Table 2 Study outcomes, indicators, and means of verification
Outcome | Indicator(s) for progression to definitive trial | Means of verification | Participants assessed | Time points | |||
|---|---|---|---|---|---|---|---|
Screening/baseline | Intervention (5 weeks) | Post-intervention | 5-week follow-up | ||||
Appropriateness | Eligibility: > 50% of persons are screened are eligible | Routine study monitoring forms | Screened individuals | X | |||
Sensitivity to change: Small to moderate within-group changes in outcome measures (d > 0.2) | Brief-COPE, K-6, OSS, PWI, WHODAS | Participants | X | X | X | ||
Intervention fidelity: > 75% fidelity to the intervention elements | Fidelity assessmenta | Facilitator pairs | X | ||||
Stakeholder perspectives: Participants and facilitators report that the intervention and research procedures are appropriate and relevant to the needs of host and migrant women | Qualitative interviews | Participants, facilitators | X | X | |||
Acceptability | Intervention engagement and completion: > 85% of participants attend first session; > 67% participants complete at least 4 sessions | Routine study monitoring forms | Participants | X | |||
Intervention usability: Facilitators consider the intervention to have above average usability (IUS Score > 68). | Intervention Usability Scale | Facilitators | X | ||||
Stakeholder perspectives: Participants and facilitators report that the intervention and research procedures are acceptable and safe for host and migrant women | Qualitative interviews | Participants, facilitators | X | X | |||
Feasibility | Recruitment rate: Average rate of enrollment is 5 women per week, at minimum, in each community | Routine study monitoring forms | Participants | X | |||
Randomization: No moderate to large differences (d > 0.5; Φ > 0.3) in baseline characteristics between study conditions within study sites | Demographics, Brief-COPE, K-6, OSS, PWI, WHODAS | Participants | X | ||||
Attrition: > 80% of participants complete baseline, post-intervention, and follow-up assessments | Demographics, Brief-COPE, K-6, OSS, PWI, WHODAS | Participants | X | X | X | ||
Fidelity to research procedures: No major protocol deviations | Routine study monitoring forms | Research assistants | X | X | X | X | |
Facilitator competencies: An average score of > 2 on competency items, suggesting partially-fully demonstrating the competencies during intervention implementation | ENACTa | Facilitators | X | ||||
Contamination: Stress management components from the experimental conditions are included in all sessions for groups randomized to the enhanced intervention and none of the sessions for groups randomized to the standard intervention | Fidelity assessmenta | Facilitator pairs | X | ||||
Performance of outcome measures: All outcome measures display adequate construct validity and internal consistency | Brief-COPE, K-6, OSS, PWI, WHODAS | Participants | X | X | X | ||
Stakeholder perspectives: Participants and facilitators report that the intervention and research procedures are feasible, adoptable, scalable, and sustainable. Participants and facilitators identify barriers and facilitators to implementation as well as strategies for overcoming/leveraging these factors. | Qualitative interviews | Participants, facilitators | X | X | |||
Safety | Adverse events: Detected in < 10% of participants; no serious adverse events attributed to study participation | Adverse event reporting | Participants | X | X | X | X |
Stakeholder perspectives: Participants and facilitators report that the intervention and research procedures are acceptable and safe for host and migrant women | Qualitative interviews | Participants, facilitators | X | X | |||