NCT03209453

Brief Summary

To identify the therapeutic effects of short-term family-centered 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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

July 4, 2017

Last Update Submit

July 4, 2017

Conditions

Keywords

family work shop

Outcome Measures

Primary Outcomes (1)

  • change from baseline functional performance (scores) at 6 weeks

    Pediatric Outcome Data Collection Instrument

    baseline and up to 6 weeks

Secondary Outcomes (4)

  • change from baseline health-related quality of life (scores) at 6 weeks

    baseline and up to 6 weeks

  • change from baseline caregiver health-related quality of life (scores) at 6 weeks

    baseline and up to 6 weeks

  • change from baseline family strain (scores) at 6 weeks

    baseline and up to 6 weeks

  • change from baseline family impact

    baseline and up to 6 weeks

Study Arms (2)

study group

EXPERIMENTAL

children with developmental delays, under regular rehabilitation programs, participate the family work shop family work shop: 6 families in one course, 2 hours per session, one session per week, a total of 6 weeks

Other: family work shop

control group

NO INTERVENTION

children with developmental delays, under regular rehabilitation programs, not participate the family work shop

Interventions

Children with developmental delays, under regular rehabilitation programs, participate 6 sessions of family work shop The family work shop had 6 families in one course, 2 hours per week, for a total of 6 weeks.

study group

Eligibility Criteria

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

You may qualify if:

  • M/O to 36 M/O children with developmental delays, under regular rehabilitation programs

You may not qualify if:

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

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 6, 2017

Study Start

July 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 6, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations