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Genetic Risk: Whether, When, and How to Tell Adolescents

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ClinicalTrials.gov Identifier: NCT03421327
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study is being conducted to learn more about family communication of genetic risk information. Semi-structured interviews lasting up to one hour will be conducted with three populations: parent/child pairs at risk for Huntington's Disease, parent/child pairs at risk for hereditary cancer, and genetic counselors.

Condition or disease
Huntington Disease Hereditary Breast and Ovarian Cancer Hereditary Cancer Hereditary Non-polyposis Colon Cancer Hereditary Non-Polyposis Colorectal Cancer Syndrome

Detailed Description:

The investigators currently lack an adequate understanding of how parents and children feel about genetic risk/status, how it is communicated, and how it influences wellbeing and family relationships. This understanding is vital in order for genetic counselors and other health care professionals to provide the best guidance possible to families. However, little research has been conducted on the impact of genetic risk information or testing on children from the perspective of the child. The research proposed here is uniquely positioned to help fill this gap.

For this study, the investigators will interview 15-20 parent/child pairs who are at risk for Huntington's Disease (HD), 15-20 parent/child pairs who are at risk for hereditary cancer, and 15-20 certified genetic counselors. Interviews will last no more than one hour and will be conducted at a time and place that is convenient for the participant. The investigators will offer participants a choice of conducting the interview in a private conference room at the Berman Institute of Bioethics, or remotely by Skype or telephone. Parents and children will be interviewed separately. Parents will be asked about the decision process behind how and when they disclosed genetic information to their child, style of family communication, advice for other parents in similar situations, and other questions related to the subject of communication of genetic information to minors. Children will be asked about their experience learning genetic risk information, style of family communication, how they felt, advice for other kids in similar situations, and other questions related to the subject of communication of genetic information to minors.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genetic Risk: Whether, When, and How to Tell Adolescents
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


Group/Cohort
Families at-risk for HD
No interventions will be administered. Participation involves one semi-structured interview that will last up to one hour. The interview will be scheduled at a time and place that is convenient for the participant. The participant will be given the option to conduct the interview via phone, Skype, or in-person at Johns Hopkins.
Families at-risk for hereditary cancer
No interventions will be administered. Participation involves one semi-structured interview that will last up to one hour. The interview will be scheduled at a time and place that is convenient for the participant. The participant will be given the option to conduct the interview via phone, Skype, or in-person at Johns Hopkins.
Genetic Counselors
No interventions will be administered. Participation involves one semi-structured interview that will last up to one hour. The interview will be scheduled at a time and place that is convenient for the participant. The participant will be given the option to conduct the interview via phone, Skype, or in-person at Johns Hopkins.



Primary Outcome Measures :
  1. Qualitative analysis of how parents and children with either Huntington's Disease or hereditary cancer communicate about genetic risk information [ Time Frame: 1.5 years ]
    Qualitative interview performed at one occasion where the patient describes when and how genetic risk information was disclosed to minor as well as perspectives from both parent and child.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will include individuals who reside in the USA, speak English, and are able to participate in one interview either in person, via phone, or via Skype.
Criteria

Inclusion Criteria:

  • Parents at-risk for HD, affected by HD, or be the spouse/partner of someone living who at risk for or affected by HD.
  • Parents who have or have had a diagnosis of hereditary cancer, or the spouse/partner of someone living who has or has had had a diagnosis of hereditary cancer.
  • Children ages 15-17 who are at risk for either HD or hereditary cancer

Exclusion Criteria:

  • Parents and children who have not yet communicated about genetic risk
  • Children younger than age 15

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421327


Contacts
Contact: Kelsey Stuttgen, BS 410-614-5581 kstuttgen@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Kelsey Stuttgen, BS    410-614-5581    kstuttgen@jhmi.edu   
Principal Investigator: Debra Mathews, PhD, MA         
Sponsors and Collaborators
Johns Hopkins University
National Human Genome Research Institute (NHGRI)
Investigators
Principal Investigator: Debra Mathews, PhD, MA Johns Hopkins Berman Institute of Bioeithics

Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03421327     History of Changes
Other Study ID Numbers: IRB00121662
R01HG008045 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Huntington Disease
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Breast Diseases
Skin Diseases
Endocrine System Diseases
Gonadal Disorders
DNA Repair-Deficiency Disorders
Metabolic Diseases
Colorectal Neoplasms
Hereditary Breast and Ovarian Cancer Syndrome
Colorectal Neoplasms, Hereditary Nonpolyposis