Trial record 8 of 26 for:    CAH

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Penn State University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT01184651
First received: August 2, 2010
Last updated: August 23, 2010
Last verified: May 2010
  Purpose

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 Intervention
Congenital Adrenal Hyperplasia
Behavioral: Questionnaires/Interviews

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: "Gender Development in Early Adolescence: Prenatal Hormones and Family Socialization"

Resource links provided by NLM:


Further study details as provided by Penn State University:

Biospecimen Retention:   Samples With DNA

Samples of saliva will be collected from participants with CAH for genetic testing (specific mutations of CYP21 gene) and to obtain hormone levels.


Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 13 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184651

Contacts
Contact: Tweens to Teens Project @ Penn State 814-933-6438 T2TProject@psu.edu

Locations
United States, Pennsylvania
The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Sheri A Berenbaum, PhD    814-865-6140    sab31@psu.edu   
Contact: Kristina Bryk, MSW    814-933-6438    T2TProject@psu.edu   
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Sheri A Berenbaum, PhD The Pennsylvania State University
  More Information

No publications provided

Responsible Party: Dr.Sheri A. Berenbaum, Department of Psychology, The Pennsylvania State University
ClinicalTrials.gov Identifier: NCT01184651     History of Changes
Other Study ID Numbers: PSU ORP#30695, 1R01HD057930-01A1
Study First Received: August 2, 2010
Last Updated: August 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Congenital Adrenal Hyperplasia
CAH
sex differences
adolescence
androgen
behavior
gender development

Additional relevant MeSH terms:
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Hyperplasia
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014