Adaptation Among Adolescents and Adults With Klinefelter Syndrome

Klinefelter Syndrome Clinical Trial

Official title:

Adaptation Among Adolescents and Adults With Klinefelter Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896272
• Other study ID #: 999909142
• Secondary ID: 09-HG-N142
• Status: Completed
• Start date: May 5, 2009
• Est. completion date: January 13, 2015

Study information

• Verified date: January 13, 2015
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to understand the impact of living with Klinefelter syndrome (KS) and the factors that contribute to adaptation in adolescents and adults. Individuals with KS may have variable symptoms, including hypogonadism, gynecomastia, learning disabilities, and delay and underdevelopment of secondary sexual characteristics. Perhaps the most challenging symptom of KS is infertility, which seems to be a universal symptom. It is not fully understood how males with KS conceptualize their condition, cope with their diagnosis, and adapt to living with this condition. In this study, Lazarus and Folkman s Transactional Model of Stress and Coping provides a framework for examining coping and adaptation in males with KS. A cross-sectional research design using a quantitative survey will be utilized to examine the relationships among appraisals (illness perceptions and perceived stigma), time elapsed since learning of diagnosis, coping, and adaptation. Adolescents and adults with KS will be recruited from national KS support networks via website postings, email listservs, and printed newsletter postings. Adolescents will also be recruited from a private practice. Participants will have the option to complete an online or paper version of the survey. The main outcome variable is adaptation to living with a KS diagnosis.

Description:

This study aims to understand the impact of living with Klinefelter syndrome (KS) and the factors that contribute to adaptation in adolescents and adults. Individuals with KS may have variable symptoms, including hypogonadism, gynecomastia, learning disabilities, and delay and underdevelopment of secondary sexual characteristics. Perhaps the most challenging symptom of KS is infertility, which seems to be a universal symptom. It is not fully understood how males with KS conceptualize their condition, cope with their diagnosis, and adapt to living with this condition. In this study, Lazarus and Folkman s Transactional Model of Stress and Coping provides a framework for examining coping and adaptation in males with KS. A cross-sectional research design using a quantitative survey will be utilized to examine the relationships among appraisals (illness perceptions and perceived stigma), time elapsed since learning of diagnosis, coping, and adaptation. Adolescents and adults with KS will be recruited from national KS support networks via website postings, email listservs, and printed newsletter postings. Adolescents will also be recruited from a private practice. Participants will have the option to complete an online or paper version of the survey. The main outcome variable is adaptation to living with a KS diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: January 13, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 14 Years to 80 Years

Eligibility

• INCLUSION CRITERIA:

1. Must have Klinefelter syndrome (47,XXY) by self-report.

2. Must be 14 years or older.

Related Conditions & MeSH terms

• Klinefelter Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	National Human Genome Research Institute (NHGRI), 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Abramsky L, Chapple J. 47,XXY (Klinefelter syndrome) and 47,XYY: estimated rates of and indication for postnatal diagnosis with implications for prenatal counselling. Prenat Diagn. 1997 Apr;17(4):363-8. — View Citation

Bender BG, Harmon RJ, Linden MG, Robinson A. Psychosocial adaptation of 39 adolescents with sex chromosome abnormalities. Pediatrics. 1995 Aug;96(2 Pt 1):302-8. — View Citation

Biesecker BB, Erby L. Adaptation to living with a genetic condition or risk: a mini-review. Clin Genet. 2008 Nov;74(5):401-7. doi: 10.1111/j.1399-0004.2008.01088.x. Epub 2008 Sep 24. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adaptation to Klinefelter. The primary research question is to answer how adolescents and adults adapt to Klinefelter syndrome.
Secondary	Open ended questions will also assess most difficult and best aspects of living with the condition. Follow-up research will be aimed at opportunities for enhancing adaptation.