Checklist for reporting an a randomised trial of a social or psychological intervention

Identification as a randomised trial in the title. Read more

Structured summary of trial design, methods, results, and conclusions. Refer to CONSORT extension for social and psychological intervention trial abstracts (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2735-z/tables/3). Read more

Scientific background and explanation of rationale. Read more

Specific objectives or hypothesis, If pre-specified, how the intervention was hypothesized to work. Read more

Description of trial design (such as parallel, factorial) including allocation ratio. If the unit of random assignment is not the individual, please refer to CONSORT for Cluster Randomised Trials (https://www.equator-network.org/reporting-guidelines/consort-cluster/). Read more

Important changes to methods after trial commencement (such as eligibility criteria), with reasons. Read more

Eligibility criteria for participants. When applicable, eligibility criteria for settings and those delivering the interventions. Read more

Settings and locations of intervention delivery and where the data were collected. Read more

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered. Read more

Extent to which interventions were actually delivered by providers and taken up by participants as planned. Read more

Where other informational materials about delivering the interventions can be accessed. Read more

When applicable, how intervention providers were assigned to each group. Read more

Completely defined pre-specified outcomes, including how and when they were assessed. Read more

Any changes to trial outcomes after the trial commenced, with reasons. Read more

How sample size was determined. Read more

When applicable, explanation of any interim analyses and stopping guidelines. Read more

Method used to generate the random allocation sequence. Read more

Type of randomization; details of any restriction (such as blocking and block size). Read more

Mechanism used to implement the random allocation sequence, describing any steps taken to conceal the sequence until interventions were assigned. Read more

Who generated the allocation sequence, who enrolled participants, and who assigned participants to interventions. Read more

Who was aware after assignment to interventions (for example, participants, providers, those assessing outcomes), and how any masking was done. Read more

If relevant, description of the similarity of interventions. Read more

Statistical methods used to compare group outcomes. How missing data were handled, with details of any imputation method. Read more

Methods for additional analyses, such as subgroup analyses, adjusted analyses, and process evaluations. Read more

For each group, the numbers randomly assigned, receiving intended treatment, and analysed for the outcomes. Where possible, the number approached, screened, and eligible prior to random assignment, with reasons for non-enrolment. Read more

For each group, losses and exclusions after randomization, together with reasons. Read more

Dates defining the periods of recruitment and follow-up. Read more

Why the trial ended or was stopped. Read more

A table showing baseline characteristics for each group. Include socioeconomic variables where applicable. Read more

For each group, number included in each analysis and whether the analysis was by original assigned groups. Read more

For each outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval). Indicate availability of trial data. Read more

For binary outcomes, presentation of both absolute and relative effect sizes is recommended. Read more

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory. Read more

All important harms or unintended effects in each group (For specific guidance see CONSORT for harms). Read more

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses. Read more

Generalisability (external validity, applicability) of the trial findings. Read more

Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence. Read more

Registration number and name of trial registry. Read more

Where the full trial protocol can be accessed, if available. Read more

Sources of funding and other support, role of funders. Declaration of any other potential interests. Read more

Any involvement of the intervention developer in the design, conduct, analysis, or reporting of the trial. Read more

Other stakeholder involvement in trial design, conduct, or analyses. Read more

Incentives offered as part of the trial. Read more