Completed

Psychosocial Aspects in Genetic Counseling

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Study Aim

This study aims to observe and understand the emotional and social experiences of individuals receiving genetic counseling by examining their self-perception, communication, and emotional responses.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 18 to 115 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2024
See protocol details

Summary

Principal SponsorNational Human Genome Research Institute (NHGRI)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 26, 2024

Actual date on which the first participant was enrolled.

This study focuses on understanding the practice of genetic counseling at the National Institutes of Health (NIH). Genetic counseling is a field that helps individuals understand and adapt to the medical, psychological, and familial implications of genetic contributions to disease. The study aims to observe how genetic counselors discuss and provide psychosocial care, which involves addressing the emotional and social aspects of health. By studying the interactions in genetic counseling sessions and conversations among counseling teams, researchers hope to highlight how these professionals manage the emotional aspects of genetic risk, diagnosis, and prognosis. The findings could lead to a better understanding of the role of genetic counselors in the broader healthcare system, ultimately improving the support they provide to patients. The study involves two main parts. First, a researcher will observe genetic counseling sessions and team meetings to take detailed notes on the interactions and strategies used by counselors. This will help capture how they handle conversations around risk, emotional responses, and counseling methods. In the second part, about 20 participants from the initial observations will be interviewed to gain more insights into their experiences and views. These interviews will last around an hour, and the audio will be recorded and transcribed for analysis. The collected data will be organized into a codebook to identify common themes like how counselors perceive themselves and discuss psychosocial care and emotions related to genetic risks.

Official TitleCare Choreographies and the Making of the Psychosocial in Genetic Counseling
NCT06280833
Principal SponsorNational Human Genome Research Institute (NHGRI)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 115 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

* INCLUSION CRITERIA: To be eligible for this protocol, participants must be genetic counselors currently practicing at NIH, be a clinical colleague of these genetic counselors, be a patient having a session with one of the aforementioned genetic counselors, and be at least 18 years of age. For Phase I (direct observation), we will aim to recruit genetic counselors from at least one clinical team at NIH. For Phase II (open-ended interviews), we will recruit approximately 20 NIH staff members from those in Phase I for interviews. Potential participants for Phase II will be recruited through a purposive sampling approach, identified for their expertise in the psychological or social dimensions of clinical genetics. Potential participants will include participants in Phase I but will also include potential interviewees of interest who were not observed in Phase I. We anticipate concluding enrollment by June 2024. EXCLUSION CRITERIA: Anyone who is under 18, is neither a genetic counselor (or those with whom they have genetic counseling sessions) nor allied health professional, or is unable to provide consent, will not be included in the protocol.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Human Genome Research Institute (NHGRI)

Bethesda, United StatesOpen National Human Genome Research Institute (NHGRI) in Google Maps
CompletedOne Study Center