None listed
Conditions
Brief summary
The ACORN Trial is investigating different approaches to seeking consent from families for researchers to access their child’s routinely collected health and education data. Participants are parents whose child(ren) participated in one of three neonatal randomised trials, and are now being approached for consent to in-person follow-up assessment when the child(ren) are 6 years old. We are investigating whether rates of consent are higher when we seek consent for data access before or after the in-person assessment and when we seek consent for accessing health and education data together or separately.
Interventions
Parents of children who participated in the primary trials and are contacted for consent to in person follow-up assessments when the child is 6-7 years of age will be randomised to being asked for consent to researchers accessing routinely collected data about their children using different approaches in a factorial design:
Factor 1: Concurrent vs delayed consent
- Concurrent consent: Consent to data linkage will be requested at the same time as consent to the in-person follow-up assessment.
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Parents of children who participated in the primary trials and are contacted for consent to in person follow-up assessments when the child is 6-7 years of age will be randomised to being asked for consent to researchers accessing routinely collected data about their children using different approaches in a factorial design: Factor 1: Concurrent vs delayed consent - Concurrent consent: Consent to data linkage will be requested at the same time as consent to the in-person follow-up assessment. - Delayed consent: Consent to data linkage will be requested after the in-person follow-up assessment, mailed along with the letter summarising the findings of the in-person assessment. This will be approximately one month after the in-person assessment. Factor 2: Separate vs combined consent - Separate consent: Consent to data linkage for health and education data will be requested separately, as two different questions on the consent form. - Combined consent: Consent to data linkage of health and education data will be requested together, as a single question on the consent form. All other details of the consent forms, and information provided to participants will be otherwise identical.
Sponsors
Liggins Institute, The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Parents of all surviving children who took part in the pre-hPOD, hPOD or ProViDe trials in New Zealand and who are able to be contacted to seek consent for the NIEOS study (Neonatal Nutritional Interventions Early School-age Outcomes Studies). The NIEOS study is a follow-up study of children who participated in pre-hPOD, hPOD or ProViDe trials and are being assessed at school age (6-7 years corrected for preterm birth) for neurocognitive function, health and wellbeing, and cardiometabolic function.
Exclusion criteria
Participants who have previously withdrawn or refused consent for contact for follow-up, whose child has died, or who are outside New Zealand at the time of follow-up.
Outcome results
None listed