Tweens to Teens Project at Penn State

Congenital Adrenal Hyperplasia Clinical Trial

— T2T@PSU  

Official title:

"Gender Development in Early Adolescence: Prenatal Hormones and Family Socialization"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184651
• Other study ID #: PSU ORP#30695
• Secondary ID: 1R01HD057930-01A
• Status: Completed
• Phase: N/A
• First received: August 2, 2010
• Last updated: January 4, 2018
• Start date: August 2009
• Est. completion date: July 2013

Study information

• Verified date: January 2018
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenocortical Hyperfunction
• Adrenogenital Syndrome
• Congenital Adrenal Hyperplasia
• Hyperplasia

Intervention

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 .
• 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.

Locations

Country	Name	City	State
United States	The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States,