Tweens to Teens Project at Penn State

Completed

• Conditions: Congenital Adrenal Hyperplasia
• Interventions: Behavioral: Questionnaires/Interviews

• Registration Number: NCT01184651
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 188

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Girls	Questionnaires/Interviews	Girls with 21-hydroxylase deficiency (21-OHD) congenital adrenal hyperplasia (CAH) ages 10-13
Parents	Questionnaires/Interviews	Parent, guardian, or significant caretaker of girls with CAH

Trial Locations

Locations (1)

The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project; 🇺🇸 University Park, Pennsylvania, United States