Methodological issues | Commentsa | Feasibility dataa | Criteriab | Feasible? (Y/N) | Need to modify pre-RCT? (Y/N) |
---|---|---|---|---|---|
1.Was the Family Navigation intervention acceptable to children and caregivers based on the 7 domains from the Theoretical Framework of Acceptability (TFA), including: a. Affective attitude b. Burden c. Perceived effectiveness d. Ethicality e. Intervention coherence f. Opportunity costs g. Self-efficacy | (e.g., data from 1-on-1 interviews) | (e.g., data will be analyzed using thematic analysis, which precludes quantification; 7 themes, plus additional sub-themes) | For each of the 7 domains, findings will be reviewed, discussed, and interpreted with our Stakeholder Committee and research team to determine whether parts of the Family Navigation intervention should remain unchanged or if changes are needed before implementing in our definitive RCT | (e.g., “yes” for all 7 domains) | (e.g., “yes” for 1 domain; “no” for 6 domains) |
2.What proportion of participants approached were eligible? | ≥ 90% approached were eligible | ||||
3.Did recruited participants complete consent/assent procedures? | ≥ 95% recruited participants completed consent/assent procedures | ||||
4.Did recruitment lead to successful enrollment? | 100% sample size goal achieved | ||||
5.Did participants agree to randomization? | ≥ 95% participants agreed to be randomized | ||||
6.Did randomization yield equality across groups? | Equal numbers of participants randomized to experimental and control groups | ||||
7.Were blinding procedures effective? | 100% analysts remained blinded to group assignment | ||||
8.Were outcome assessments completed? | ≥ 95% participants retained in the study completed outcome assessments | ||||
9.How complete were outcome assessments at all study measurement intervals? | ≥ 95% outcome assessments were complete | ||||
10. Were outcome assessments burdensome for families? | ≥ 90% children and caregivers disagreed that outcome assessments were burdensome | ||||
11. Was study protocol acceptable to children and caregivers? | ≥ 90% children and caregivers agreed study protocol was acceptable | ||||
12. Was the level of attrition adequate within experimental (Family Navigation + Usual Care) and control (Usual Care only) groups at 12 months? | Experimental (FN + UC): 15–25% attrition Control (UC): 30–40% attrition | ||||
13. Was collection of attrition data adequate to calculate sample size for definitive RCT? | ≥ 95% participants had attrition data collected by 12 months post-baseline | ||||
14. Were logistics of running a multi-center trial assessed? | Review procedures (ongoing and end-of-grant) with investigators, research staff, navigators | ||||
15. Did all components of the protocol work together adequately? | Review procedures (ongoing and end-of-grant) with investigators, research staff, navigators |