NCT02523963

Brief Summary

The purpose of this study is to identify the effects of family work shop for children with 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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_4

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

August 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

August 7, 2015

Last Update Submit

August 13, 2015

Conditions

Developmental Delays

Keywords

family work shop

Outcome Measures

Primary Outcomes (1)

  • change in health related quality of life questionnaire

    to identify the changes of health related quality of life of children after the workshop

    baseline and 6 weeks

Study Arms (2)

study group

EXPERIMENTAL

children with developmental delays participated 6 sessions of family work shop 1. The family work shop has 5 courses, with 6 families in one course. 2. Intervention of one course: 2-3 hours per session, one time per week, for a total of 6 weeks.

Other: family work shop

control

NO INTERVENTION

children with normal development not participate the work shop followed up at before, and 6 weeks later

Interventions

family work shopOTHER

1. The family work shop has 5 courses, with 6 families in one course. 2. One course of intervention: 2-3 hours per session, one time per week, for a total of 6 sessions in 6 week periods

study group

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of developmental delays and must be able to attend 6 weeks of work shop

You may not qualify if:

  • Failed to obtain written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

Study Officials

  • Ru-Lan Hsieh, MD

    visiting staff of Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan h, MD

CONTACT

886-2-28332211M001052@ms.skh.org.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 7, 2015

First Posted

August 14, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

August 14, 2015

Record last verified: 2015-08

Locations

TW(1)