<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04413630</url>
  </required_header>
  <id_info>
    <org_study_id>SKH-109</org_study_id>
    <nct_id>NCT04413630</nct_id>
  </id_info>
  <brief_title>Workshops for Toddlers With Speech and Language Developmental Delay</brief_title>
  <official_title>Therapeutic Effects of Family-centered Workshops for Toddlers With Speech and Language Developmental Delay</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify the therapeutic effects of family workshops on&#xD;
      speech and language developmentally delayed children and their family&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The family workshop with 5 courses, 6 families in one course, a 2-hour session per week, for&#xD;
      6 weeks.&#xD;
&#xD;
      Effects:&#xD;
&#xD;
        1. Investigate the therapeutic effects of the workshop for the toddlers with developmental&#xD;
           delay&#xD;
&#xD;
        2. Investigate the therapeutic effects of the workshop for the parents of toddlers with&#xD;
           developmental delay&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Intervention group</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chinese Communicative Developmental Inventory</measure>
    <time_frame>scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome</time_frame>
    <description>assess communication and language function of children</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peabody Developmental Motor Scales</measure>
    <time_frame>scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome</time_frame>
    <description>assess fine motor function of children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Outcomes Data Collection Instrument</measure>
    <time_frame>scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome</time_frame>
    <description>measure the functional performance of children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Health Questionnaire-Parent Form 28</measure>
    <time_frame>scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome</time_frame>
    <description>assess the health status of children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Quality of Life Inventory-Geriatric Core Scales</measure>
    <time_frame>scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome</time_frame>
    <description>measure the quality of life of children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Strain Index</measure>
    <time_frame>scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome</time_frame>
    <description>assess family strain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on Family Scale</measure>
    <time_frame>scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome</time_frame>
    <description>assess the effects of a child's illness of the function of the family system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Quality of Life Inventory-Family Impact Module</measure>
    <time_frame>scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome</time_frame>
    <description>assess the impact of pediatric conditions on family function and quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality of Life Brief Version</measure>
    <time_frame>scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome</time_frame>
    <description>evaluate parents' quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental satisfaction questionnaire</measure>
    <time_frame>after completion of 6 weeks of workshop</time_frame>
    <description>assess the parents' subjective satisfaction to the whole workshop itself, score ranges from 0 to 100, higher scores mean a higher satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Competency Rating Scales</measure>
    <time_frame>scores change from baseline to 6 weeks after treatment</time_frame>
    <description>assess emotional function of children, higher scores mean a better outcome</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Developmental Delay</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>family workshop</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>family workshop</intervention_name>
    <description>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</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 36 months old children with speech and language developmental delay with or&#xD;
             without delay in gross motor, fine motor, cognition, and emotional or social function&#xD;
&#xD;
        the availability of toddlers and their parents to attend one 2-hour session of the workshop&#xD;
        per week for 6 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 months old or older than 36 months old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ru-Lan Hsieh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shin Kong Wu Ho-Su Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shin Kong Wu Ho-Su Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>111-01</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>family workshop</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04413630
org study id: SKH-109
nct id: NCT04413630
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to identify the therapeutic effects of family workshops on
      speech and language developmentally delayed children and their family
The family workshop with 5 courses, 6 families in one course, a 2-hour session per week, for
      6 weeks.

      Effects:

        1. Investigate the therapeutic effects of the workshop for the toddlers with developmental
           delay

        2. Investigate the therapeutic effects of the workshop for the parents of toddlers with
           developmental delay
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Intervention group
primary purpose: Health Services Research
masking: None (Open Label)
measure: Chinese Communicative Developmental Inventory
time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
description: assess communication and language function of children
measure: Peabody Developmental Motor Scales
time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
description: assess fine motor function of children
measure: Pediatric Outcomes Data Collection Instrument
time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
description: measure the functional performance of children
measure: Child Health Questionnaire-Parent Form 28
time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a better outcome
description: assess the health status of children
measure: 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
description: measure the quality of life of children
measure: Caregiver Strain Index
time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
description: assess family strain
measure: Impact on Family Scale
time frame: scores change from baseline to 6 weeks after treatment, higher scores mean a worse outcome
description: assess the effects of a child's illness of the function of the family system
measure: 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
description: assess the impact of pediatric conditions on family function and quality of life
measure: 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
description: evaluate parents' quality of life
measure: Parental satisfaction questionnaire
time frame: after completion of 6 weeks of workshop
description: assess the parents' subjective satisfaction to the whole workshop itself, score ranges from 0 to 100, higher scores mean a higher satisfaction
measure: Emotional Competency Rating Scales
time frame: scores change from baseline to 6 weeks after treatment
description: assess emotional function of children, higher scores mean a better outcome
arm group label: Study group
arm group type: Experimental
description: family workshop
intervention type: Other
intervention name: family workshop
description: 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
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Months
maximum age: 36 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Ru-Lan Hsieh, MD
role: Principal Investigator
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
sharing ipd: No