Tweens to Teens Project at Penn State (T2T@PSU)
Recruitment status was Recruiting
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Purpose
The goal of this study is to help investigators to understand more about the development of characteristics related to being male or female (what is called gender development). The investigators will study girls with congenital adrenal hyperplasia (CAH) aged 10 to 13 to learn more about the girls' interests and activities, thoughts and feeling about being female, and family relationships. This will help investigators to understand the ways in which gender development is shaped by hormones and family relationships.
| Condition | Intervention |
|---|---|
|
Congenital Adrenal Hyperplasia |
Behavioral: Questionnaires/Interviews |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | "Gender Development in Early Adolescence: Prenatal Hormones and Family Socialization" |
Samples of saliva will be collected from participants with CAH for genetic testing (specific mutations of CYP21 gene) and to obtain hormone levels.
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Girls
Girls with 21-hydroxylase deficiency (21-OHD) congenital adrenal hyperplasia (CAH) ages 10-13
|
Behavioral: Questionnaires/Interviews
Girls answer questions about activities and interests, school, feelings about being a girl, stage of physical development, and family relationships during a home interview , provide saliva samples, and participate in phone interviews to answer questions about daily activities .
|
|
Parents
Parent, guardian, or significant caretaker of girls with CAH
|
Behavioral: Questionnaires/Interviews
Parents complete questionnaires about their daughter's activities, interests, and behaviors, educational goals, family demographics and relationships, grades, diagnosis and treatment of her CAH, their own activities, interests, and thoughts and feelings about being male or female. Parents answer questions during phone interviews about their daughters daily activities.
|
Detailed Description:
Interviewers will visit girls in their home when it is convenient for the family. Girls will answer questions about the things they do and are interested in, how they think and feel, and complete some cognitive tasks. Girls will also provide saliva so we can examine their hormones and determine the CAH gene mutation they have. Parents will also be asked to complete questionnaires about their own activities and interests and about their daughter's behavior.
Shortly after the home visit, interviewers will telephone girls and their parents on several days and ask what the girls did during the day.
Eligibility| Ages Eligible for Study: | 10 Years to 13 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
We will study girls with the 21-hydroxylase deficiency (21-OHD) form of congenital adrenal hyperplasia (CAH) aged 10 to 13. Parents of participants are also included.
Inclusion Criteria:
- Girls with classical or non-classical CAH due to 21-OHD
- Girls will be aged 10-13 years at initial recruitment
- Parents will include biological mothers and fathers as well as step-parents and/or other guardians/significant caregivers
- Parents/guardians may range in age from 18 years of age to 65 years of age.
Exclusion Criteria:
- Girls who are not within the age range of 10-13 years old at initial recruitment
- CAH not due to the 21-OHD form
Contacts and Locations| Contact: Tweens to Teens Project @ Penn State | 814-933-6438 | T2TProject@psu.edu |
| United States, Pennsylvania | |
| The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project | Recruiting |
| University Park, Pennsylvania, United States, 16802 | |
| Contact: Sheri A Berenbaum, PhD 814-865-6140 sab31@psu.edu | |
| Contact: Kristina Bryk, MSW 814-933-6438 T2TProject@psu.edu | |
| Principal Investigator: | Sheri A Berenbaum, PhD | The Pennsylvania State University |
More Information
No publications provided
| Responsible Party: | Dr.Sheri A. Berenbaum, Department of Psychology, The Pennsylvania State University |
| ClinicalTrials.gov Identifier: | NCT01184651 History of Changes |
| Other Study ID Numbers: | PSU ORP#30695, 1R01HD057930-01A1 |
| Study First Received: | August 2, 2010 |
| Last Updated: | August 23, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Penn State University:
|
Congenital Adrenal Hyperplasia CAH sex differences adolescence |
androgen behavior gender development |
Additional relevant MeSH terms:
|
Adrenal Hyperplasia, Congenital Adrenogenital Syndrome Hyperplasia Congenital Abnormalities Adrenal Gland Diseases Adrenocortical Hyperfunction Disorders of Sex Development Urogenital Abnormalities |
Genetic Diseases, Inborn Steroid Metabolism, Inborn Errors Metabolism, Inborn Errors Metabolic Diseases Endocrine System Diseases Gonadal Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013