Child and parent reactions to participation in clinical research

doi:10.1016/j.genhosppsych.2004.08.007

General Hospital Psychiatry

Volume 27, Issue 1, January–February 2005, Pages 29-35

https://doi.org/10.1016/j.genhosppsych.2004.08.007 Get rights and content

Abstract

Background

Psychological and psychiatric research studies in medical settings often enroll children who are ill, injured, coping with pain or undergoing stressful medical procedures. Yet empirical evidence to date regarding the effects of research on these participants is scarce. This study assessed reactions of injured children and their parents to research participation and examined associations with demographic, injury and acute stress variables.

Methods

Administered standard research reactions questionnaires to 203 injured children (5–17) and 200 parents participating in a study of acute posttraumatic stress.

Results

Fifty-two percent of children and 74% of parents were glad they had participated; 77% of children and 90% of parents felt good about helping others. Self-reported distress from study participation was uncommon (5% of children and parents). Child age was associated with more positive appraisals of the research process and with greater trust in and information about elements of informed consent.

Conclusions

Participation in a research interview following traumatic injury had little risk of generating distress for children or parents. The most commonly reported positive aspect of research participation was feeling good about helping others. This study supports the feasibility of incorporating standardized assessment of participant reactions in clinical research protocols.

Section snippets

Introduction and background

Investigators in all fields of study must balance potential risks and benefits to research participants, but psychiatrists, psychologists and pediatric physicians conducting clinical research with children in medical settings often have a particularly compelling need to do so. In order to understand the responses of individuals to challenging health problems and to develop empirically sound interventions, these researchers frequently recruit ill or injured children as participants. Yet little

Participants

In a study protocol approved by the hospital IRB, children admitted to a large Mid-Atlantic urban pediatric hospital for a traffic-related injury (pedestrians, bicyclists and motor vehicle passengers) were enrolled in an ongoing prospective study of posttraumatic stress symptoms. Between June 2000 and October 2001, 345 eligible children were identified. The research team contacted parents or guardians of 307 (89%) of the eligible children within 1 month post-injury to invite participation in

Description of participant responses

The frequency of participant responses for each item on the RRPQ-C and the RRPQ-P is presented in Table 1 and Table 2, respectively. The majority of children and parents endorsed positive appraisals of research participation: 52% of children were glad they were in the study (endorsing “yes”), 58% felt good about themselves as a result of participating and 77% felt good about helping others; these items were endorsed by 74%, 55% and 90% of parents, respectively (endorsing “agree” or “strongly

Discussion

The current study found little risk of research-generated distress for children and parents participating in a research interview and answering questionnaires within a month of being hospitalized for a traumatic injury. Few children or parents reported regret, sadness or upset from participation. Our results are consistent with those of the only other published study to date that assessed child and parent reactions to participation in an interview-based study [16]. Taken together, these

Acknowledgment

This work was funded in part by a grant from the Maternal and Child Health Bureau (#R40 MC 00138 03).

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Some other studies in trauma-focused research investigated children's experiences by using the Reactions to Research Participation Questionnaire for Children (RRPQ-C) (Kassam-Adams and Newman, 2002), which includes three questions on children's discomforts: feeling bored during the study, feeling upset or sad during the study, and feeling sorry for having taken part in the study. Studies that used this questionnaire for investigating the discomforts of trauma-focused research showed that the majority of the children was not bored, upset/sad or felt sorry about participating in these research studies (Chu et al., 2008; Kassam-Adams and Newman, 2005; Seedat et al., 2004). There is also some literature on the (expected) discomforts that children mention in hypothetical research situations, e.g. (Bernhardt et al., 2003; Brody et al., 2003).
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Child and parent reactions to participation in clinical research

Abstract

Background

Methods

Results

Conclusions

Section snippets

Introduction and background

Participants

Description of participant responses

Discussion

Acknowledgment

Gen. Hosp. Psychiatry

Gen. Hosp. Psychiatry

Compr. Psychiatry

J. Pediatr.

Gen. Hosp. Psychiatry

Pain

Pain

Final regulations amending basic HHS policy for the protection of human research subjects

Fed. Regist.

Responsible research: a systems approach to protecting research participants

The Belmont Report: ethical principles and guidelines for the protection of human subjects of research

Human subjects review, personal values, and the regulation of social science

Am. Psychol.

Ethical decision making among trauma researchers

Empirical studies of ethical issues in research: a research agenda

Am. Psychol.

Distress in response to and perceived usefulness of trauma research interviews

J. Trauma Dissociation

The experience of participating in bereavement research: stressful or therapeutic?

Death Stud.