Hostname: page-component-cb9f654ff-rkzlw Total loading time: 0 Render date: 2025-07-31T13:19:02.421Z Has data issue: false hasContentIssue false
  • English
  • Français

Parental and adolescent perceptions of clinical trial participation: the FUEL randomised controlled trial and open-label extension study

Published online by Cambridge University Press:  21 May 2025

Linda M. Lambert Open the ORCID record for Linda M. Lambert [Opens in a new window] ,
Felicia Trachtenberg ,
Russell Gongwer ,
Thomas Giorgio ,
Olukayode Garuba ,
Sandra Mihelic ,
Kathleen Rathge ,
Martha Rolland ,
Cynthia Smith  and
Mary Stumpf
...Show all authors
Linda M. Lambert*
Affiliation:
Division of Pediatric Cardiothoracic Surgery, University of Utah, Salt Lake City, UT, USA
Felicia Trachtenberg
Affiliation:
Carelon Inc., Watertown, MA, USA
Russell Gongwer
Affiliation:
Carelon Inc., Watertown, MA, USA
Thomas Giorgio
Affiliation:
Boston Children’s Hospital, Boston, MA, USA
Olukayode Garuba
Affiliation:
Division of Cardiology, Texas Children’s Hospital, Baylor College of Medicine, Houston, TX, USA
Sandra Mihelic
Affiliation:
Children’s National Medical Center, Washington, DC, USA
Kathleen Rathge
Affiliation:
Division of Cardiology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
Martha Rolland
Affiliation:
Division of Cardiology, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada
Cynthia Smith
Affiliation:
Division of Cardiology, C.S. Mott Children’s Hospital, Ann Arbor, MI, USA
Mary Stumpf
Affiliation:
Division of Pediatric Cardiology, Riley Hospital for Children at IU Health, Indianapolis, IN, USA
Stacy Woyciechowski
Affiliation:
The Children’s Hospital of Philadelphia, Perelman School of Medicine, Philadelphia, PA, USA
Frances Woodard
Affiliation:
Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC, USA
Jennifer S. Yauck
Affiliation:
Herma Heart Institute, Children’s Wisconsin, Milwaukee, WI, USA
Victoria L. Pemberton
Affiliation:
Division of Cardiovascular Sciences, NIH, National Heart, Lung and Blood Institute, Bethesda, MD, USA
*
Corresponding author: Linda Lambert; Email: Linda.lambert@hsc.utah.edu
Get access Rights & Permissions [Opens in a new window]

Abstract

Introduction:

Adolescent and parental perceptions of the Fontan Udenafil Exercise Longitudinal Assessment Randomised Controlled Trial (FUEL) and its open-label extension were examined, to identify factors affecting future research participation.

Methods:

A validated survey was administered at two time points to adolescents (12–19 years) and their parents to assess likes/dislikes of study participation, research team, study burden and benefits. A 5-point Likert scale (strongly disagree [−2] to strongly agree [ + 2]) was used, and scores were averaged. Regression models explored potential predictors. Open-ended questions queried the most/least appealing aspects of participation and considerations for future research.

Results:

Among 250 FUEL participants at 14 centres, 179 adolescent and 183 parent surveys were completed at T1 (6 months after randomisation). Perceptions of research participation were generally positive: 1.35 ± 0.45 for adolescents; 1.56 ± 0.38 (p < 0.001) for parents. There were no significant differences between females vs. males. Themes from open-ended responses included liking to help others and themselves, liking the study team, and disliking study burden. Adolescents liked the compensation and disliked study-related testing. At T2 (end of open-label extension study), 121 adolescents and 114 parents responded. Perception scores remained high at 1.39 ± 0.51 for adolescents and 1.58 ± 0.37 for parents (p = 0.001). There were no significant gender differences in perceptions between adolescents, but mothers had slightly better perceptions than fathers (p = 0.004).

Conclusions:

Perceptions of research were positive and slightly better for parents. Study teams and compensation were key contributors to positive perceptions. Study burden and testing were viewed less favourably. Future studies should consider families’ preferences and potential barriers to participation.

Keywords

Congenital heart diseaseperceptions in researchparticipantadolescent

Information

Type
Original Article
Information
Cardiology in the Young , Volume 35 , Issue 6 , June 2025 , pp. 1109 - 1115
Check for updates
Copyright
© The Author(s), 2025. Published by Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Article purchase

Temporarily unavailable

References

Marceau, LD, Welch, LC, Pemberton, VL, Pearson, GD. Educating parents about pediatric research: children and clinical studies website qualitative evaluation. Qual Health Res 2016; 26 (8): 1114–1122. DOI: 10.1177/1049732315616620.CrossRefGoogle ScholarPubMed
Poll, Harris Interactive. Only a quarter (25%) of US adults would consider allowing a child of theirs to participate in a clinical research study. Health Care News 2004; 4: 1–8.Google Scholar
Caldwell, PH, Butow, PN, Craig, J. Parents’ attitudes to children’s participation in randomized controlled trials. J Pediatr 2003; 142 (5): 554–559.CrossRefGoogle ScholarPubMed
Hoehn, KS, Wernovsky, G, Rychik, J, et al. What factors are important to parents making decisions about neonatal research. Archives of Disease in Childhood: Fetal Neonatal Edition 2005; 90 (3): F267–9.CrossRefGoogle ScholarPubMed
Tait, AR, Voepel-Lewis, T, Malviya, S. Factors that influence parents’ assessments of the risks and benefits in research involving their children. Pediatrics 2004; 113 ( 4): 727–732.CrossRefGoogle ScholarPubMed
Singhal, N, Oberle, K, Burgess, E, Huber-Okrainec, J. Parents’ perceptions of research with newborns. J Perinatol 2002; 22 ( 1): 57–63.CrossRefGoogle ScholarPubMed
Zupancic, JA, Gillie, P, Streiner, DL, Watts, JL, Schmidt, B. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics 1997; 99 ( 1): e6–e6.CrossRefGoogle ScholarPubMed
Oster, ME, Lee, KA, Honein, MA, Riehle-Colarusso, T, Shin, M, Correa, A. Temporal trends in survival among infants with critical congenital heart defects. Pediatrics 2013; 131 (5): e1502–e1508. DOI: 10.1542/peds.2012-3435 Epub 2013 Apr 22.CrossRefGoogle ScholarPubMed
Stallings, EB, Isenburg, JL, Aggarwal, D, et al. National birth defects prevention network. Prevalence of critical congenital heart defects and selected co-occurring congenital anomalies, 2014-2018: a U.S. population-based study. Birth Defects Res 2022; 114 (2): 45–56. DOI: 10.1002/bdr2.1980.CrossRefGoogle Scholar
Luchtenberg, ML, Maeckelberghe, ELM, Locock, L, Verhagen, AAE. Understanding the child-doctor relationship in research participation: a qualitative study. BMC Pediatr 2020; 20 (1): 353. DOI: 10.1186/s12887-020-02243-1.CrossRefGoogle ScholarPubMed
Crane, S, Broome, ME. Understanding ethical issues of research participation from the perspective of participating children and adolescents: a systematic review. Worldviews Evid Based Nurs 2017; 14 (3): 200–209. DOI: 10.1111/wvn.12209 Epub 2017 Feb 16. PMID: 28207982; PMCID: PMC5724520.CrossRefGoogle ScholarPubMed
Hawke, LD, Relihan, J, Miller, J, et al. Engaging youth in research planning, design and execution: practical recommendations for researchers. Health Expect 2018; 21 (6): 944–949. DOI: 10.1111/hex.12795 Epub 2018 Jun 1.CrossRefGoogle ScholarPubMed
Sanz, JH, Anixt, J, Bear, L, et al. Characterisation of neurodevelopmental and psychological outcomes in CHD: a research agenda and recommendations from the cardiac neurodevelopmental outcome collaborative. Cardiol Young 2021; 31 (6): 876–887. DOI: 10.1017/S1047951121002146 Epub 2021 Jun 4.CrossRefGoogle ScholarPubMed
Orellana, M, Valdez-Soto, M, Brockman, TA, et al. Creating a pediatric advisory board for engaging youth in pediatric health research: a case study. J Clin Transl Sci 2021; 5 (1): e113. DOI: 10.1017/cts.2021.399.CrossRefGoogle ScholarPubMed
Supplementary material: File

Lambert et al. supplementary material 1

Lambert et al. supplementary material
Download Lambert et al. supplementary material 1(File)
File 70.5 KB
Supplementary material: File

Lambert et al. supplementary material 2

Lambert et al. supplementary material
Download Lambert et al. supplementary material 2(File)
File 50.8 KB
Supplementary material: File

Lambert et al. supplementary material 3

Lambert et al. supplementary material
Download Lambert et al. supplementary material 3(File)
File 50.9 KB