소아 임상시험에 대한 상위 리소스

실험적: 소아 임상시험(PCT) 포켓 가이드

참가자들은 사전 평가와 사후 평가 사이에 중재 프로그램에 접근할 수 있습니다. 이 중재 프로그램인 PCT 포켓 가이드는 온라인 상호작용형 자료로, 부모들에게 소아 임상시험에 대해 교육하고 향후 소아 임상시험에 자신과 자녀가 참여할 것인지에 대한 의사결정을 돕도록 설계되었습니다.

행동: 소아 임상시험(PCT) 포켓 가이드

부모는 소아 임상 시험에 대한 정보를 제공하는 멀티미디어 교육 자료와 상호 작용하게 됩니다. 여기에는 참가자의 권리와 안전, 역할, 가족, 연구원 및 의료 제공자와의 의사 소통과 관련된 주제가 포함되며, 공유 의사 결정을 위한 전략을 제공합니다.

활성 비교기: 활성 대조군 자원

부모들은 이전 NIH 지원 웹사이트(아동과 임상 연구)의 콘텐츠에 접근할 수 있으며, 여기에는 소아 임상 시험에 관한 기사와 동영상이 포함됩니다.

행동: 활성 대조군 자원

부모님들은 이전 NIH 지원 웹사이트(Children and Clinical Studies)의 콘텐츠에 접근할 수 있으며, 여기에는 소아 임상시험에 관한 기사와 동영상이 포함되어 있습니다.

Change From Baseline in Knowledge About Clinical Trials at Week 3

Parents will respond to 8 questions that will assess their factual knowledge about pediatric clinical research (e.g., What does giving 'assent' mean?). Questions are in multiple choice format (some questions have multiple correct answers), and the total score could range from 0-19 correct. Higher scores indicate more knowledge about clinical research.

Change From Baseline in Attitudes About Clinical Trials at Week 3

Parents will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about children and teens participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate more positive attitudes toward clinical trials.

Change From Baseline in Beliefs About Clinical Trials at Week 3

Parents will be asked to respond to 5 questions about their beliefs about pediatric clinical trials (e.g., I believe that clinical trials are safe for children and teens.; 1=Strongly disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly agree). Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate more positive beliefs about clinical trials.

Change From Baseline in Likelihood of Participation at Week 3

Parents will be asked to respond to one question about the likelihood of allowing their child to participate in a clinical trial (i.e., If your child were asked to be in a clinical trial, how likely would you be to let them participate?; 1 = Not likely; 2 = Somewhat likely; 3 = Moderately likely; 4 = Very likely; 5 = Extremely likely). Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater likelihood of allowing child to participate in a clinical trial.

Change From Baseline in Likelihood of Fear Preventing Participation at Week 3

Parents will be asked to respond to one question about the likelihood of their fear preventing them from allowing their child to participate in a clinical trial (i.e., How likely is it that your fearful or anxious feelings could stop you from allowing your child to participate in a clinical trial in the future?; 1 = Not likely; 2 = Somewhat likely; 3 = Moderately likely; 4 = Very likely; 5 = Extremely likely). Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater likelihood of fear preventing participation in a clinical trial.

Change From Baseline in Familiarity With Clinical Trials at Week 3

Parents will be asked to respond to one question about their familiarity with clinical trials [How much do you know about pediatric clinical trials (research studies with children under 18; 1 = I don't know anything about them; 2 = I know a little about them; 3 = I know some things about them; 4 = I know a lot about them; 5 = I know all there is to know about them]. Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater familiarity with pediatric clinical trials.

Change From Baseline in Willingness to Participate at Week 3

Parents will review up to five research protocols related to a fictitious disease ('meditis') and respond to questions about their willingness to let their child participate in each research study (i.e., "If your child had meditis, would you agree to enroll them in this study?"; 1 = Definitely not to 7 = Definitely yes). Responses will be averaged across the five protocols and the minimum scale score is 1 and the maximum scale score is 7. Higher scores indicate greater willingness to allow their child to participate in the research studies.

Change From Baseline in Decision Self-efficacy at Week 3

Parents will be asked to respond to 11 questions about their confidence in obtaining information, asking questions, and making an informed decision about their child's participation in a clinical trial (e.g., Get the facts about the risk and side effects of each choice.; 0 = Not at all confident; 4 = Very confident). Responses will be averaged and the minimum scale score is 0 and the maximum scale score is 4. Higher scores indicate greater decision self-efficacy.

Change From Baseline in Research Trust/Mistrust at Week 3

Parents will be asked to respond to 10 questions regarding their trust/mistrust in research (My attitude towards medical research can best be described as positive.; 1 = Strongly disagree; 4 = Strongly agree). The measure has four factors: General Trustworthiness; Perception of Deception; Perception of Exploitation; and Perception of Discriminatory Treatment. Responses will be averaged across each factor and the minimum scale score is 1 and the maximum scale score is 4. Higher scores indicate greater general trustworthiness, greater perceptions of deception, greater perceptions of exploitation, and greater perceptions of discriminatory treatment.