Global Developmental DelayNCT05418933
Workshops for Children With Global Developmental Delays
A study testing Family workshop in people with Global Developmental Delay, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Global Developmental Delay
- What is being tested?
- Family workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jun 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Less than 18 months old or older than 36 months old
Trial locations and contacts
1 site in 1 country.
Hsieh, MD contact
About this study
Official title: 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.
Read the 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:
- Investigate the therapeutic effects of workshops for children with global developmental delays
- Investigate the therapeutic effects of workshops for the parents of children with global developmental delays
- Conditions
- Global Developmental Delay
- Being tested
- Family workshop
- Keywords
- family workshops
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family workshopOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Family workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: scores change of Pediatric Outcome Data Collection Instrument from baseline to 6 weeks after treatment
Secondary outcomes (9)
Mandarin-Chinese Communicative Developmental Inventory
assess communication function of children, <10% indicates delayed development, 10% or more than 10% indicates normal development
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: scores change of Caregiver Strain Index from baseline to 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start10 Jun 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Global Developmental DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention group
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418933
- Sponsor's protocol ID
- SKH-111-1
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36792650
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Family Workshops on Children With Global Developmental Delays and Their Parents
- ClinicalTrials.gov ID
- NCT05418933
- Acronym / sponsor ID
- SKH-111-1
- Conditions
- Global Developmental Delay
- Keywords
- family workshops
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Investigate the therapeutic effects of workshops for children with global developmental delays
- Investigate the therapeutic effects of workshops for the parents of children with global developmental delays
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Family workshopFamily 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. |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Less than 18 months old or older than 36 months old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family workshopFamily 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. | Other | Intervention group |
Primary outcome
Pediatric Outcome Data Collection Instrument
Time frame: scores change of Pediatric Outcome Data Collection Instrument from baseline to 6 weeks after treatment
measure the functional performance of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome
9 secondary outcomes
Mandarin-Chinese Communicative Developmental Inventory
Time frame: percent change of Mandarin-Chinese Communicative Developmental Inventory from baseline to 6 weeks after treatment
Peabody Developmental Motor Scale
Time frame: scores change of Peabody Developmental Motor Scale from baseline to 6 weeks after treatment
Emotional Competency Rating Scale
Time frame: scores change of Emotional Competency Rating Scale from baseline to 6 weeks after treatment
Pediatric Evaluation of Disability Inventory
Time frame: scores change of Pediatric Evaluation of Disability Inventory from baseline to 6 weeks after treatment
Pediatric Daily Occupation Scale
Time frame: scores change Pediatric Daily Occupation Scale from baseline to 6 weeks after treatment
Pediatric Quality of Life Inventory-Geriatric Core Scale
Time frame: 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
Time frame: scores change of Pediatric Quality of Life Inventory-Family Impact Module from baseline to 6 weeks after treatment
Parental satisfaction questionnaire
Time frame: scores of Parental satisfaction questionnaire after treatment
Caregiver Strain Index
Time frame: scores change of Caregiver Strain Index from baseline to 6 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Derived from this study: PubMed 36792650Hsieh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsieh, MD contact
Hsieh, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family workshop in people with Global Developmental Delay, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru-Lan Hsieh, MD (886-2-28332211 ext. 2531, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Outcome Data Collection Instrument (time frame: scores change of Pediatric Outcome Data Collection Instrument from baseline to 6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05418933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.