Effects of Work Shop for Children With Developmental Delays | NCT02181036

Studies
Effects of Work Shop for Children With Developmental Delays

NCT02181036

Sponsor

Taipei Medical University

Status

Unknown status

Last Update Posted

Jul 3, 2014Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Developmental Delays

Interventions

family work shop

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

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

Jun 30, 2014

First Submission Date that Met QC Criteria

Jul 2, 2014

First Posted Date

Jul 3, 2014Estimated

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

Jul 2, 2014

Last Update Posted Date

Jul 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

To identify the effects of family work shop for children with speech developmental delays.

Detailed Description

To assess the improvement of functional performance of children with speech developmental delays by 2-3 hours per session, one session per week, a total of 6 weeks of family work shop

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
family work shop	Experimental	2 to 3 hours per session, one session per week, for a total of 6 weeks of family work shop	Other: family work shop

Interventions

Name	Type	Description	Arm Group Labels	Other Names
family work shop	Other	2-3 hours per session, one session per week, a total of 6 weeks of family work shop	family work shop

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes of pediatric health related quality of life (Pediatric Quality of Life Inventory)	participants receive one 2-hour session of work shop per week for a 6-week duration	participants will be evaluated at before and after 6 weeks of work shop

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 M/O to 36 M/O of children with speech development delay

Exclusion Criteria:

less than 18 M/O older than 36 M/O

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

36 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ru-Lan Hsieh, MD	Taipei Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shin Kong Wu Ho-Su Memorial Hospital		Taipei		111	Taiwan