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Randomized Controlled Trial
. 2017 Jun 8;18(1):265.
doi: 10.1186/s13063-017-1962-z.

Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials

Jacqueline Martin-Kerry  1 , Peter Bower  2 , Bridget Young  3 , Jonathan Graffy  4 , Rebecca Sheridan  1 , Ian Watt  5 , Paul Baines  6 , Catherine Stones  7 , Jennifer Preston  8 , Steven Higgins  9 , Carrol Gamble  10 , Peter Knapp  11
Affiliations
Randomized Controlled Trial

Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials

Jacqueline Martin-Kerry et al. Trials. .

Abstract

Background: Randomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. However, recruitment and subsequent retention of children and adolescents in healthcare trials is challenging. Participant information sheets are often lengthy and difficult to read and understand. Presenting key information using multimedia may help to overcome these limitations and better support young people and their parents in deciding whether to participate in a clinical trial.

Methods: The TRECA (TRials Engagement in Children and Adolescents) study has two phases. The first phase involves a qualitative study with children and adolescents and their parents to inform the development of multimedia information resources and iterative user testing to refine the resources. The second phase will embed the use of the multimedia information resources into six host trials in the United Kingdom. Patients and parents approached to participate in the host trials will be randomly allocated to either use the multimedia information resource in conjunction with standard participant information sheets, the multimedia information resource alone, or the standard participant information sheets alone. The primary outcome will be the effect of the multimedia information resources on recruitment into trials. Other outcomes measured include the effect of multimedia information resources on retention of participants into the host trials and the impact on family members' decision-making processes, when compared to standard participant information sheets alone.

Discussion: This study will inform whether multimedia information resources, when developed using participatory design principles, are able to increase recruitment and retention of children and adolescents into trials. There is also the potential for patients to make better informed decisions through the use of multimedia information resources. The multimedia information resources also have the potential to assist with providing information on other healthcare decisions outside of clinical trials.

Trial registration: ISRCTN registry: ISRCTN73136092 (doi: 10.1186/ISRCTN73136092 ). Registered on 24 August 2016.

Keywords: Adolescent; Child; Consent; Decision-making; Information; Intervention; Multimedia; Parent; Recruitment; Retention; Trial participation.

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Figures

Fig. 1
Fig. 1
Possible pathway of effectiveness of multimedia information (MMI) resources
Fig. 2
Fig. 2
TRECA study design. MMI multimedia information
Fig. 3
Fig. 3
Development of the multimedia information (MMI) resources
Fig. 4
Fig. 4
Phase two study design. MMI multimedia information; CRN Clinical Research Network
See this image and copyright information in PMC

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