T2T@PSU: Tweens to Teens Project at Penn State

Sponsor

Penn State University (Other)

Overall Status

Completed

CT.gov ID

NCT01184651

Collaborator

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

188

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Congenital Adrenal Hyperplasia	Behavioral: Questionnaires/Interviews 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 Design

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 :

Aug 1, 2009

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 13 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.