Developmental DelayNCT04413630
Workshops for Toddlers With Speech and Language Developmental Delay
A study testing family workshop in people with Developmental Delay, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study is to identify the therapeutic effects of family workshops on speech and language developmentally delayed children and their family Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay
- What is being tested?
- family workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2014to 31 Dec 2018
- 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
- 18 to 36 months old children with speech and language developmental delay with or without delay in gross motor, fine motor, cognition, and emotional or social function
- the availability of toddlers and their parents to attend one 2-hour session of the 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.
About this study
Official title: Therapeutic Effects of Family-centered Workshops for Toddlers With Speech and Language Developmental Delay
The purpose of this study is to identify the therapeutic effects of family workshops on speech and language developmentally delayed children and their family
Read the detailed description
The family workshop with 5 courses, 6 families in one course, a 2-hour session per week, for 6 weeks.
Effects:
- Investigate the therapeutic effects of the workshop for the toddlers with developmental delay
- Investigate the therapeutic effects of the workshop for the parents of toddlers with developmental delay
- Conditions
- Developmental Delay
- Being tested
- family workshop
- Keywords
- family workshop
- 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
The family workshop with 5 courses, with 6 families in one course The intervention of one course; 2 hours per session, one time per week, for a total of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | family workshop Receives: Other: family workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese Communicative Developmental Inventory
assess communication and language function of children
Measured: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Secondary outcomes (10)
Peabody Developmental Motor Scales
assess fine motor function of children
Measured: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Pediatric Outcomes Data Collection Instrument
measure the functional performance of children
Measured: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Child Health Questionnaire-Parent Form 28
assess the health status of children
Measured: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Pediatric Quality of Life Inventory-Geriatric Core Scales
measure the quality of life of children
Measured: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Caregiver Strain Index
assess family strain
Measured: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
Impact on Family Scale
assess the effects of a child's illness of the function of the family system
Measured: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
Pediatric Quality of Life Inventory-Family Impact Module
assess the impact of pediatric conditions on family function and quality of life
Measured: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
World Health Organization Quality of Life Brief Version
evaluate parents' quality of life
Measured: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Parental satisfaction questionnaire
assess the parents' subjective satisfaction to the whole workshop itself, score ranges from 0 to 100, higher scores mean a higher satisfaction
Measured: after completion of 6 weeks of workshop
Emotional Competency Rating Scales
assess emotional function of children, higher scores mean a better outcome
Measured: scores change 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 posted4 Jun 2020
- Study start1 Jan 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413630
- Sponsor's protocol ID
- SKH-109
- Status last verified
- May 2020
- First submitted
- 29 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Family-centered Workshops for Toddlers With Speech and Language Developmental Delay
- ClinicalTrials.gov ID
- NCT04413630
- Acronym / sponsor ID
- SKH-109
- Conditions
- Developmental Delay
- Keywords
- family workshop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Jun 2020 (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.
The purpose of this study is to identify the therapeutic effects of family workshops on speech and language developmentally delayed children and their family
Detailed description
The family workshop with 5 courses, 6 families in one course, a 2-hour session per week, for 6 weeks.
Effects:
- Investigate the therapeutic effects of the workshop for the toddlers with developmental delay
- Investigate the therapeutic effects of the workshop for the parents of toddlers with developmental delay
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention group
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: family workshopfamily workshop |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 18 to 36 months old children with speech and language developmental delay with or without delay in gross motor, fine motor, cognition, and emotional or social function
- the availability of toddlers and their parents to attend one 2-hour session of the 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 workshopThe family workshop with 5 courses, with 6 families in one course The intervention of one course; 2 hours per session, one time per week, for a total of 6 weeks | Other | Study group |
Primary outcome
Chinese Communicative Developmental Inventory
Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
assess communication and language function of children
10 secondary outcomes
Peabody Developmental Motor Scales
Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Pediatric Outcomes Data Collection Instrument
Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Child Health Questionnaire-Parent Form 28
Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Pediatric Quality of Life Inventory-Geriatric Core Scales
Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Caregiver Strain Index
Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
Impact on Family Scale
Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
Pediatric Quality of Life Inventory-Family Impact Module
Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
World Health Organization Quality of Life Brief Version
Time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
Parental satisfaction questionnaire
Time frame: after completion of 6 weeks of workshop
Emotional Competency Rating Scales
Time frame: scores change from baseline to 6 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- 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.
Ru-Lan 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 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 2 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: finished, as of the sponsor's last update on 4 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese Communicative Developmental Inventory (time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2020.