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Keep Calm and Carry on: Parental Opinions on Improving Clinical Dietary Trials for Young Children
Analise Nicholl1, Therese A O'Sullivan2
1School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Dr, Joondalup WA 6027, Australia. a.nicholl@ecu.edu.au.
Insights
Parental feedback on pediatric clinical assessments reveals key concerns like needle phobia and study misunderstandings. Addressing these issues through child-centered approaches can improve recruitment for pediatric research and clinical trials.
Area of Science:
- Pediatric Health Research
- Clinical Trial Design
- Parental Engagement in Research
Background:
- Recruitment challenges are common in pediatric research.
- Understanding parental perspectives is crucial for successful trial design.
- Previous literature may not fully address current parental concerns.
Purpose of the Study:
- To explore parental opinions on pediatric clinical assessments.
- To identify parental concerns regarding study design and enrollment.
- To inform the design of a pediatric clinical dietary trial using focus groups and literature review.
Main Methods:
- Convenience sampling recruited 17 parents of children aged 2-6 years.
- Three focus groups discussed proposed assessments, study design, and enrollment.
- Qualitative thematic analysis of transcripts was conducted using NVivo 11.
Main Results:
- Four primary parental concerns were identified: needle fear, children's coping abilities, study comprehension, and enrollment decision factors.
- Solutions included improving phlebotomy experiences, using engaging methods for children, providing clear multi-platform information, and adopting child-centered approaches.
- Parental concerns related to time commitment, respectful treatment, challenging tests, and altruism were also noted.
Conclusions:
- Addressing parental concerns regarding fear, understanding, and logistics is vital for pediatric research.
- Child-centered methodologies and clear communication can enhance participant engagement and improve recruitment.
- Findings can guide the design of pediatric clinical trials, particularly dietary interventions.
Abstract:
Recruitment can be an issue for paediatric research. We aimed to investigate parental opinions of paediatric clinical assessments, and to combine findings with recent literature to inform the design of a clinical dietary trial. We used convenience sampling to recruit 17 parents of children aged 2⁻6 years from two community playgroups in Perth, Western Australia. Three focus groups considered proposed child assessments, study design, and potential study enrolment. Qualitative thematic analysis of focus group transcripts used NVivo 11 (QSR, Melbourne, VIC, Australia). Four main parental concerns emerged, presented here with solutions combining parent responses and relevant literature. (1) Parent and child needle fear: a good experience and a good phlebotomist help keep participants calm, and offering additional analysis (e.g., iron status) makes blood tests more worthwhile. (2) Concerns about children's age, stage, understanding and ability to cope: create a themed adventure to help explain concepts and make procedures fun. (3) Persistent misunderstandings involving study purpose, design, randomization and equipoise: provide clear information via multiple platforms, and check understanding before enrolment. (4) Parental decisions to enrol children focused on time commitment, respectful treatment of their child, confronting tests and altruism: child-centred methodologies can help address concerns and keep participants engaged throughout procedures. Addressing the concerns identified could improve participation in a range of paediatric health interventions.
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