Parent Resource About Pediatric Clinical Trials

NCT ID: NCT07233967

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-19

Study Completion Date

2026-04-30

Brief Summary

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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

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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

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Education

Keywords

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Pediatric clinical trials Parents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Pediatric Clinical Trials (PCT) Pocket Guide

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Active Control Resource

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 already participated or allowed their child to participate in a clinical trial;
* responding with very high research trustworthiness (score of 5 on 5-point Likert scale for two items on Research Trust/Mistrust measure) on the eligibility screener.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovation Research & Training

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison Parker, PhD

Role: PRINCIPAL_INVESTIGATOR

Innovation Research & Training

Tracy Scull, PhD

Role: PRINCIPAL_INVESTIGATOR

Innovation Research & Training

Locations

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innovation Research & Training

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alison Parker, PhD

Role: CONTACT

Phone: 919-493-7700

Email: [email protected]

Tracy Scull, PhD

Role: CONTACT

Phone: 919-493-7700

Email: [email protected]

Facility Contacts

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Alison Parker, PhD

Role: primary

Other Identifiers

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Parentresource-FEA-25-002

Identifier Type: -

Identifier Source: org_study_id