Workshops for Children With Global Developmental Delays

Effects of Family Workshops on Children With Global Developmental Delays and Their Parents

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Global Developmental Delay
• Intervention / Treatment: Other: Family workshop

Detailed Description

To evaluate the effects of family workshops for children aged 18-36 months old with language developmental delays conducted from Jan 2014 Jan to Dec 2018, by the data analysis.

The participants were children with global developmental delay (language delay with at least one delay in motor, cognitive function, or emotional and social functioning) and their parents in the workshops.

The family workshops were conducted with 5 courses, with 6-7 families in one course, a 2-hour session per week, for 6 weeks.

Effects:

1. Investigate the therapeutic effects of workshops for children with global developmental delays
2. Investigate the therapeutic effects of workshops for the parents of children with global developmental delays

• Study Type: Interventional
• Enrollment (Anticipated): 101
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsieh, MD

Study Locations

• Taiwan
  • Taipei, Taiwan, 111-01
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mandarin-Chinese Communicative Developmental Inventory	assess communication function of children, <10% indicates delayed development, 10% or more than 10% indicates normal development	percent change of Mandarin-Chinese Communicative Developmental Inventory from baseline to 6 weeks after treatment
Peabody Developmental Motor Scale	assess fine motor function of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change of Peabody Developmental Motor Scale from baseline to 6 weeks after treatment
Emotional Competency Rating Scale	assess the emotional function of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change of Emotional Competency Rating Scale from baseline to 6 weeks after treatment
Pediatric Evaluation of Disability Inventory	assess the functional skill attainment of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change of Pediatric Evaluation of Disability Inventory from baseline to 6 weeks after treatment
Pediatric Daily Occupation Scale	assess the occupational performance in the daily life of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change Pediatric Daily Occupation Scale from baseline to 6 weeks after treatment
Pediatric Quality of Life Inventory-Geriatric Core Scale	assess the quality of life of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change ofPediatric Quality of Life Inventory-Geriatric Core Scale from baseline to 6 weeks after treatment
Pediatric Quality of Life Inventory-Family Impact Module	assess the impact of pediatric conditions on family functioning and parental quality of life, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome	scores change of Pediatric Quality of Life Inventory-Family Impact Module from baseline to 6 weeks after treatment
Parental satisfaction questionnaire	assess the parents' satisfaction with the workshops, with scores ranging from 1-to 100, higher scores mean a higher satisfaction	scores of Parental satisfaction questionnaire after treatment
Caregiver Strain Index	assess family strain, the minimum and maximum values range from 1 to 100, higher scores mean a worse outcome	scores change of Caregiver Strain Index from baseline to 6 weeks after treatment

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 10, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: family workshops
• Other Study ID Numbers: SKH-111-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No