5.-YEF-pilot-trial-protocol-template-updated-Jan-2022

Sep 1, 2026

YEF pilot trial protocol template for studies that include a control group, designed to document an RCT-aligned pilot with feasibility and acceptability focus. The template supports structured reporting informed by CONSORT 2010 extensions, and emphasizes clear version control to track changes to the evaluation plan. It provides section guidance for study rationale, background, intervention description, research questions, and success criteria, including implementation and process evaluation considerations, control/comparison setup, and attention to cultural and racial sensitivity across participant groups.

LanguageEnglish

CategoryLetters

FormatDOCX

Pages13

Reading Time5 min

AccessFree to download

Study rationale and background

Intervention

Research questions and/or objectives

Success criteria and/or targets

Pilot trial protocol template (includes a control group) Evaluating institution: [Organisation] Principal investigator(s): [Name(s)] This template should be used for all YEF pilot trials that involve a control group (with adaptations, as necessary). Most YEF pilot studies will involve delivering a small-scale version of the main study, particularly where an RCT design is proposed, because this is the best way to test the acceptability and feasibility of these designs. Please refer to YEF’s guidance on pilot studies. The protocol does not need to follow the template precisely, but evaluators should consider including the following items. The protocol has been developed with reference to the CONSORT 2010 statement: extension to randomised pilot and feasibility trials. The relevant CONSORT item is provided in brackets. The version history below will help to keep track of any changes to the evaluation plan. The version history below will help to keep track of any changes to the protocol. Any guidance notes (in italics) can be deleted on completion and replaced with the actual text which should not be in italics and instead in justified black Calibri font size 12 with 10pt spacing before and after and multiple 1.15 line spacing. Protocol version history Any changes to the design need to be discussed with the YEF Evaluation Manager (EM) and the developer team prior to any change(s) being finalised. Describe in the table above any agreed changes made to the evaluation design, research questions and approach, and the rational for these. Table of contents Please insert (with section links, if possible). Study rationale and background Provide an explanation of the theoretical and scientific background, policy and practice context and rationale for the intervention (including the targeted problem or issue) and evaluation (including any contradictory evidence). Please include references to the academic and policy literature as relevant (and a full reference list for any in-text citations) (CONSORT 2a). Provide a brief overview of the evaluation design (including implementation and process evaluation), explaining the rational for design (CONSORT 1b). If a previous YEF evaluation was conducted of the same intervention (i.e., a feasibility study), describe it briefly here and how it informed this project, including any changes to the intervention (e.g. content, delivery) and evaluation design (e.g. randomisation, outcomes, control condition). Intervention Please include a detailed description of the intervention being evaluated, including any training and the model of delivery (this could also be filled by the delivery team). Whilst much of this information will come from the delivery team, the evaluator needs to include sufficient information in the evaluation protocol to justify their evaluation design. Wherever possible, please include as much information from Step 1 of EIF’s 10 steps to evaluation success as possible, i.e. Outcomes, Why (theory/rationale/ business as usual), Who (recipients, universal/targeted), What (materials, procedures, providers, location, frequency, format, training and quality assurance), and How much (dosage) sufficient to enable replication (CONSORT 5). All studies should be carried out with due regard to racial and cultural sensitivity and for each project it will be important to explicitly assess the experience of different groups of children and young people who receive the project where possible.Where possible explain where further information about delivering the intervention can be accessed (CONSORT-SPI 5b) Explain how the intervention is hypothesised to work, including the logic model agreed with the developer during the set-up phase and a description of the causal pathway for each participant group, underlying mechanisms and assumptions at each step (see Step 2 of EIF’s ten steps to evaluation success) (CONSORT-SPI 2b). Describe any control or comparison conditions. Describe any incentives or restricti

FAQs

What type of YEF pilot trials should use this protocol template?

This template is for all YEF pilot trials that involve a control group. If the pilot does not involve a control group, a different pilot study plan template should be used.

How does the template support evaluation design and reporting quality?

The protocol is developed with reference to the CONSORT 2010 statement extensions to randomised pilot and feasibility trials, and it provides guidance items and placeholders to ensure key evaluation elements are included.

What must be done before finalizing changes to the protocol or evaluation design?

Any changes to the design need to be discussed with the YEF Evaluation Manager and the developer team before being finalized, and agreed changes should be described in the table referenced in the template.

Sep 1, 2026

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