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Tweens to Teens Project at Penn State (T2T@PSU)

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ClinicalTrials.gov Identifier: NCT01184651
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : January 8, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sheri Berenbaum, Penn State University

Brief Summary:
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 or disease Intervention/treatment
Congenital Adrenal Hyperplasia Behavioral: Questionnaires/Interviews

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.


Study Type : Observational
Actual Enrollment : 188 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: "Gender Development in Early Adolescence: Prenatal Hormones and Family Socialization"
Study Start Date : August 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013


Group/Cohort Intervention/treatment
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.



Biospecimen Retention:   Samples With DNA
Samples of saliva will be collected from participants with CAH for genetic testing (specific mutations of CYP21 gene) and to obtain hormone levels.


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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

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): NCT01184651


Locations
United States, Pennsylvania
The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Sheri A Berenbaum, PhD The Pennsylvania State University

Responsible Party: Sheri Berenbaum, Professor of Psychology and Pediatrics, Penn State University
ClinicalTrials.gov Identifier: NCT01184651     History of Changes
Other Study ID Numbers: PSU ORP#30695
1R01HD057930-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Sheri Berenbaum, Penn State University:
Congenital Adrenal Hyperplasia
CAH
sex differences
adolescence
androgen
behavior
gender development

Additional relevant MeSH terms:
Hyperplasia
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders