Table 2 Overview of feasibility and acceptability outcomes and progression criteria
Outcome | Evaluation | Progression criteria to controlled triala |
|---|---|---|
Feasibility of recruitment | • Numbers screened, number of eligible participants, number invited to participate, consent rates (for parents and adolescents), refusal rates and reasons for refusal | • Enrolment of at least 5 participants per week |
Appropriateness of data collection processes and outcome measures | • Number of missing items and follow-up rates | • Less than 15% missing items for each measure |
Retention in the ASPIRE intervention | • Number of participants who completed at least three sessions | • At least 70% of participants complete the counselling programme |
Counsellor competencies in delivering the ASPIRE intervention | • Scores on a counsellor competency checklist | • 75% competency |
Feasibility of randomization | • Number of consent/assent • Number of refusals to be randomized | • At least 80% participation |
Feasibility of blinding | • Field staff perceived contamination | • Very minimal perceived contamination (less than 5%) |
Presence of adverse events | • Number of study-related adverse events reported | • Less than 10% of participants reporting severe adverse events related to the study |
Acceptability of the ASPIRE intervention | • Qualitative interviews with participants and counsellors following the feasibility trial | • Not applicable |
|  | • Scores on the Child Evaluation Inventory (CEI) used to assess participants’ satisfaction with the intervention and how it was delivered | • More than 80% of participants scored a total of 60 or more on the CEI |
Acceptability of the study design and procedures | • Participants will be asked to rate the acceptability of the study procedures, including (i) screening, (ii) consent, (iii) assessment (length, type of questions, mode of administration), (iv) randomization, (v) referrals (and uptake of referrals), and (vi) tracking for follow-up assessments. They will rate these items on a 5-point scale (from 1 = not at all acceptable to 5 = very acceptable). | • More than 80% of participants score 3 or more for each rating |