Trial record 1 of 1 for:    NCT01184651
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Tweens to Teens Project at Penn State (T2T@PSU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01184651
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : January 8, 2018
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sheri Berenbaum, Penn State University

August 2, 2010
August 19, 2010
January 8, 2018
August 2009
July 2013   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01184651 on Archive Site
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Tweens to Teens Project at Penn State
"Gender Development in Early Adolescence: Prenatal Hormones and Family Socialization"
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.

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.

Observational Model: Cohort
Time Perspective: Cross-Sectional
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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.
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.
Congenital Adrenal Hyperplasia
  • 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 .
  • 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.
  • Girls
    Girls with 21-hydroxylase deficiency (21-OHD) congenital adrenal hyperplasia (CAH) ages 10-13
    Intervention: Behavioral: Questionnaires/Interviews
  • Parents
    Parent, guardian, or significant caretaker of girls with CAH
    Intervention: Behavioral: Questionnaires/Interviews
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
10 Years to 13 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
PSU ORP#30695
1R01HD057930-01A1 ( U.S. NIH Grant/Contract )
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Sheri Berenbaum, Penn State University
Penn State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Sheri A Berenbaum, PhD The Pennsylvania State University
Penn State University
January 2018