Study emotion perception and the effect of the combined program of Camperdown and emotional intelligence training on the improvement of speech fluency and emotion perception in adults with stuttering
Determining the emotion perception and the effect of the combined program of Camperdown and emotional intelligence training on the improvement of speech fluency and emotion perception in adults with stuttering
Design
The clinical trial has two intervention and control groups, with parallel, randomized, phase 2 groups on 30 people, . random assignment sampling method based on entry and exit criteria and matching according to gender and severity of stuttering are placed in one of the treatment groups "combination of Camperdown with emotional intelligence training" and "Camperdown".
Settings and conduct
The study is conducted in speech therapy clinics affiliated with the Faculty of Rehabilitation Sciences and other speech therapy clinics in Tehran. In the intervention group, we have a treatment program based on changing the speech structure. In addition to the speech therapy program, the control group also receives emotional intelligence training.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adults with stuttering, Age range from 18 to 40 years, developmental stuttering, at least 10% stuttered syllables, Persian language and monolingual and minimum education level of diploma, normal hearing and vision range or correction no depression and no use of depression drugs, no problems related to the nervous system affecting speech and no treatment for the past 2 years and no history of drug treatment to treat stuttering and prove the problem of emotion perception with the help of the test of PAV.
Intervention groups
We have two treatment groups, one treatment group receives the "Camperdown"and the other group as a control group receives "combinaction of Camperdown with emotional intelligence training"
Main outcome variables
Emotion perception؛ Severity of stuttering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240322061348N1
Registration date:2024-07-13, 1403/04/23
Registration timing:retrospective
Last update:2024-07-13, 1403/04/23
Update count:0
Registration date
2024-07-13, 1403/04/23
Registrant information
Name
Masoome Basi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
basie.masume@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study emotion perception and the effect of the combined program of Camperdown and emotional intelligence training on the improvement of speech fluency and emotion perception in adults with stuttering
Public title
Study emotion perception and the effect of the combined program of Camperdown and emotional intelligence training on the improvement of speech fluency and emotion perception in adults with stuttering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Occurrence of developmental stuttering before the age of 12
Presence of at least 10% stuttered syllables
Farsi-speaking and monolingual people.
Have a minimum education level of diploma.
Normality of the range of hearing and vision or corrected.
Not suffering from depression and not using depression drugs by asking the patient.
Absence of stroke and other diseases of the nervous system affecting the speech system.
Not receiving treatments based on changing the speech structure from the last 2 years until now.
No history of drug treatment for stuttering
Exclusion criteria:
Candidate withdrawal in any of the evaluation stages for any reason
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In the first phase, based on the entry and exit criteria, adults with stuttering are selected from among those who refer to the rehabilitation and hospital centers of Iran University of Medical Sciences who have stuttering according to the diagnosis and approval of the researcher, and healthy adults (in terms of speech) are also selected in terms of age and gender with Stuttering groups are matched. In the second phase, among the people with stuttering who have difficulty in understanding emotions, with random allocation sampling method based on entry and exit criteria and matching according to gender and severity of stuttering, they were placed in one of the treatment groups "combination of Comperdown with emotional intelligence training" and "Comperdown". they take
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committees of Iran university of Medical Sciences
Street address
Faculty of Rehabilitation Sciences., Department of Speech Therapy., Shah Nazari Street., Madadkaran Street., Mader Square., Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.IUMS.REC.1402.1028
Health conditions studied
1
Description of health condition studied
Adults with stuttering
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Estimation of the average score of emotion Perception
Timepoint
2 weeks
Method of measurement
The emotion perception test is conducted with the help of the non-verbal emotional fragments (MAV) test, which includes understanding the emotions of happiness, sadness, fear, anger, hatred, and neutral expressed by professional actors. The participants must identify the emotion they hear among the above emotions. Stimuli are presented in random order to control the effects of fatigue and order. Stimuli are presented to participants in comfortable conditions and through headphones. During the evaluation, people will be given a break if they request. Of course, in this research, the Persianlized version of this test, which was prepared by Saffarian in 2017, is used.
2
Description
The percentage of stuttered syllables
Timepoint
2 weeks
Method of measurement
The number of stuttered syllables divided by the total number of spoken syllables
3
Description
A comprehensive assessment of the individual's experience of stuttering
Timepoint
2 weeks
Method of measurement
This test consists of 100 questions, each of which is scored based on a Likert scale ranging from 1 to 5. This instrument, which is completed by the stutterer himself, is organized into 4 sections: a) general information b) reactions to stuttering c) communication in everyday situations and d) quality of life. The general information section is related to a person's interpretation of the fluency and naturalness of speech, his knowledge about stuttering and its treatment, and overall attitude towards stuttering. The results of this questionnaire are reported in the form of 2 scales of the amount and intensity of the effect.
Secondary outcomes
1
Description
Emotional Intelligence
Timepoint
2 weeks
Method of measurement
The Persian version of the emotional intelligence questionnaire of Shatt & etal
Intervention groups
1
Description
"intervention group:" This program consists of four stages, which include: 1. Teaching treatment components, 2. Creating speech without stuttering in a natural way together with the therapist, 3. generalization and 4. Keep the result. In this research, we implement the first three stages of the treatment program based on the effectiveness of previous studies. The time required to complete the first three stages of this treatment program is 10-20 hours on average. This treatment program is performed in 15 sessions, each session lasting 45 minutes.
Category
Rehabilitation
2
Description
"control group:"Emotional intelligence training Emotional intelligence from the "control group: Camperdown's combination with emotional intelligence training.emotional intelligence training includes a two-and-a-half-day (15 hours) group therapy program that trains emotional-emotional capacities. Two days and one (12 hours) include intensive organized training that is about the acquisition or improvement of 4 important emotional-emotional capacities. 1) Identifying one's own and others' feelings. 2) Understanding emotions (predictions and their consequences). 3) Regulation of own and others' feelings. 4) Effective use of emotions and feelings to strengthen their thinking and actions. At the end of each day, a series of texts and reminders are given to people. 2 weeks after the start of the treatment, a half-day (3-hour) reminder session is held to encourage people to try to apply the training.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation and Hospital centers of Iran University of Medical Sciences
Full name of responsible person
Masoomeh Basi
Street address
Faculty of Rehabilitation Sciences, Department of Speech Therapy, Shah Nazari Street, Madderan Street, Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 8051
Email
basie.masume@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Afsun Hosni Mehraban
Street address
Faculty of Rehabilitation Sciences., Shah Nazari Street., Madadkaran Street., Mader Square., Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21 2222 8051
Email
Basie.masume@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Basi
Position
Candidate of phd of speech therapy
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Faculty of Rehabilitation Sciences., Department of Speech Therapy., Shah Nazari Street., Madadkaran Street., Mader Square., Mirdamad Blvd.,
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
22228051-2 - ۲۲۲۲۷۱۲۴- ۲۲۲۲۲۰۵۹ - 26405626
Email
basie.masume@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Basi
Position
PHD candidate of speech therpy
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Faculty of Rehabilitation Sciences., Department of Speech Therapy., Shah Nazari Street., Madadkaran Street., Mader Square., Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
0098 21 22228051-2
Email
basie.masume@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Basi
Position
Candidate of PHD Speech Therapy
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy., Faculty of Rehabilitation Sciences., Shah Nazari Street., Madadkaran Street., Mader Square., Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
Basie.masume@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the information obtained in each of the phases, including information on understanding emotions, stuttering severity, individual's experience of stuttering and emotional intelligence from each client of the treatment intervention group and the control group can be obtained.
When the data will become available and for how long
3 month
To whom data/document is available
Researcher, Supervisor, Research committee
Under which criteria data/document could be used
If this information contains clinical information
From where data/document is obtainable
All the information obtained by the researcher will be made available to the supervisors and the research committee. This information is available in the Faculty of Rehabilitation in the speech therapy department.
What processes are involved for a request to access data/document
After requesting information from the research committee and supervisors, the researcher provides them with all the information of the research steps in a file stored in a maximum period of two months.