and the methodology e.g. attend information sessions, meetings with service and Principals. • Make it clear to schools what their participation will involve (MoU) • Meetings with service and Principals • Consider a wait list control • Financially compensate for teacher time • Consent prior to randomisation

10. Key issues Retention • Regular communication: newsletters each term, study updates, Christmas cards, annual principal interviews, school visits • Minimise disruption and be flexible - pilot measures, testing P1-3, stickers • Document reasons for dropout and monitor attrition between intervention and control groups • If a school drops out of the intervention, continue to collect data (ITT) • Process evaluation: observation and field notes

11. Key issues Communication • Make clear to schools who in which team is responsible for each element of the study (MoU), provide a timetable of events • Identify a key contact to liaise with in the school • Minimise the number of different people the school has to deal with • Agree a research plan and be clear who is responsible for what • Regular (and efficient) communication between programme developer(s) and research team (Skype, email etc) • Set realistic expectations of the possible outcomes of the evaluation