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Parents' and children's experiences of participating in a randomized controlled clinical trial: AIDIT-QS

Peter Sand1, Emelie Kinberg2, Frida Sundberg3,4

  • 1Department of Psychology, University of Gothenburg, Gothenburg, Sweden.

International Journal of Qualitative Studies on Health and Well-Being
|October 3, 2024
PubMed

Insights

Parents and children found participating in a type 1 diabetes clinical trial rewarding, despite some burden. They would recommend research participation to others, highlighting the need for clear study information.

Area of Science:

  • Pediatric Endocrinology
  • Clinical Trial Methodology
  • Patient-Reported Outcomes

Background:

  • Family burden associated with pediatric complex randomized controlled trials (RCTs) is under-researched.
  • Limited studies explore the family's perspective on participating in research for severe childhood illnesses.
  • Type 1 diabetes diagnosis presents unique challenges for families entering clinical research.

Purpose of the Study:

  • To explore parents' and children's experiences participating in a type 1 diabetes clinical trial.
  • To understand motivations, decision-making processes, and overall experiences of research participation.
  • To identify factors influencing family engagement in pediatric clinical research.

Main Methods:

  • Qualitative study involving interviews with 16 parents and 9 children shortly after a type 1 diabetes diagnosis.
  • Independent researcher conducted semi-structured interviews focusing on inducement, decision-making, and experiences.
  • Exploration of parental (mothers and fathers) and child perspectives on trial participation.

Main Results:

  • Parents were motivated by a desire to improve diabetes treatment for all children and their own child.
  • Older children participated more in decision-making; clear communication is crucial post-diagnosis.
  • While the intervention group experienced some burden, participants in both groups recommended future research involvement.

Conclusions:

  • Family participation in pediatric type 1 diabetes trials is viewed positively, despite challenges.
  • Effective communication strategies are essential for informed consent and decision-making in clinical research.
  • Positive experiences and willingness to recommend underscore the value of family engagement in pediatric research.

Keywords:
Clinical trialRCTattitudeschildrenexpectationparentsparticipationqualitative studytype 1 diabetes mellitus

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