NCT01184651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 2, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

3.9 years

First QC Date

August 2, 2010

Last Update Submit

January 4, 2018

Conditions

Keywords

Congenital Adrenal HyperplasiaCAHsex differencesadolescenceandrogenbehaviorgender development

Study Arms (2)

Girls

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

Behavioral: Questionnaires/Interviews

Parents

Parent, guardian, or significant caretaker of girls with CAH

Behavioral: Questionnaires/Interviews

Interventions

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 .

Girls

Eligibility Criteria

Age10 Years - 13 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Girls who are not within the age range of 10-13 years old at initial recruitment
  • CAH not due to the 21-OHD form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

University Park, Pennsylvania, 16802, United States

Location

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.

MeSH Terms

Conditions

Adrenal Hyperplasia, CongenitalBehavior

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Adrenogenital SyndromeDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornSteroid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAdrenal Gland DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sheri A Berenbaum, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology and Pediatrics

Study Record Dates

First Submitted

August 2, 2010

First Posted

August 19, 2010

Study Start

August 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations