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CompletedNCT01184651T2T@PSUUpdated Jan 8, 2018

Tweens to Teens Project at Penn State

An observational study in Congenital Adrenal Hyperplasia, sponsored by Penn State University. Completed at 1 site in United States. Open to female participants aged 10 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-08.

Sponsored by Penn State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
188
Ages
10 Years to 13 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Congenital Adrenal Hyperplasia

Keywords

  • Congenital Adrenal Hyperplasia
  • CAH
  • sex differences
  • adolescence
  • androgen
  • behavior
  • gender development
03

In context

Adrenal Hyperplasia, Congenital

107 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 29 are open to participants now.

This study's enrollment of 188 is above the median of 60 across 45 observational studies indexed under Adrenal Hyperplasia, Congenital.

Browse Adrenal Hyperplasia, Congenital studies →

Lead sponsor

Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 13 Years
Sexes eligible
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
188 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • BehavioralQuestionnaires/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 .

  • BehavioralQuestionnaires/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.

06

Study locations

1 site
  • The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project
    University Park, Pennsylvania 16802, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01184651
Lead sponsor
Penn State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sheri Berenbaum (Professor of Psychology and Pediatrics, Penn State University) — Principal investigator
First posted
Aug 19, 2010
Start date
Aug 2009
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jan 8, 2018

Study contacts

Sheri A Berenbaum, PhD
principal investigator · The Pennsylvania State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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