Education
Conditions
Keywords
Pediatric clinical trials, Parents
Brief summary
The overall aim of this project is to examine the feasibility of a web-based resource for parents to educate them about pediatric clinical research.
Detailed description
Parents (N = 150) of children aged 7-17 years will be recruited from across the United States to participate in a randomized controlled trial. Adult consent will be sought. Participants will be randomized into one of two study arms: intervention and active control. All participants will complete a web-based pretest questionnaire. Participants will then receive access to their randomly assigned resource. Approximately 2-3 weeks after completing the pretest questionnaire, all participants will complete a web-based post-test questionnaire.
Interventions
BEHAVIORALPediatric Clinical Trials (PCT) Pocket Guide
Parents will interact with a multimedia educational resource that will provide information about pediatric clinical trials, including topics related to participant rights and safety, roles, communication with family, researchers, and healthcare providers, and will provide strategies for shared decision-making.
BEHAVIORALActive Control Resource
Parents will have access to content from a former NIH-supported website (Children and Clinical Studies) that includes articles and videos about pediatric clinical trials.
Sponsors
Innovation Research & Training
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult participant is a parent or legal guardian of child between ages 7 and 17; * Participant's child attends school where recruitment flyers have been sent or report that they heard about the study from one of the study recruitment partners; * Parent has access to a computer or tablet or smart phone with internet connection (as the resource and questionnaires are web-based); and * Parent is fluent in English or Spanish.
Exclusion criteria
* having allowed their child to participate in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Knowledge About Clinical Trials at Week 3 | Baseline and 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 | Baseline and 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 | Baseline and 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 | Baseline and 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 | Baseline and 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 | Baseline and 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 | Baseline and 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 | Baseline and 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 | Baseline and 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlison Parker, PhD
Innovation Research & Training
PRINCIPAL_INVESTIGATORTracy Scull, PhD
Innovation Research & Training
Participant flow
Pre-assignment details
167 parents were randomized to condition (intervention or active control)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.16 years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 94 Participants |
| Region of Enrollment United States | 167 participants |
| Sex: Female, Male Female | 143 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 84 | 0 / 83 |
| serious Total, serious adverse events | 0 / 84 | 0 / 83 |
Outcome results
None listed