Mejia‐Downs 2016.
| Study characteristics | ||
| Methods |
Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power sample size calculation, level of power achieved): not specified Imputation of missing data: imputation of missing data not specified; all randomised participants were analysed (n = 43) |
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| Participants |
Country: USA Setting: university Age: adults (see Population description; age not specified) Sample size (randomised): 43 Sex: not specified Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: perceived stress (PSS‐10): IG: 13.59 (5.01), CG: 13.90 (4.56) Population description: health professional students/doctor of physical therapy students Inclusion criteria: current enrolment in Doctor of Physical Therapy programme at either Indiana University or the University of Indianapolis Exclusion criteria: no exclusion criteria specified Attrition (withdrawals and exclusions): not specified Reasons for missing data: not specified |
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| Interventions |
Intervention: resilience curriculum (n = 22)
Control: wait‐list control (n = 21) |
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| Outcomes |
Outcomes collected and reported: Primary outcome
Secondary outcome
Other outcome
Time points measured and reported: 1) pre‐intervention (in first 2 weeks of semester); 2) 2‐week follow‐up (4‐week intervention after 2‐week pre‐intervention assessment; follow‐up at week 8 after baseline, i.e. 2 weeks post‐intervention) Adverse events: not specified |
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| Notes |
Contact with authors: We contacted authors for the summary outcome data for the outcomes (Mejia‐Downs 2018 [pers comm]). Study start/end date: see trial registration: September 2015 – January 2016 Funding source: University of Indianapolis Declaration of interest: not specified Ethical approval needed/obtained for study: not specified Comments by authors: register number: NCT02541240 Miscellaneous outcomes by the review authors: dissertation; information received from authors: study completed but not yet published; result tables for RCT provided from published dissertation Correspondence: principal investigator: Anne M Mejia‐Downs, PT, MPH; University of Indianapolis; adowns@uindy.edu |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote (see trial registration): "The study involves curriculum development and evaluation by randomized controlled trial. Participants will be randomized to the intervention group to receive a Resilience Curriculum or to a wait‐list control group" Judgement comment: insufficient information about random‐sequence generation (in trial registration and results sent from authors) to permit judgement of 'Low risk' or 'high risk'; no significant baseline differences between groups in resilience and positive affect, not described for other variables |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: insufficient information (in trial registration and results sent from authors) about allocation concealment to permit judgement of 'Low risk' or 'high risk' |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Judgement comment: blinding of participants and personnel probably not done (face‐to‐face intervention), and the outcome is likely to be related to true outcome |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Judgement comment: insufficient information about blinding of outcome assessment (in trial registration and results sent from authors); but due to potential performance bias (no blinding of participants), the review authors judge that the participants' responses to questionnaires may be affected by the lack of blinding (i.e. knowledge and beliefs about intervention they received) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: results sent from authors; all 43 randomised participants were analysed; but unclear if there were any missing data that were imputed |
| Selective reporting (reporting bias) | Low risk | Judgement comment: trial registration (NCT02541240) available and all of the study’s prespecified (primary and secondary) outcomes that are of interest in the review have been reported in the prespecified way |