Stuttering, ChildhoodNCT05640440
Executive Function Performance in Children Who Stutter
An observational study of Stuttering, Childhood and Executive Dysfunction, run by Sohag University at 1 site in Egypt.
Trial summary
The study aims to asses the executive function in children who stutter for better management of those children 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, Executive Dysfunction
- What is being tested?
- Executive function testing
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Jul 2024
- 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: 30 case group, 15 control group age range 7 yrs old and 15 yrs old
Who may be able to join
- Patient and volunteers age between 7 years and 15 years.
- IQ ≥ 85.
Who cannot join
- History of secondary stuttering.
- Language impairment and other speech problem.
- Concurrent or history of psychiatric, cognitive, neurological disorders or hearing impairment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Rasha Mohamed Hashem
Sohag, 82511
Rasha M Hashem, assistant lectural, 01061966022 ext. 002, rasha.hashem@med.sohag.edu.eg
Ahlam A Nabieh, professor, 01029945463 ext. 02, ahlamaa@yahoo.com
About this study
The study aims to asses the executive function in children who stutter for better management of those children
Read the detailed description
It is a case control study which will be done on 30 child who stutter and 15 normal child as a control group. Executive function testing will be done using computerized program called PEPL . Also, total intelligence quation(IQ) , verbal IQ, non verbal IQ will be assessed in both groups. stuttering severity will be assessed in case group.
- Conditions
- Stuttering, Childhood, Executive Dysfunction
- Being tested
- Executive function testing
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive function testingDiagnostic test
Assessment of executive function subdivision
| Study group | Role | What they receive |
|---|---|---|
| children who stutter | assessment executive function and stuttering severity in 30 child with stuttering Receives: Diagnostic Test: Executive function testing | |
| children who don't stutter | assessment executive function in 30 child with stuttering Receives: Diagnostic Test: Executive function testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEPL numerical stroop test
Using the Psychological Experimental Building Language (PEBL) current version 2.1 released at 2018 (Muller \& Piper, 2014). The test measuring inhibitory function It asses the reaction time in seconds, the total numbers of errors ranging between 0-200
Measured: one year
Cognitive flexibility function (sub-division of executive function testing)
PEPL Berg's Card Sorting Test 64 version of Berg's (1948) Wisconsin Card Sorting Test. The child is asked to sort multi-attribute cards into piles according to an unknown and changing rule. It provides an indication of which rule (shape, color or number) is easiest for the individual. It aims to asses Number of Correct Responses: ranging between 0-64 Number of Total Errors ranging between 0-64 Percent of Perseverative Responses Percent of Perseverative Errors Percent of Non-Perseverative Errors Number of Unique Errors
Measured: one year
Working memory score
Sub-test of Stanford-Binet Intelligence Scales, 5th Edition (SB5) The score ranging between 40-130
Measured: one year
Secondary outcomes (2)
Non word Repetation score(Fawzy et al., 2012)
To test the working memory abilities. the child is asked to repeat a number of non sense words. The score ranges between 0 to 30
Measured: one year
Backward digit span score (Aboras et al., 2008)
It test the working memory. The child is asked to retell a number of digit in backward manner. The score ranges between 0 to 14.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stuttering, ChildhoodStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Mohamed Hashem, Sohag University
- Investigators
- Ahlam A Nabieh, professor, Study director, ahlaama@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640440
- Sponsor's protocol ID
- Soh-med-22-11-11
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Function Performance in Children Who Stutter
- ClinicalTrials.gov ID
- NCT05640440
- Acronym / sponsor ID
- Soh-med-22-11-11
- Conditions
- Stuttering, Childhood, Executive Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 7 Dec 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.
The study aims to asses the executive function in children who stutter for better management of those children
Detailed description
It is a case control study which will be done on 30 child who stutter and 15 normal child as a control group. Executive function testing will be done using computerized program called PEPL . Also, total intelligence quation(IQ) , verbal IQ, non verbal IQ will be assessed in both groups. stuttering severity will be assessed in case group.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children who stutter | – | Diagnostic Test: Executive function testingassessment executive function and stuttering severity in 30 child with stuttering |
| children who don't stutter | – | Diagnostic Test: Executive function testingassessment executive function in 30 child with stuttering |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 30 case group, 15 control group age range 7 yrs old and 15 yrs old
Key inclusion criteria (2 listed)
- Patient and volunteers age between 7 years and 15 years.
- IQ ≥ 85.
Key exclusion criteria (3 listed)
- History of secondary stuttering.
- Language impairment and other speech problem.
- Concurrent or history of psychiatric, cognitive, neurological disorders or hearing impairment.
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 |
|---|---|---|
| Executive function testingAssessment of executive function subdivision | Diagnostic test | children who don't stutter, children who stutter |
Primary outcome
PEPL numerical stroop test
Time frame: one year
Using the Psychological Experimental Building Language (PEBL) current version 2.1 released at 2018 (Muller \& Piper, 2014). The test measuring inhibitory function It asses the reaction time in seconds, the total numbers of errors ranging between 0-200
Cognitive flexibility function (sub-division of executive function testing)
Time frame: one year
PEPL Berg's Card Sorting Test 64 version of Berg's (1948) Wisconsin Card Sorting Test. The child is asked to sort multi-attribute cards into piles according to an unknown and changing rule. It provides an indication of which rule (shape, color or number) is easiest for the individual. It aims to asses Number of Correct Responses: ranging between 0-64 Number of Total Errors ranging between 0-64 Percent of Perseverative Responses Percent of Perseverative Errors Percent of Non-Perseverative Errors Number of Unique Errors
Working memory score
Time frame: one year
Sub-test of Stanford-Binet Intelligence Scales, 5th Edition (SB5) The score ranging between 40-130
2 secondary outcomes
Non word Repetation score(Fawzy et al., 2012)
Time frame: one year
Backward digit span score (Aboras et al., 2008)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ahlam A Nabieh, professor study director
ahlaama@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stuttering, Childhood and Executive Dysfunction, run by Sohag University at 1 site in Egypt.
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 3 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 7 Dec 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 Egypt. 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 Rasha Mo Hashem, Assistant lecture (01061966022 ext. 002, rasha.hashem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PEPL numerical stroop test (time frame: one year). The study lists 3 primary outcomes in all. 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 7 Dec 2022.