Exploring Stress and Coping Behaviors of the Major Carer... | NCT00808548

Studies
Exploring Stress and Coping Behaviors of the Major Carer Whose Children With Prader-Willi Syndrome

NCT00808548

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Dec 16, 2008Estimated

Enrollment

8Estimated

Phase

Not provided

Conditions

Prader-Willi Syndrome

Interventions

counseling, emotional support
emotional support
emotional support

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Feb 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Dec 15, 2008

First Submission Date that Met QC Criteria

Dec 15, 2008

First Posted Date

Dec 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2008

Last Update Posted Date

Dec 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ask the 4 carers of children with Prader-willi syndrome to disclose their experiences and difficulties for searching better management and intervention

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle counseling			Other: counseling, emotional support Other: emotional support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
counseling, emotional support	Other		Lifestyle counseling
emotional support

Measure	Description	Time Frame
experience		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a person who care and live with children with Prader-Willi syndrome

Exclusion Criteria:

siblings or less-contact family
teachers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

a person who care and live with childre with Prader-Willi syndrome

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taichung Veterans General Hospital		Taichung		40707	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D011218	Prader-Willi Syndrome

Ancestor Terms

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003376	Counseling

Ancestor Terms

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided