Go/No-Go Decision Protocol
Objective: Determine whether TNAT-38 can proceed as the primary outcome for planned downstream randomized controlled trials evaluating caregiver training interventions, based on pre-specified validation criteria.
Decision Committee composition: E3 (Psychometrics Lead, Mei-Ling Chen); E6 (Trial Methodology Lead, Anders Bjork-Eriksson); Principal Investigator; Lead Statistician; 3 of 4 quorum required; 2/3 majority for approval
- CFA fit: RMSEA \<0.06, CFI ≥0.95, TLI ≥0.95, SRMR \<0.05
- Factor loadings: All λ ≥0.40; <2 items with cross-loadings >0.30
- Measurement invariance: Scalar for Language (ΔCFI ≤0.01); Scalar for Type (ΔCFI ≤0.015); Metric for Context (ΔCFI ≤0.01); \<2 items total non-invariant
- DIF: No items statistically significant by literacy (FDR q ≥0.05); ≤2 items meaningful DIF by type
- Convergent validity: TNAT-38 competency–CSES-10 r ≥0.40
- Test-retest: ICC ≥0.75 total, ≥0.70 per domain
- Decision: Approve TNAT-38 as primary outcome; proceed immediately to RCT recruitment
- CFA fit: 0.06 ≤ RMSEA ≤0.08, 0.90 ≤ CFI \<0.95, SRMR \<0.08; acceptable range but not optimal
- OR: Good fit on some indices, acceptable on 1–2 others
- Factor loadings: 1–3 items \<0.40; ≤3 items cross-loadings \>0.30
- Measurement invariance: Partial invariance requiring context-specific interpretation (3–4 items non-invariant per domain)
- Decision: Require minor item revision (wording clarification, threshold adjustment); conduct targeted re-validation (n=50–75), confirming revision efficacy before RCT launch; conditional approval with 3-month timeline extension
- CFA fit: RMSEA \>0.08, CFI \<0.90, or multiple indices poor fit
- Factor loadings: \>3 items \<0.40; substantial cross-loadings
- Measurement invariance: Fundamental non-invariance (\>4 items per domain non-invariant); differential interpretation across types suggesting domain restructuring needed
- DIF: Multiple items (\>3 per domain) with substantial meaningful DIF
- Decision: Do not approve as primary outcome; recommend either: (a) restructure instrument (merge/remove domains); (b) revert to secondary outcome (TNAT-38 as exploratory); (c) employ alternative primary outcome (supervisor rating, skills checklist) with RCT timeline extension for selection/validation
- Primary CFA acceptable, but invariance/DIF concerns suggest domain-specific rather than pooled scoring
- Decision: Approve TNAT-38 for RCTs BUT with mandatory stratified analysis by caregiver type; domain-specific scoring; sensitivity analyses comparing pooled vs. stratified results; downstream trial methods pre-register stratified approach
Success Criteria: GREEN or AMBER status achieved; formal sign-off from all 4 voting committee members; decision documented in Research Notes