RespectBRIEFNCT04152603

Better Research Interactions for Every Family

A study testing BRIEF Educational Module in people with Respect and Trust, run by Seattle Children's Hospital 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

Who is it for?: Ages 0 years and olderHealthy volunteers can take part
Conditions the study is for: Respect, Trust, Study Enrollment
What is being tested?: BRIEF Educational Module
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 1 siteUnited States
Study dates: 10 Oct 2022to 31 Dec 2023
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 0 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington Medical Center
Seattle, Washington, 98195

Other trials in United States

About this study

This is a study of the feasibility of implementing a modified recruitment approach, the Better Research Interactions for Every Family (BRIEF) Intervention, within a neonatal clinical trial. This intervention has two distinct aims: 1) improve the experience for parents asked to enroll their infant in a neonatal clinical trial; and 2) decrease disparities in enrollment within a neonatal clinical trial. The investigators will apply the BRIEF within a single site neonatal RCT, the Darbe plus IV Iron (DIVI) study, using a pre/post approach. The intervention will be implemented approximately halfway through recruitment for the DIVI study. The objectives of this study are to assess feasibility, gain preliminary experience to drive further refinement, and provide effect estimates for a future RCT of the BRIEF intervention.

Read the detailed description

The BRIEF Intervention will test the hypothesis that an evidence-based, researcher-facing educational module will improve the enrollment process for eligible families and increase diversity of populations enrolled in research. These in turn will improve the generalizability of neonatal clinical trials. The BRIEF Intervention is an educational module based on data about how research teams can approach families about research in a more equitable and respectful manner. The intervention will be implemented approximately halfway through DIVI study recruitment. The BRIEF team will measure outcomes, comparing before versus after the BRIEF Intervention is implemented, across three groups of participants:

Neonates eligible for participation in the DIVI study, identified through the records of the DIVI team. Research activities for this group are limited to extraction of targeted demographic and clinical data from the medical record by the BRIEF study team.
Parents/legally authorized representatives (LARs) of infants approached for the DIVI study who will be invited to take a survey about their experience being approached for the DIVI study, including questions about perceived respect and a validated scale to measure trust in medical researchers. Those who enroll in DIVI as well as those who decline to enroll in DIVI will be eligible to take the survey. The survey will also give them an opportunity to opt in to potentially be contacted for an interview, in which they will be asked open-ended questions about their experience being approached for the DIVI study.
DIVI study team members involved in recruitment. At or near the start of the DIVI study, the BRIEF team will obtain a list of contact information for each member of the DIVI team who will be involved in recruitment. The BRIEF team will contact each person individually to review and sign the BRIEF study consent form. The DIVI team will be asked to participate in the BRIEF educational module, which includes asynchronous and synchronous components, complete brief self-assessments of their consent discussions with families both before and after the intervention, and audio-record a subset of DIVI consent discussions so that the BRIEF team can assess fidelity to intervention components.

Conditions: Respect, Trust, Study Enrollment
Being tested: BRIEF Educational Module

What participants receive

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

BRIEF Educational ModuleBehavioural
The BRIEF Educational Module for research recruitment team members is intended to teach evidence-based approaches to improving participant experiences with research recruitment. It has three components: (1) asynchronous pre-work, including multimedia materials and an individual worksheet (approx. 30 min); (2) one synchronous in-person (or virtual if necessary) session, including didactics, discussions, and practice scenarios (approx. 90 min); and (3) an asynchronous, individual follow-up phone call to review individual questions (approx. 15 min).

Study groups in NCT04152603
Study group	Role	What they receive
Control Arm	No 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.
BRIEF Arm	Experimental	Enrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment after implementation of the BRIEF intervention. Receives: Behavioral: BRIEF Educational Module

What is being measured

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

Study Enrollment Rates
The BRIEF team will compare DIVI enrollment rates for the Neonate group before vs. after implementation of the BRIEF intervention.
Measured: Control Arm was assessed from baseline to the date of the intervention (pre-intervention) and the BRIEF Arm was assessed post-intervention to study completion (post-intervention), estimated at 14 months total (October 2022-December 2023).
Patient Trust in Research
The BRIEF team will compare parent/LAR-reported trust in research before vs. after implementation of the BRIEF intervention, using the validated 4-Item Trust in Medical Researchers scale described in Hall et al. 2008. Each item is scored on a 1-5 scale for a maximum score of 20 and a minimum score of 4, with higher scores indicating more trust. Scores are then indexed to a scale of 0-100, again with a higher rating indicating greater levels of trust.
Measured: Control Arm was assessed at baseline (pre-intervention) and the BRIEF Arm was assessed at study completion (post-intervention), estimated at 14 months (October 2022-December 2023).
Change in Patient Experiences of Respect During Research Recruitment
The BRIEF team will compare parent/LAR-reported experiences of being treated with respect during research recruitment before vs. after implementation of the BRIEF intervention. There is no relevant validated measure so this outcome will be measured using team-developed survey questions. Questions are measured on a Likert Scale, each item is scored on a 1-5 scale , with higher scores indicating greater perception of respect.
Measured: Control Arm was assessed at baseline (pre-intervention) and the BRIEF Arm was assessed at study completion (post-intervention), estimated at 14 months (October 2022-December 2023).

Timeline

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

10 Oct 202231 Dec 2023

First posted5 Nov 2019
Study start10 Oct 2022
Primary completion31 Dec 2023
Study completion31 Dec 2023

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for RespectStudies 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: Non-randomised
Intervention model: Parallel groups
Model description: The BRIEF Educational Module for research recruitment team members is intended to teach evidence-based approaches to improving participant experiences with research recruitment. It has three components: (1) asynchronous pre-work, including multimedia materials and an individual worksheet (approx. 30 min); (2) one synchronous in-person (or virtual if necessary) session, including didactics, discussions, and practice scenarios (approx. 90 min); and (3) an asynchronous, individual follow-up phone call to review individual questions (approx. 15 min).
Masking: None (open label)
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04152603
Sponsor's protocol ID: K01HG010361
Other IDs: K23HD103872
Acronym: BRIEF
Status last verified: Mar 2024
First submitted: 31 Oct 2019
Last updated: 28 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kraft SA, Duenas DM, Kelsh A, Oslin E, Gray MM, Juul SE, Weiss EM; BRIEF-DIVI Collaborative. Acceptability and Feasibility of an Educational Intervention to Improve Researcher-Participant Interactions in a Neonatal Intensive Care Unit Clinical Trial: Research Team Feedback on the BRIEF Intervention. Am J Perinatol. 2026 Sep;43(12):1678-1687. doi: 10.1055/a-2811-5163. Epub 2026 Feb 20.
PubMed 41720472

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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Better Research Interactions for Every Family
ClinicalTrials.gov ID: NCT04152603
Acronym / sponsor ID: BRIEF / K01HG010361
Conditions: Respect, Trust, Study Enrollment
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Seattle Children's HospitalUniversity, hospital or other
Collaborators: University of Washington, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 10 Oct 2022 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 5 Nov 2019 (actual)
Results: Posted 28 Mar 2024

Clinical summary

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

Detailed description

Neonates eligible for participation in the DIVI study, identified through the records of the DIVI team. Research activities for this group are limited to extraction of targeted demographic and clinical data from the medical record by the BRIEF study team.
Parents/legally authorized representatives (LARs) of infants approached for the DIVI study who will be invited to take a survey about their experience being approached for the DIVI study, including questions about perceived respect and a validated scale to measure trust in medical researchers. Those who enroll in DIVI as well as those who decline to enroll in DIVI will be eligible to take the survey. The survey will also give them an opportunity to opt in to potentially be contacted for an interview, in which they will be asked open-ended questions about their experience being approached for the DIVI study.
DIVI study team members involved in recruitment. At or near the start of the DIVI study, the BRIEF team will obtain a list of contact information for each member of the DIVI team who will be involved in recruitment. The BRIEF team will contact each person individually to review and sign the BRIEF study consent form. The DIVI team will be asked to participate in the BRIEF educational module, which includes asynchronous and synchronous components, complete brief self-assessments of their consent discussions with families both before and after the intervention, and audio-record a subset of DIVI consent discussions so that the BRIEF team can assess fidelity to intervention components.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The BRIEF Educational Module for research recruitment team members is intended to teach evidence-based approaches to improving participant experiences with research recruitment. It has three components: (1) asynchronous pre-work, including multimedia materials and an individual worksheet (approx. 30 min); (2) one synchronous in-person (or virtual if necessary) session, including didactics, discussions, and practice scenarios (approx. 90 min); and (3) an asynchronous, individual follow-up phone call to review individual questions (approx. 15 min).

Arm	Type	Receives
Control Arm	No 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.
BRIEF Arm	Experimental	Behavioral: BRIEF Educational ModuleEnrollment rates, parent/LAR-reported trust in research, and parent/LAR-reported experiences of respect during research recruitment after implementation of the BRIEF intervention.

Who may qualify

Ages: 0 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

None

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
BRIEF Educational ModuleThe BRIEF Educational Module for research recruitment team members is intended to teach evidence-based approaches to improving participant experiences with research recruitment. It has three components: (1) asynchronous pre-work, including multimedia materials and an individual worksheet (approx. 30 min); (2) one synchronous in-person (or virtual if necessary) session, including didactics, discussions, and practice scenarios (approx. 90 min); and (3) an asynchronous, individual follow-up phone call to review individual questions (approx. 15 min).	Behavioural	BRIEF Arm

Primary outcome

Study Enrollment Rates
Time frame: Control Arm was assessed from baseline to the date of the intervention (pre-intervention) and the BRIEF Arm was assessed post-intervention to study completion (post-intervention), estimated at 14 months total (October 2022-December 2023).
The BRIEF team will compare DIVI enrollment rates for the Neonate group before vs. after implementation of the BRIEF intervention.
Patient Trust in Research
Time frame: Control Arm was assessed at baseline (pre-intervention) and the BRIEF Arm was assessed at study completion (post-intervention), estimated at 14 months (October 2022-December 2023).
The BRIEF team will compare parent/LAR-reported trust in research before vs. after implementation of the BRIEF intervention, using the validated 4-Item Trust in Medical Researchers scale described in Hall et al. 2008. Each item is scored on a 1-5 scale for a maximum score of 20 and a minimum score of 4, with higher scores indicating more trust. Scores are then indexed to a scale of 0-100, again with a higher rating indicating greater levels of trust.
Change in Patient Experiences of Respect During Research Recruitment
Time frame: Control Arm was assessed at baseline (pre-intervention) and the BRIEF Arm was assessed at study completion (post-intervention), estimated at 14 months (October 2022-December 2023).
The BRIEF team will compare parent/LAR-reported experiences of being treated with respect during research recruitment before vs. after implementation of the BRIEF intervention. There is no relevant validated measure so this outcome will be measured using team-developed survey questions. Questions are measured on a Likert Scale, each item is scored on a 1-5 scale , with higher scores indicating greater perception of respect.

Results and safety

Results posted to the registry on 28 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Arm	52	52
BRIEF Arm	77	77
DIVI Study Team	9	9

Primary outcome: Study Enrollment Rates

Time frame: Control Arm was assessed from baseline to the date of the intervention (pre-intervention) and the BRIEF Arm was assessed post-intervention to study completion (post-intervention), estimated at 14 months total (October 2022-December 2023).. Count of participants. Unit: Participants

Measure	Control Arm n = 33	BRIEF Arm n = 56
Enrolled in DIVI	13	24
Not Enrolled in DIVI	20	32

Population analysed: Number of BRIEF participants across the Control and BRIEF arms that either enrolled in the DIVI study or did not enroll in the DIVI study (neonates only).

Primary outcome: Patient Trust in Research

Time frame: Control Arm was assessed at baseline (pre-intervention) and the BRIEF Arm was assessed at study completion (post-intervention), estimated at 14 months (October 2022-December 2023).. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Arm n = 19	BRIEF Arm n = 21
Value	78 (18)	77 (11)

Population analysed: Parents/LARs only.

Primary outcome: Change in Patient Experiences of Respect During Research Recruitment

Measure	Control Arm n = 19	BRIEF Arm n = 21
Value	4.36 (2 to 5)	4.76 (4 to 5)

Population analysed: Parents/LARs only.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Arm	0 of 28 (0%)	0 of 28 (0%)	0 of 28
BRIEF Arm	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): Due to limitations experienced by the partner clinical trial, we were unable to meet our desired recruitment goals for Spanish-speaking participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41720472Kraft SA, Duenas DM, Kelsh A, Oslin E, Gray MM, Juul SE, Weiss EM; BRIEF-DIVI Collaborative. Acceptability and Feasibility of an Educational Intervention to Improve Researcher-Participant Interactions in a Neonatal Intensive Care Unit Clinical Trial: Research Team Feedback on the BRIEF Intervention. Am J Perinatol. 2026 Sep;43(12):1678-1687. doi: 10.1055/a-2811-5163. Epub 2026 Feb 20.

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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.

Stephanie A Kraft, JD principal investigator

Seattle Children's Hospital

Elliott M Weiss, MD, MSME principal investigator

Seattle Children's Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing BRIEF Educational Module in people with Respect and Trust, run by Seattle Children's Hospital 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 3 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 28 Mar 2024. 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 28 Mar 2024). 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?

Study Enrollment Rates (time frame: Control Arm was assessed from baseline to the date of the intervention (pre-intervention) and the BRIEF Arm was assessed post-intervention to study completion (post-intervention), estimated at 14 months total (October 2022-December 2023).). The study lists 3 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 NCT04152603, which also lists 1 linked publication.

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 28 Mar 2024.