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Child and parent reactions to participation in clinical research

Nancy Kassam-Adams1, Elana Newman

  • 1TraumaLink and Center for Pediatric Trauma Stress, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA. nlkaphd@mail.med.upenn.edu

General Hospital Psychiatry
|February 8, 2005
PubMed

Insights

Research participation is safe for injured children and their parents, with most reporting positive experiences and no distress. Feeling helpful was the most valued aspect of joining medical studies.

Area of Science:

  • Pediatric Psychology
  • Clinical Research Ethics

Background:

  • Medical research often involves vulnerable pediatric populations experiencing illness, injury, or distress.
  • Limited empirical data exists on the impact of research participation on these children.
  • This study addresses the need for evidence on children's and parents' reactions to research.

Purpose of the Study:

  • To assess injured children's and their parents' reactions to participating in a research study.
  • To examine how demographic, injury, and acute stress variables correlate with these reactions.

Main Methods:

  • Surveyed 203 injured children (aged 5-17) and 200 parents.
  • Utilized standard questionnaires to measure research reactions.
  • Participants were involved in a study on acute posttraumatic stress.

Main Results:

  • A majority of children (52%) and parents (74%) were glad to participate.
  • Most participants felt positive about contributing to research (77% of children, 90% of parents).
  • Distress from participation was infrequent (5% for both children and parents); older children reported more positive research experiences.

Conclusions:

  • Research interviews following traumatic injury pose minimal risk of distress for pediatric participants and their families.
  • The primary benefit reported by participants was the altruistic value of helping others.
  • Integrating participant reaction assessments into clinical research is feasible and recommended.
Abstract

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