Table 1 Stop-go progression criteria
Criteria | Green | Amber | Red | ||
|---|---|---|---|---|---|
1. Feasibility assessment | |||||
Participant recruitment | How many participants showed up at T1? | More than 80% Continue to main trial | Between 60鈥�80% Consult research team and review recruitment plans | Less than 60% Pilot study may need to be extended | |
Participant retention at T3 | How many participants showed up at T3? | More than 80% Continue to main trial | Between 50鈥�80% Consult research team and discuss strategies to increase retention | Less than 50% The main trial will need to reconsider the inclusion of T3 | |
Ceiling and/or floor effects on the primary outcome | Is there evidence of ceiling or floor effects at T1 on the primary outcome measure, child body appreciation? | No Continue to main trial | Partial Consult research team and discuss potential measure amendments | Yes The main trial will need to potentially reconsider the response scale for the primary outcome | |
2. Harm assessment | |||||
Child distress | Were any of the children visibility distressed?, did any of the children tell the moderators anything concerning?, did any parent withdraw their child during the pilot due to the content or research process? | None Continue to main trial | Between 1鈥�10% Review feedback from moderators and parents, consult with the research team | More than 10% All cases to be qualitatively investigated and the team to consider the safety of the trial | |