Prader-Willi SyndromeNCT00808548
Exploring Stress and Coping Behaviors of the Major Carer Whose Children With Prader-Willi Syndrome
An observational study of Prader-Willi Syndrome, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Ask the 4 carers of children with Prader-willi syndrome to disclose their experiences and difficulties for searching better management and intervention Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- counseling, emotional support and emotional support
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2008to Dec 2009
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: a person who care and live with childre with Prader-Willi syndrome
Who may be able to join
- a person who care and live with children with Prader-Willi syndrome
Who cannot join
- siblings or less-contact family
- teachers
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taichung Veterans General Hospital
Taichung, 40707
shu chien, 04-25392525 ext. 5938, shuch@vghtc.gov.tw
About this study
Ask the 4 carers of children with Prader-willi syndrome to disclose their experiences and difficulties for searching better management and intervention
- Conditions
- Prader-Willi Syndrome
- Being tested
- counseling, emotional support, emotional support
- Keywords
- stress, carer's experiences, Prader-willi syndrome, personal experiences
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling, emotional supportOther
emotional supportOther
emotional support during the interview
emotional supportOther
emotional supporting during the interview
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Not described Receives: Other: counseling, emotional support; Other: emotional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
experience
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808548
- Sponsor's protocol ID
- C08169
- Status last verified
- Dec 2008
- First submitted
- 15 Dec 2008
- Last updated
- 16 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Stress and Coping Behaviors of the Major Carer Whose Children With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT00808548
- Acronym / sponsor ID
- C08169
- Conditions
- Prader-Willi Syndrome
- Keywords
- stress, carer's experiences, Prader-willi syndrome, personal experiences
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 16 Dec 2008 (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.
Ask the 4 carers of children with Prader-willi syndrome to disclose their experiences and difficulties for searching better management and intervention
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | – | Other: counseling, emotional support, Other: emotional support |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- a person who care and live with childre with Prader-Willi syndrome
Key inclusion criteria (1 listed)
- a person who care and live with children with Prader-Willi syndrome
Key exclusion criteria (2 listed)
- siblings or less-contact family
- teachers
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 |
|---|---|---|
| counseling, emotional support | Other | Lifestyle counseling |
| emotional supportemotional support during the interview | Other | Lifestyle counseling |
| emotional supportemotional supporting during the interview | Other | Lifestyle counseling |
Primary outcome
experience
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2008.
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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.
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 Prader-Willi Syndrome, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Dec 2008. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
experience (time frame: one year). It is what the study was designed to measure, not a finding.
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 16 Dec 2008.