Stuttering, ChildhoodNCT04412213
Correlation of Family History, Age at Onset & Severity of Stuttering
An observational study of Stuttering, Childhood, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Stuttering, Childhood
- What is being tested?
- Stuttering severity instrument for school-age children (SSI-3 Arabic version)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Jul 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 50 stuttering childern, age between 7 and 15 years, with an IQ =80 or more
Who may be able to join
- 1-Age: from 7 to 15 years old. 2-Gender: both sexes will be included in the study. 3-The participants are diagnosed as stutterers by an expert phoniatrician. 4-Children will be accepted only if full information is provided concerning the presence or absence of family history of stuttering, from both paternal and maternal sides of the family, and the age of onset of stuttering manifestations. 5-Mentality: IQ is 80 or more
Who cannot join
- 1-Age below 7 years or above 15 years. 2-Failure to provide full information concerning the presence or absence of family history of stuttering, from both paternal and maternal sides of the family, or age of onset of stuttering manifestations.. 3- IQ less than 80
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation of Family History, Age at Onset and Severity of Stuttering in School-age Children
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.
- Conditions
- Stuttering, Childhood
- Being tested
- Stuttering severity instrument for school-age children (SSI-3 Arabic version)
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stuttering severity instrument for school-age children (SSI-3 Arabic version)Other
Also called Stanford Binet test version 4
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)
| Study group | Role | What they receive |
|---|---|---|
| children of possitive family history of stuttering | Not described Receives: Other: Stuttering severity instrument for school-age children (SSI-3 Arabic version) | |
| children of negative family history of stuttering | Not described Receives: Other: Stuttering severity instrument for school-age children (SSI-3 Arabic version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the correlation between family history, age of onset and severity of stuttering
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.
Measured: year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stuttering, ChildhoodStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherine Khaled Mohammed Elderwy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412213
- Sponsor's protocol ID
- family history of stuttering
- Status last verified
- May 2020
- First submitted
- 29 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 1405533Buck 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.
PubMed 12077503
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Family History, Age at Onset and Severity of Stuttering in School-age Children
- ClinicalTrials.gov ID
- NCT04412213
- Acronym / sponsor ID
- family history of stuttering
- Conditions
- Stuttering, Childhood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 2 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children of possitive family history of stuttering | – | Other: Stuttering severity instrument for school-age children (SSI-3 Arabic version) |
| children of negative family history of stuttering | – | Other: Stuttering severity instrument for school-age children (SSI-3 Arabic version) |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 50 stuttering childern, age between 7 and 15 years, with an IQ =80 or more
Key inclusion criteria (1 listed)
- 1-Age: from 7 to 15 years old. 2-Gender: both sexes will be included in the study. 3-The participants are diagnosed as stutterers by an expert phoniatrician. 4-Children will be accepted only if full information is provided concerning the presence or absence of family history of stuttering, from both paternal and maternal sides of the family, and the age of onset of stuttering manifestations. 5-Mentality: IQ is 80 or more
Key exclusion criteria (1 listed)
- 1-Age below 7 years or above 15 years. 2-Failure to provide full information concerning the presence or absence of family history of stuttering, from both paternal and maternal sides of the family, or age of onset of stuttering manifestations.. 3- IQ less than 80
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 |
|---|---|---|
| Stuttering severity instrument for school-age children (SSI-3 Arabic version)Also: Stanford Binet test version 4Stuttering severity instrument for school-age children (SSI-3 Arabic version) for measuring stuttering severity Stanford Binet test version 4 to evaluate the mentality (IQ) | Other | children of negative family history of stuttering, children of possitive family history of stuttering |
Primary outcome
assess the correlation between family history, age of onset and severity of stuttering
Time frame: year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Background: PubMed 1405533Yairi 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.
- Background: PubMed 12077503Buck 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stuttering, Childhood, run by Assiut University.
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 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Sherine Elderwy (01200148845, sherin.k.elderwy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the correlation between family history, age of onset and severity of stuttering (time frame: year). 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 NCT04412213, which also lists 2 linked publications.
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 2 Jun 2020.