Research Design Consultant — Small-N Feasibility Pilot, Grief Intervention with First Responders

Project overview: Hypmthr LLC is finalizing the protocol for a 12-session feasibility pilot testing a communal cooking-based grief intervention with a first-responder population (EMS/fire/police). Target sample is 8–12 participants. Target publication venue is Pilot and Feasibility Studies (BMC/Springer). I need a research consultant to stress-test and finalize the protocol before it goes to IRB. Where the study currently stands: • Intervention: 12-session communal cooking program functioning as a grief-witnessing ritual • Outcome measures: cardiometabolic biomarker panel (hs-CRP, cortisol, fasting glucose/HbA1c) paired with the Witnessing of Disenfranchised Grief Scale (WDG; St Clair, 2013) — chosen because the population's grief isn't uniformly death-anchored (occupational/cumulative exposure, moral injury, loss of safety are also present) • Draft progression criteria exist in traffic-light format (recruitment, retention, data completion, acceptability, safety/distress) but need real thresholds tied to the actual recruitment pipeline, not placeholder benchmarks pulled from unrelated pilot studies • IRB route not yet finalized (commercial/independent IRB vs. academic affiliation) What I need help with: • Sample size & statistics — what's defensible to report at N=8–12; how to analyze the relationship between WDG change and biomarker change specifically, since that correlation is the actual claim the study wants to make • Progression criteria — sanity-check and finalize the thresholds against CONSORT extension guidance for pilot/feasibility trials • Outcome measure validation — WDG was validated on a death/miscarriage-loss sample and cross-sectionally, not as a pre/post change measure; needs an opinion on whether it holds up as-is for this population and use case, or needs adaptation/pairing with a second instrument • Ethics & safety protocol — consent language and a referral/safety protocol for a population being asked about grief and moral injury, including what happens if a session surfaces real distress • Overall protocol review — a second set of expert eyes on the full design before IRB submission and before this becomes a submitted manuscript Deliverable: Written protocol review/recommendation memo, plus availability for 1–2 follow-up calls to work through open questions together. Ideal background: • Doctoral-level training in thanatology, bereavement research, biostatistics, or public health research methods • Experience with pilot/feasibility trial design specifically (not just RCTs generally) — familiarity with CONSORT extension for pilot trials is a strong plus • Familiarity with disenfranchised grief literature and/or first-responder/occupational trauma populations • Must have direct experience preparing protocols for a US IRB (academic or commercial, e.g. Advarra/WCG) — please describe a study where you did this.