Table 3 Progression Criteria from Pragmatic Pilot to Main Trial
Criteria | Green | Amber | Red | |
|---|---|---|---|---|
Recruitment | How many parents consent and corresponding students assent (target n = 120) | 50% or above Continue with main trial | 30 and 49% Consult research team to advise on changes to recruitment plan | Below 30% The pilot study may need to be extended |
Participant Retainment | Student completion up until T2 in both arms | 70% or above Continue with main trial | 50–69% Consult research team to advise on changes to survey administration protocol | Below 50% The main trial will need to reconsider how surveys are administered |
Intervention Adherence | Number of students attending online lesson for the full duration (supplemented with qualitative feedback on online delivery of lesson) | 90% or above Continue with main trial | 70–89% Consult research team to advise on changes to lesson delivery | Below 70% The main trial will need to reconsider how lesson is delivered |
Fidelity of Lesson Delivery | Percentage of the lesson covered by teacher, assessed by two fidelity checkers | 90% or above Continue with main trial | 60–89% Consult research team on possible changes to lesson intervention or training | Below 60% Fully reconsider lesson intervention/training |