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Text messages (SMS) alert participants to the forthcoming interview and inform them that an interviewer will be contacting them.
Interviews, conducted by a trained qualitative interviewer, will be approximately 30-min in length and typically conducted by phone.
For the telephone interview six months after discharge the interviewer will be unaware of the intervention group that the patient belongs to.
For the assessment of the outcomes during a telephone interview two weeks after discharge the interviewer will be aware of the intervention group a patient belongs to because specific additional questions for each intervention group will be asked to evaluate the interventions.
In case of evidence for blinding break down, the interviewer will be changed to the second outcome interview.
The interviewer will be blinded to randomization at the baseline interview.
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At the 5, 12 and 26 week follow-up interviews, the interviewers will be unaware of the participants' treatment assignments.
To ensure a high level of interview standardisation between the different centres, interviewers will be provided with protocols and guidelines.
Trained interviewers will be responsible for conducting face-to-face interviews, using structured questionnaires, with mothers and fathers together and separately, although in approximate times.
To enable subsequent assessment of the effectiveness of the blinding, interviewers will be asked at the completion of the interview to indicate the treatment condition to which they believe the participant was allocated.
The follow-up interviewers will be introduced to the patients at the baseline interview, to assure blinded follow-up assessments.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com