EducationNCT07233967

Parent Resource About Pediatric Clinical Trials

A study testing Pediatric Clinical Trials (PCT) Pocket Guide in people with Education, run by Innovation Research & Training at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Education
What is being tested?: Pediatric Clinical Trials (PCT) Pocket Guide
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 167 participants
Where: 1 siteUnited States
Study dates: 19 Nov 2025to 2 Jan 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

having allowed their child to participate in a clinical trial

Trial locations and contacts

1 site in 1 country.

United States1 site

innovation Research & Training
Durham, North Carolina, 27713

Other trials in United States

About this study

Official title: Parent Toolkit to Educate Parents About Pediatric Clinical Research

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.

Read the 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.

Conditions: Education
Being tested: Pediatric Clinical Trials (PCT) Pocket Guide, Active Control Resource
Keywords: Pediatric clinical trials, Parents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pediatric Clinical Trials (PCT) Pocket GuideBehavioural
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 ResourceBehavioural
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.

Study groups in NCT07233967
Study group	Role	What they receive
Pediatric Clinical Trials (PCT) Pocket Guide	Experimental	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. Receives: Behavioral: Pediatric Clinical Trials (PCT) Pocket Guide
Active Control Resource	Active comparator	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. Receives: Behavioral: Active Control Resource

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 3
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.
Measured: Baseline and Week 3
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.
Measured: Baseline and Week 3
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.
Measured: Baseline and Week 3
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.
Measured: Baseline and Week 3
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.
Measured: Baseline and Week 3
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.
Measured: Baseline and Week 3
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.
Measured: Baseline and Week 3
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.
Measured: Baseline and Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 20252 Jan 2026

First posted18 Nov 2025
Study start19 Nov 2025
Primary completion2 Jan 2026
Study completion2 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EducationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07233967
Sponsor's protocol ID: Parentresource-FEA-25-002
Status last verified: Apr 2026
First submitted: 14 Nov 2025
Last updated: 2 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Parent Toolkit to Educate Parents About Pediatric Clinical Research
ClinicalTrials.gov ID: NCT07233967
Acronym / sponsor ID: Parentresource-FEA-25-002
Conditions: Education
Keywords: Pediatric clinical trials, Parents
Study type: Interventional
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: Innovation Research & TrainingUniversity, hospital or other
Study start: 19 Nov 2025 (actual)
Primary completion: 2 Jan 2026 (actual)
Study completion: 2 Jan 2026 (actual)
First posted: 18 Nov 2025 (actual)
Results: Posted 22 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Pediatric Clinical Trials (PCT) Pocket Guide	Experimental	Behavioral: Pediatric Clinical Trials (PCT) Pocket GuideParticipants 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.
Active Control Resource	Active comparator	Behavioral: Active Control ResourceParents will have access to content from a former NIH-supported website (Children and Clinical Studies) that includes articles and videos about pediatric clinical trials.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

having allowed their child to participate in a clinical trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pediatric Clinical Trials (PCT) Pocket GuideParents 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.	Behavioural	Pediatric Clinical Trials (PCT) Pocket Guide
Active Control ResourceParents will have access to content from a former NIH-supported website (Children and Clinical Studies) that includes articles and videos about pediatric clinical trials.	Behavioural	Active Control Resource

Primary outcome

Change From Baseline in Knowledge About Clinical Trials at Week 3
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 22 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pediatric Clinical Trials (PCT) Pocket Guide	84	60
Active Control Resource	83	63

Primary outcome: Change From Baseline in Knowledge About Clinical Trials at Week 3

Time frame: Baseline and Week 3. Least squares mean (Standard Error). Unit: units on a scale

Measure	Pediatric Clinical Trials (PCT) Pocket Guide n = 58	Active Control Resource n = 63
Value	17.48 (.25)	17.35 (.24)

Pediatric Clinical Trials (PCT) Pocket Guide vs Active Control Resource: p = .72, Regression, Linear

Primary outcome: Change From Baseline in Attitudes About Clinical Trials at Week 3

Time frame: Baseline and Week 3. Least squares mean (Standard Error). Unit: units on a scale

Measure	Pediatric Clinical Trials (PCT) Pocket Guide n = 58	Active Control Resource n = 63
Value	3.76 (.06)	3.79 (.06)

Pediatric Clinical Trials (PCT) Pocket Guide vs Active Control Resource: p = .73, Regression, Linear

Primary outcome: Change From Baseline in Beliefs About Clinical Trials at Week 3

Time frame: Baseline and Week 3. Least squares mean (Standard Error). Unit: units on a scale

Measure	Pediatric Clinical Trials (PCT) Pocket Guide n = 58	Active Control Resource n = 63
Value	3.73 (.05)	4.18 (.05)

Pediatric Clinical Trials (PCT) Pocket Guide vs Active Control Resource: p <.001, Regression, Linear

Primary outcome: Change From Baseline in Likelihood of Participation at Week 3

Time frame: Baseline and Week 3. Least squares mean (Standard Error). Unit: units on a scale

Measure	Pediatric Clinical Trials (PCT) Pocket Guide n = 58	Active Control Resource n = 63
Value	3.31 (.11)	3.28 (.10)

Pediatric Clinical Trials (PCT) Pocket Guide vs Active Control Resource: p = .85, Regression, Linear

Adverse events

Time frame: 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pediatric Clinical Trials (PCT) Pocket Guide	0 of 84 (0%)	0 of 84 (0%)	0
Active Control Resource	0 of 83 (0%)	0 of 83 (0%)	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alison Parker, PhD principal investigator

Innovation Research & Training

Tracy Scull, PhD principal investigator

Innovation Research & Training

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pediatric Clinical Trials (PCT) Pocket Guide in people with Education, run by Innovation Research & Training at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Knowledge About Clinical Trials at Week 3 (time frame: Baseline and Week 3). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07233967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.