PURPOSE: To examine similarities and differences in the process that parents and adolescents use to make decisions concerning participation in an asthma clinical trial. We hypothesized that a single conceptual model, tested through structural equations modeling, could explain adolescent assent and parent consent for adolescent research participation. METHODS: One hundred nine adolescents enrolled with at least one parent and received an asthma evaluation from a pediatric asthma specialist and then evaluated a hypothetical asthma research protocol. Family members independently evaluated the protocol and made research participation decisions. RESULTS: Perceived risk, benefit, and compensation were direct predictors of participation decisions for parents and adolescents. Adolescents perceived direct study benefit from the relationship with the physician, however parents did not. Parent decisions were most strongly associated with perceived risk, and parents associated discomfort with risk more strongly than did adolescents. Protocol procedures contributed to perceptions of benefit and discomfort for parents and adolescents. CONCLUSIONS: Parent and adolescent research participation decisions are influenced by protocol variables in similar ways, although there are differences that account for disagreements within families. Findings may help investigators develop protocols that appeal to parents and adolescents and highlight issues of particular importance to address during the process of informed consent.
PURPOSE: To examine similarities and differences in the process that parents and adolescents use to make decisions concerning participation in an asthma clinical trial. We hypothesized that a single conceptual model, tested through structural equations modeling, could explain adolescent assent and parent consent for adolescent research participation. METHODS: One hundred nine adolescents enrolled with at least one parent and received an asthma evaluation from a pediatric asthma specialist and then evaluated a hypothetical asthma research protocol. Family members independently evaluated the protocol and made research participation decisions. RESULTS: Perceived risk, benefit, and compensation were direct predictors of participation decisions for parents and adolescents. Adolescents perceived direct study benefit from the relationship with the physician, however parents did not. Parent decisions were most strongly associated with perceived risk, and parents associated discomfort with risk more strongly than did adolescents. Protocol procedures contributed to perceptions of benefit and discomfort for parents and adolescents. CONCLUSIONS: Parent and adolescent research participation decisions are influenced by protocol variables in similar ways, although there are differences that account for disagreements within families. Findings may help investigators develop protocols that appeal to parents and adolescents and highlight issues of particular importance to address during the process of informed consent.
Authors: David G Scherer; Janet L Brody; Robert D Annett; Jeanne Hetter; Laura Weiss Roberts; Keely M W Cofrin Journal: J Pediatr Date: 2005-04 Impact factor: 4.406
Authors: Mary Beth Happ; Leslie A Hoffman; Linda W Higgins; Dana Divirgilio; Dana DiVirgilio; David M Orenstein Journal: Nurs Res Date: 2013 Sep-Oct Impact factor: 2.381
Authors: Irma M Hein; Pieter W Troost; Martine C de Vries; Catherijne A J Knibbe; Johannes B van Goudoever; Ramón J L Lindauer Journal: Pediatr Res Date: 2015-04-09 Impact factor: 3.756
Authors: Jenny K R Francis; Lily F Hoffman; Mei-Chen Hu; Ariel M de Roche; Marina Catallozzi; Carmen Radecki Breitkopf; Susan L Rosenthal Journal: J Pediatr Adolesc Gynecol Date: 2015-09-25 Impact factor: 1.814
Authors: Susan L Rosenthal; Ariel M de Roche; Marina Catallozzi; Carmen Radecki Breitkopf; Lisa S Ipp; Jane Chang; Jenny K R Francis; Mei-Chen Hu Journal: J Pediatr Adolesc Gynecol Date: 2016-01-25 Impact factor: 1.814
Authors: Sara E Watson; Paul Smith; Jessica Snowden; Vida Vaughn; Lesley Cottrell; Christi A Madden; Alberta S Kong; Russell McCulloh; Crystal Stack Lim; Megan Bledsoe; Karen Kowal; Mary McNally; Lisa Knight; Kelly Cowan; Elizabeth Yakes Jimenez Journal: Clin Transl Sci Date: 2022-01-21 Impact factor: 4.438
Authors: Rachel G Greenberg; Breck Gamel; Diane Bloom; John Bradley; Hasan S Jafri; Denise Hinton; Sumathi Nambiar; Chris Wheeler; Rosemary Tiernan; P Brian Smith; Jamie Roberts; Daniel K Benjamin Journal: Contemp Clin Trials Commun Date: 2017-11-23