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BRIEF Educational Module for Improving Study Enrollment (BRIEF Trial)

N/A
Waitlist Available
Led By Stephanie A Kraft, JD
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Neonates (born between 24-0 and 31-6 weeks of gestation) at the University of Washington Medical Center (UWMC) eligible for inclusion in the Darbe plus IV Iron (DIVI) study; OR Parents or legally authorized representatives (LARs) of neonates approached for participation in the DIVI study; OR Members of the DIVI research team involved in recruitment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through partner study completion, up to 1 year
Awards & highlights

BRIEF Trial Summary

This trial is testing a new way to recruit participants for a neonatal study in order to improve the experience for parents and decrease disparities.

Who is the study for?
This trial is for newborns born between 24-0 and 31-6 weeks of gestation at the University of Washington Medical Center, their parents or legal representatives, and members of the research team involved in recruitment. It aims to improve parent experience during enrollment in neonatal trials and reduce disparities.Check my eligibility
What is being tested?
The study tests a new approach called BRIEF Intervention within an ongoing neonatal clinical trial (DIVI). The goal is to see if this method makes it easier for families to participate in studies and helps more diverse groups join by making changes halfway through the existing DIVI study.See study design
What are the potential side effects?
Since BRIEF is an educational module aimed at improving communication, there are no direct medical side effects expected from participating. However, any potential indirect impacts on family stress levels or decision-making processes will be monitored.

BRIEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

BRIEF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through partner study completion, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through partner study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Patient Experiences of Respect During Research Recruitment
Patient Trust in Research
Study Enrollment Rates
Secondary outcome measures
Enrollment
Perceived respect
Retention
+1 more

BRIEF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BRIEF ArmExperimental Treatment1 Intervention
Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment after implementation of the BRIEF intervention.
Group II: Control ArmActive Control1 Intervention
Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment before implementation of the BRIEF intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BRIEF Educational Module
2022
N/A
~140

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
302 Previous Clinical Trials
5,216,586 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,698 Previous Clinical Trials
7,492,361 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,592 Total Patients Enrolled

Media Library

BRIEF Arm Clinical Trial Eligibility Overview. Trial Name: NCT04152603 — N/A
Respect Research Study Groups: Control Arm, BRIEF Arm
Respect Clinical Trial 2023: BRIEF Arm Highlights & Side Effects. Trial Name: NCT04152603 — N/A
BRIEF Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04152603 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the number of participants in this study?

"That is accurate, the clinicaltrials.gov website does state that this study is open for recruitment. The listing for this trial was first created on October 10th, 2020 and was last updated on October 25th, 2020. They are looking for a total of 300 participants at a single site."

Answered by AI

Are interested parties still able to join this research project?

"That is accurate. The information available on clinicaltrials.gov indicates that this study is still looking for patients. The posting date was October 10th, 2022 and the most recent update was on October 25th, 2022. They are hoping to enroll 300 individuals at a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Better Research Interactions for Every Family
Stephanie Kraft 2022. "Better Research Interactions for Every Family". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04152603.
~55 spots leftby Apr 2025
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