Tweens to Teens Project at Penn State

NCT ID: NCT01184651

Last Updated: 2018-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Congenital Adrenal Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Girls

Girls with 21-hydroxylase deficiency (21-OHD) congenital adrenal hyperplasia (CAH) ages 10-13

Questionnaires/Interviews

Intervention Type 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 .

Parents

Parent, guardian, or significant caretaker of girls with CAH

Questionnaires/Interviews

Intervention Type BEHAVIORAL

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.

Interventions

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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 .

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Sheri Berenbaum

Professor of Psychology and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheri A Berenbaum, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

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

University Park, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1R01HD057930-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PSU ORP#30695

Identifier Type: -

Identifier Source: org_study_id

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