1a. Title

Identification as a randomised trial in the title

Rosen D, Engel R, McCall J, Greenhouse J. Using problem-solving therapy to reduce depressive symptom severity among older adult methadone clients: A randomized clinical trial. Research on Social Work Practice. 2017.

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Snyder F, Flay B, Vuchinich S, et al. Impact of a social-emotional and character development program on school-level indicators of academic achievement, absenteeism, and disciplinary outcomes: A matched-pair, cluster-randomized, controlled trial. Journal of Research on Educational Effectiveness. 2009;3(1):26-55.

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Title and Abstract

1a. Title

Identification as a randomised trial in the title: not done, as only part of the study involves randomization

1b. Abstract

Structured summary of trial design, methods, results, and conclusions - done

Introduction

2a. Background

Scientific background and explanation of rationale - done

2b. Objectives

Specific objectives or hypotheses - done

2c. CONSORT-SPI 2018

If pre-specified, how the intervention was hypothesised to work.  done

Methods

3a. Trial Designs

Description of trial design (such as parallel, factorial) including allocation ratio done

3c. Changes to trial design

Important changes to methods after trial commencement (such as eligibility criteria), with reasons N/A

4a. Participants

Eligibility criteria for participants  done

4c. Study settings

Settings and locations of intervention delivery and where the data beingcollected

5a. Interventions 

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

5b. CONSORT-SPI 2018

Extent to which interventions were actually delivered by providers and taken up by participants as planned  N/A

6a. Outcomes 

Completely define pre-specified outcomes, including how and when they are being assessed

6b. Changes to outcomes 

Any changes to trial outcomes after the trial commenced, with reasons

7a. Sample size 

How sample size was determined

7b. Interim analyses and stopping guidelines

When applicable, an explanation of any interim analyses and stopping guidelines

8a. Randomisation: sequence generation

Method used to generate the random allocation sequence

8b. Randomisation: type

Type of randomisation; details of any restriction (such as blocking and block size)

9. Randomisation: allocation concealment mechanism 

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

10. Randomisation: implementation

Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

11a. Blinding 

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

11b. Similarity of interventions 

If relevant, description of the similarity of interventions

12a. Statistical methods 

Statistical methods used to compare group outcomes

12b. Extended CONSORT-SPI

How missing data were handled, with details of any imputation method

12c. Additional analyses 

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

Results

13a. Participant Flow 

Where possible, the number approached, screened, and eligible prior to random assignment, with reasons for non-enrolment

13b. Losses and exclusions 

For each group, losses and exclusions after randomisation, together with reasons

14a. Recruitment 

Dates defining the periods of recruitment and follow-up

14b. Reason for stopped trial 

Why the trial ended or was stopped

15. Baseline Data

Include socioeconomic variables where applicable

16. Numbers analysed 

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

17a. Outcomes and estimation 

For each outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

17b. CONSORT SPI

Indicate availability of trial data

17c. Binary outcomes

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

18.  Ancillary analyses 

Results of any other analyses performed, including subgroup analyses, adjusted analyses, and process evaluations, distinguishing pre-specified from exploratory

19. Harms

All important harms or unintended effects in each group (for specific guidance, see CONSORT for Harms) [14]

Discussion

20. Limitations

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

21. Generalisability 

Generalisability (external validity, applicability) of the trial findings

22. Interpretation

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

Other information

23. Registration

Registration number and name of trial registry

24. Protocol

Where the full trial protocol can be accessed, if available

25a. Funding 

Sources of funding and other support, role of funders

25b. Potential Interests

Declaration of any other potential interests

26a. Intervention involvement

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

26b. Stakeholder involvement

Other stakeholder involvement in trial design, conduct, or analyses

26c. Incentives

Incentives offered as part of the trial

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