Tweens to Teens Project at Penn State (T2T@PSU)

"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.

Study Overview

• Status: Completed
• Conditions: Congenital Adrenal Hyperplasia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 188

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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 .; 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.
Parents; Parent, guardian, or significant caretaker of girls with CAH	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.

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Sheri A Berenbaum, PhD, The Pennsylvania State University

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 2, 2010
• First Submitted That Met QC Criteria: August 18, 2010
• First Posted (Estimate): August 19, 2010

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: sex differences; behavior; Congenital Adrenal Hyperplasia; adolescence; CAH; androgen; gender development
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Adrenal Gland Diseases; Steroid Metabolism, Inborn Errors; Hyperplasia; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome
• Other Study ID Numbers: PSU ORP#30695; 1R01HD057930-01A1 (U.S. NIH Grant/Contract)