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

Huntington Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421327
• Other study ID #: IRB00121662
• Secondary ID: R01HG008045
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Hereditary Breast and Ovarian Cancer
• Hereditary Breast and Ovarian Cancer Syndrome
• Hereditary Cancer
• Hereditary Non-polyposis Colon Cancer
• Hereditary Non-Polyposis Colorectal Cancer Syndrome
• Huntington Disease

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

References & Publications (13)

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Janghorban R, Latifnejad Roudsari R, Taghipour A. Skype interviewing: the new generation of online synchronous interview in qualitative research. Int J Qual Stud Health Well-being. 2014 Apr 15;9:24152. doi: 10.3402/qhw.v9.24152. eCollection 2014. Review. — View Citation

Jarvik GP, Amendola LM, Berg JS, Brothers K, Clayton EW, Chung W, Evans BJ, Evans JP, Fullerton SM, Gallego CJ, Garrison NA, Gray SW, Holm IA, Kullo IJ, Lehmann LS, McCarty C, Prows CA, Rehm HL, Sharp RR, Salama J, Sanderson S, Van Driest SL, Williams MS, Wolf SM, Wolf WA; eMERGE Act-ROR Committee and CERC Committee; CSER Act-ROR Working Group, Burke W. Return of genomic results to research participants: the floor, the ceiling, and the choices in between. Am J Hum Genet. 2014 Jun 5;94(6):818-26. doi: 10.1016/j.ajhg.2014.04.009. Epub 2014 May 8. — View Citation

McConkie-Rosell A, Spiridigliozzi GA, Melvin E, Dawson DV, Lachiewicz AM. Living with genetic risk: effect on adolescent self-concept. Am J Med Genet C Semin Med Genet. 2008 Feb 15;148C(1):56-69. doi: 10.1002/ajmg.c.30161. — View Citation

Meropol NJ, Daly MB, Vig HS, Manion FJ, Manne SL, Mazar C, Murphy C, Solarino N, Zubarev V. Delivery of Internet-based cancer genetic counselling services to patients' homes: a feasibility study. J Telemed Telecare. 2011;17(1):36-40. doi: 10.1258/jtt.2010.100116. Epub 2010 Nov 19. — View Citation

Quarrell OW, Rigby AS, Barron L, Crow Y, Dalton A, Dennis N, Fryer AE, Heydon F, Kinning E, Lashwood A, Losekoot M, Margerison L, McDonnell S, Morrison PJ, Norman A, Peterson M, Raymond FL, Simpson S, Thompson E, Warner J. Reduced penetrance alleles for Huntington's disease: a multi-centre direct observational study. J Med Genet. 2007 Mar;44(3):e68. — View Citation

Smith LA, Ullmann JF, Olson HE, Achkar CM, Truglio G, Kelly M, Rosen-Sheidley B, Poduri A. A Model Program for Translational Medicine in Epilepsy Genetics. J Child Neurol. 2017 Mar;32(4):429-436. doi: 10.1177/0883073816685654. Epub 2017 Jan 6. — View Citation

Trondsen MV, Bolle SR, Stensland GØ, Tjora A. Video-confidence: a qualitative exploration of videoconferencing for psychiatric emergencies. BMC Health Serv Res. 2014 Oct 31;14:544. doi: 10.1186/s12913-014-0544-y. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative analysis of how parents and children with either Huntington's Disease or hereditary cancer communicate about genetic risk information	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.	1.5 years