Parent Resource About Pediatric Clinical Trials

Innovation Research & Training

Status: Enrolling

Conditions: Education

Treatments: Behavioral: Pediatric Clinical Trials (PCT) Pocket Guide; Behavioral: Active Control Resource

Study type: Interventional

Funder types: Other

Identifiers

NCT07233967

Parentresource-FEA-25-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Pediatric Clinical Trials (PCT) Pocket Guide

Experimental group

Description:

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.

Treatment:

Behavioral: Pediatric Clinical Trials (PCT) Pocket Guide

Active Control Resource

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active Control Resource