NCT02181036

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 3, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

June 30, 2014

Last Update Submit

July 2, 2014

Conditions

Developmental Delays

Keywords

Family work shopspeech developmental delayschildren

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

family work shopOTHER

2-3 hours per session, one session per week, a total of 6 weeks of family work shop

family work shop

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

Location

Study Officials

  • Ru-Lan Hsieh, MD

    Taipei Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 3, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 3, 2014

Record last verified: 2014-06

Locations

TW(1)