<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/NCT04412213</url>
  </required_header>
  <id_info>
    <org_study_id>family history of stuttering</org_study_id>
    <nct_id>NCT04412213</nct_id>
  </id_info>
  <brief_title>Correlation of Family History, Age at Onset &amp; Severity of Stuttering</brief_title>
  <official_title>Correlation of Family History, Age at Onset and Severity of Stuttering in School-age Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to Detect the influence of the family history of stuttering&#xD;
      (distance of relative) on the onset and severity of stuttering in children in these families.&#xD;
      Also to explore developmental differences among young stutterers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>assess the correlation between family history, age of onset and severity of stuttering</measure>
    <time_frame>year</time_frame>
    <description>family history may affect the onset of stuttering and its severity. children with possitive family history of stuttering may develope stuttering earlier than children with negative family history and stuttering could be more severe in the first group.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Stuttering, Childhood</condition>
  <arm_group>
    <arm_group_label>children of possitive family history of stuttering</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>children of negative family history of stuttering</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stuttering severity instrument for school-age children (SSI-3 Arabic version)</intervention_name>
    <description>Stuttering severity instrument for school-age children (SSI-3 Arabic version) for measuring stuttering severity Stanford Binet test version 4 to evaluate the mentality (IQ)</description>
    <arm_group_label>children of negative family history of stuttering</arm_group_label>
    <arm_group_label>children of possitive family history of stuttering</arm_group_label>
    <other_name>Stanford Binet test version 4</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        50 stuttering childern, age between 7 and 15 years, with an IQ =80 or more&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1-Age: from 7 to 15 years old. 2-Gender: both sexes will be included in the study.&#xD;
             3-The participants are diagnosed as stutterers by an expert phoniatrician. 4-Children&#xD;
             will be accepted only if full information is provided concerning the presence or&#xD;
             absence of family history of stuttering, from both paternal and maternal sides of the&#xD;
             family, and the age of onset of stuttering manifestations. 5-Mentality: IQ is 80 or&#xD;
             more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1-Age below 7 years or above 15 years. 2-Failure to provide full information&#xD;
             concerning the presence or absence of family history of stuttering, from both paternal&#xD;
             and maternal sides of the family, or age of onset of stuttering manifestations.. 3- IQ&#xD;
             less than 80&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sherine Elderwy</last_name>
    <phone>01200148845</phone>
    <email>sherin.k.elderwy@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Yairi E, Ambrose N. Onset of stuttering in preschool children: selected factors. J Speech Hear Res. 1992 Aug;35(4):782-8. doi: 10.1044/jshr.3504.782.</citation>
    <PMID>1405533</PMID>
  </reference>
  <reference>
    <citation>Buck SM, Lees R, Cook F. The influence of family history of stuttering on the onset of stuttering in young children. Folia Phoniatr Logop. 2002 May-Jun;54(3):117-24. doi: 10.1159/000063407.</citation>
    <PMID>12077503</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sherine Khaled Mohammed Elderwy</investigator_full_name>
    <investigator_title>Resident of Phoniatrics at Assiut Psychiatric Health Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stuttering</mesh_term>
  </condition_browse>
  <!-- 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/NCT04412213
org study id: family history of stuttering
nct id: NCT04412213
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to Detect the influence of the family history of stuttering
      (distance of relative) on the onset and severity of stuttering in children in these families.
      Also to explore developmental differences among young stutterers.
observational model: Cohort
time perspective: Cross-Sectional
measure: assess the correlation between family history, age of onset and severity of stuttering
time frame: year
description: family history may affect the onset of stuttering and its severity. children with possitive family history of stuttering may develope stuttering earlier than children with negative family history and stuttering could be more severe in the first group.
arm group label: children of possitive family history of stuttering
arm group label: children of negative family history of stuttering
intervention type: Other
intervention name: Stuttering severity instrument for school-age children (SSI-3 Arabic version)
description: Stuttering severity instrument for school-age children (SSI-3 Arabic version) for measuring stuttering severity Stanford Binet test version 4 to evaluate the mentality (IQ)
arm group label: children of negative family history of stuttering
arm group label: children of possitive family history of stuttering
other name: Stanford Binet test version 4
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sherine Elderwy
phone: 01200148845
email: sherin.k.elderwy@gmail.com
citation: Yairi E, Ambrose N. Onset of stuttering in preschool children: selected factors. J Speech Hear Res. 1992 Aug;35(4):782-8. doi: 10.1044/jshr.3504.782.
PMID: 1405533
citation: Buck SM, Lees R, Cook F. The influence of family history of stuttering on the onset of stuttering in young children. Folia Phoniatr Logop. 2002 May-Jun;54(3):117-24. doi: 10.1159/000063407.
PMID: 12077503
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sherine Khaled Mohammed Elderwy
investigator title: Resident of Phoniatrics at Assiut Psychiatric Health Hospital
mesh term: Stuttering