NCT05418933

Brief Summary

To investigate the therapeutic effects of family workshops on children with global developmental delays and their parents by the analysis of the previously conducted workshops.

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
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

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

First Submitted

Initial submission to the registry

June 8, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

June 8, 2022

Last Update Submit

June 12, 2022

Conditions

Keywords

family workshops

Outcome Measures

Primary Outcomes (1)

  • Pediatric Outcome Data Collection Instrument

    measure the functional performance of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome

    scores change of Pediatric Outcome Data Collection Instrument from baseline to 6 weeks after treatment

Secondary Outcomes (9)

  • Mandarin-Chinese Communicative Developmental Inventory

    percent change of Mandarin-Chinese Communicative Developmental Inventory from baseline to 6 weeks after treatment

  • Peabody Developmental Motor Scale

    scores change of Peabody Developmental Motor Scale from baseline to 6 weeks after treatment

  • Emotional Competency Rating Scale

    scores change of Emotional Competency Rating Scale from baseline to 6 weeks after treatment

  • Pediatric Evaluation of Disability Inventory

    scores change of Pediatric Evaluation of Disability Inventory from baseline to 6 weeks after treatment

  • Pediatric Daily Occupation Scale

    scores change Pediatric Daily Occupation Scale from baseline to 6 weeks after treatment

  • +4 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

Family workshops with 5 courses, with 6-7 families in one course, 2 hours per session, one time per week, for a total of 6 weeks.

Other: Family workshop

Interventions

Family workshops for 5 courses, with 6-7 families in one course. The workshops were 2 hours per session, one time per week, for a total of 6 weeks.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Children aged 18-36 months old with global developmental delays (language developmental delay, with motor, cognition, or social and emotional developmental delays) Parents and children attended the one 2 hour-session of workshop per week for 6 weeks

You may not qualify if:

  • Less than 18 months old or older than 36 months old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

Related Publications (1)

  • Hsieh WH, Huang PC, Tsai PC, Lee W, Hu Y, Lee WC, Hsieh RL. Short-term multidisciplinary family-centered workshop for preschool children with global developmental delays. Pediatr Res. 2023 Aug;94(2):707-714. doi: 10.1038/s41390-023-02507-3. Epub 2023 Feb 15.

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hsieh, MD

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsieh, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 14, 2022

Study Start

June 10, 2022

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations