Mejia, Anilena
Emsley, Richard
Fichera, Eleonora
Maalouf, Wadih
Segrott, Jeremy
Calam, Rachel
Funding for this research was provided by:
Medical Research Council (MR/P010849/1)
Article History
Received: 8 February 2018
Accepted: 17 May 2018
First Online: 15 June 2018
Change Date: 4 March 2024
Change Type: Correction
Change Details: Additional information was updated to state that “This trial was discontinued.”
Change Details: https://doi.org/10.1186/s13063-018-2698-0
Ethics approval and consent to participate
: The study was granted ethical approval from the National Ethics Committee at Hospital Punta Pacifica in Panama (reference no. 28) on 23 March 2017 and from the Research Ethics Committee #1 at The University of Manchester (reference no. 2017–0717-3787) on 16 May 2017.All study participants will be provided with a Participant Information Sheet (which will be read out loud in the case of illiterate parents/children) about participation in each aspect of the trial. There will be separate Participant Information Sheets for adolescents and parents. Consent will only be considered informed following provision of adequate participant information and where participants have been given the opportunity to address any queries or concerns they may have about their participation.Parents/carers will provide consent for their children and themselves to take part and children/adolescents will also be asked to consent to their participation in the research. If there is more than one primary caregiver in the household, consent will be sought from one. The research trial comprises a number of different activities which participants will be asked to take part in (including providing self-report data and potential involvement in interviews for the study’s process evaluation). It will be explained to participants that they can choose to give consent for involvement in certain aspects of the study but decline consent for others. For example, participants can decide to provide self-report data but not consent to be interviewed for the process evaluation. Participants will be able to withdraw from the trial at any time before data analysis. For the process evaluation, informed consent will be obtained for all interviews and focus groups conducted with family members and other research participants (policy makers, intervention trainers and facilitators). Participants will be asked to give written consent at the start of their interview/focus group.
: The authors declare that they have no competing interests.
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