Trial Outcomes & Findings for Parent Resource About Pediatric Clinical Trials (NCT NCT07233967)

NCT ID: NCT07233967

Last Updated: 2026-05-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

167 participants

Primary outcome timeframe

Baseline and Week 3

Results posted on

2026-05-22

Participant Flow

167 parents were randomized to condition (intervention or active control)

Participant milestones

Participant milestones
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active 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. Active 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.
Overall Study
STARTED
84
83
Overall Study
Completed pretest
62
66
Overall Study
COMPLETED
58
61
Overall Study
NOT COMPLETED
26
22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Parent Resource About Pediatric Clinical Trials

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
n=84 Participants
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active Control Resource
n=83 Participants
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. Active 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.
Total
n=167 Participants
Total of all reporting groups
Age, Continuous
41.55 years
STANDARD_DEVIATION 6.69 • n=2 Participants
42.16 years
STANDARD_DEVIATION 7.10 • n=4 Participants
41.85 years
STANDARD_DEVIATION 6.89 • n=6 Participants
Sex: Female, Male
Female
70 Participants
n=2 Participants
73 Participants
n=4 Participants
143 Participants
n=6 Participants
Sex: Female, Male
Male
14 Participants
n=2 Participants
10 Participants
n=4 Participants
24 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants
n=2 Participants
18 Participants
n=4 Participants
37 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
65 Participants
n=2 Participants
65 Participants
n=4 Participants
130 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=2 Participants
0 Participants
n=4 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=2 Participants
2 Participants
n=4 Participants
3 Participants
n=6 Participants
Race (NIH/OMB)
Asian
4 Participants
n=2 Participants
7 Participants
n=4 Participants
11 Participants
n=6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=2 Participants
0 Participants
n=4 Participants
1 Participants
n=6 Participants
Race (NIH/OMB)
Black or African American
18 Participants
n=2 Participants
14 Participants
n=4 Participants
32 Participants
n=6 Participants
Race (NIH/OMB)
White
46 Participants
n=2 Participants
48 Participants
n=4 Participants
94 Participants
n=6 Participants
Race (NIH/OMB)
More than one race
14 Participants
n=2 Participants
12 Participants
n=4 Participants
26 Participants
n=6 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=2 Participants
0 Participants
n=4 Participants
0 Participants
n=6 Participants
Region of Enrollment
United States
84 participants
n=2 Participants
83 participants
n=4 Participants
167 participants
n=6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
n=58 Participants
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active Control Resource
n=63 Participants
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. Active 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.
Change From Baseline in Knowledge About Clinical Trials at Week 3
17.48 units on a scale
Standard Error .25
17.35 units on a scale
Standard Error .24

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
n=58 Participants
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active Control Resource
n=63 Participants
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. Active 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.
Change From Baseline in Attitudes About Clinical Trials at Week 3
3.76 units on a scale
Standard Error .06
3.79 units on a scale
Standard Error .06

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
n=58 Participants
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active Control Resource
n=63 Participants
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. Active 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.
Change From Baseline in Beliefs About Clinical Trials at Week 3
3.73 units on a scale
Standard Error .05
4.18 units on a scale
Standard Error .05

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
n=58 Participants
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active Control Resource
n=63 Participants
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. Active 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.
Change From Baseline in Likelihood of Participation at Week 3
3.31 units on a scale
Standard Error .11
3.28 units on a scale
Standard Error .10

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
n=58 Participants
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active Control Resource
n=63 Participants
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. Active 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.
Change From Baseline in Likelihood of Fear Preventing Participation at Week 3
2.61 units on a scale
Standard Error .14
2.82 units on a scale
Standard Error .14

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
n=60 Participants
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active Control Resource
n=63 Participants
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. Active 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.
Change From Baseline in Familiarity With Clinical Trials at Week 3
2.43 units on a scale
Standard Error .12
2.73 units on a scale
Standard Error .11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
n=58 Participants
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active Control Resource
n=63 Participants
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. Active 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.
Change From Baseline in Willingness to Participate at Week 3
4.54 units on a scale
Standard Error .14
4.47 units on a scale
Standard Error .13

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
n=58 Participants
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active Control Resource
n=62 Participants
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. Active 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.
Change From Baseline in Decision Self-efficacy at Week 3
3.55 units on a scale
Standard Error .08
3.43 units on a scale
Standard Error .07

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Pediatric Clinical Trials (PCT) Pocket Guide
n=58 Participants
Participants will have access to an intervention between pretest and posttest assessments. The intervention, PCT Pocket Guide, is an online, interactive resource designed to educate parents about pediatric clinical trials and inform their decision-making about their and their child's participation in future pediatric clinical trials. Pediatric 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.
Active Control Resource
n=62 Participants
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. Active 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.
Change From Baseline in Research Trust/Mistrust at Week 3
General Trustworthiness 1
3.98 units on a scale
Standard Error .08
4.15 units on a scale
Standard Error .08
Change From Baseline in Research Trust/Mistrust at Week 3
General Trustworthiness 2
3.64 units on a scale
Standard Error .12
3.67 units on a scale
Standard Error .12
Change From Baseline in Research Trust/Mistrust at Week 3
Perception of Deception
2.36 units on a scale
Standard Error .10
2.46 units on a scale
Standard Error .10
Change From Baseline in Research Trust/Mistrust at Week 3
Perception of Discriminatory Treatment
2.60 units on a scale
Standard Error .10
2.72 units on a scale
Standard Error .10
Change From Baseline in Research Trust/Mistrust at Week 3
Perception of Exploitation
2.17 units on a scale
Standard Error .10
2.39 units on a scale
Standard Error .10

Adverse Events

Pediatric Clinical Trials (PCT) Pocket Guide

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active Control Resource

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alison Parker

innovation Research & Training

Phone: 919-493-7700

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place