Tweens to Teens Project at Penn State

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.

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Key information

Conditions

Congenital Adrenal Hyperplasia Adrenal Gland Diseases Adrenal Hyperplasia, Congenital Adrenogenital Syndrome Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Steroid Metabolism, Inborn Errors Urogenital Abnormalities Urogenital Diseases

Age range

10 year–13 year

Sex eligibility

Female

Study type

Observational

Primary location

The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires/Interviews

Behavioral

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 .

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: T2T@PSU

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Aug 19, 2010
Registry last updated: Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed