Congenital Adrenal HyperplasiaT2T@PSUNCT01184651
Tweens to Teens Project at Penn State
An observational study of Congenital Adrenal Hyperplasia, run by Penn State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Adrenal Hyperplasia
- What is being tested?
- Questionnaires/Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- Women only
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Girls who are not within the age range of 10-13 years old at initial recruitment
- CAH not due to the 21-OHD form
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University, Dept. of Psychology - Tweens to Teens Project
University Park, Pennsylvania, 16802
About this study
Official title: "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.
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.
- Conditions
- Congenital Adrenal Hyperplasia
- Being tested
- Questionnaires/Interviews
- Keywords
- Congenital Adrenal Hyperplasia, CAH, sex differences, adolescence, androgen, behavior, gender development
- Medical subject headings
- Adrenal Hyperplasia, Congenital, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires/InterviewsBehavioural
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 .
Questionnaires/InterviewsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Girls | Girls with 21-hydroxylase deficiency (21-OHD) congenital adrenal hyperplasia (CAH) ages 10-13 Receives: Behavioral: Questionnaires/Interviews | |
| Parents | Parent, guardian, or significant caretaker of girls with CAH Receives: Behavioral: Questionnaires/Interviews |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sheri Berenbaum, Penn State University
- Investigators
- Sheri A Berenbaum, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184651
- Sponsor's protocol ID
- PSU ORP#30695
- Other IDs
- 1R01HD057930-01A1
- Acronym
- T2T@PSU
- Status last verified
- Jan 2018
- First submitted
- 2 Aug 2010
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Gender Development in Early Adolescence: Prenatal Hormones and Family Socialization"
- ClinicalTrials.gov ID
- NCT01184651
- Acronym / sponsor ID
- T2T@PSU / PSU ORP#30695
- Conditions
- Congenital Adrenal Hyperplasia
- Keywords
- Congenital Adrenal Hyperplasia, CAH, sex differences, adolescence, androgen, behavior, gender development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Girls | – | Behavioral: Questionnaires/InterviewsGirls with 21-hydroxylase deficiency (21-OHD) congenital adrenal hyperplasia (CAH) ages 10-13 |
| Parents | – | Behavioral: Questionnaires/InterviewsParent, guardian, or significant caretaker of girls with CAH |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Girls who are not within the age range of 10-13 years old at initial recruitment
- CAH not due to the 21-OHD form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires/InterviewsGirls 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 . | Behavioural | Girls |
| Questionnaires/InterviewsParents 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. | Behavioural | Parents |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheri A Berenbaum, PhD principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Adrenal Hyperplasia, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.