Determining the effectiveness of risperidone in the treatment of developmental stuttering in children aged 5 to 10 years
Design
A controlled, double-blind, randomized, phase 3 clinical trial on 30 patients. Permutation block method was used for randomization.
Settings and conduct
Rospective quasi-experimental study will be conducted in 2024 to investigate the efficacy of a specific speech therapy intervention for stuttering in children aged 5-10 years. Baseline stuttering severity will be assessed using the SSI-3, and ADHD symptoms will be evaluated with the Conners' scale. Participants will self-rate their stuttering daily and receive standardized speech therapy. Stuttering severity, adverse effects, and treatment adherence will be measured at weeks 4 and 10.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. The age range of 5 to 10 years,
2. Having a diagnosis of developmental stuttering disorder based on the mentioned criteria
3. Absence of any language, speech or reading disorders other than stuttering
4. Absence of any kind of neurological, movement, vision, hearing, mental-cognitive problem
5. Not taking drugs affecting cognitive function or stuttering in the last month
6. No history of speech therapy treatment in the last 3 months
Exclusion criteria:
The patient's unwillingness to cooperate in the research
Intervention groups
One group received risperidone and speech therapy, and the other group received placebo and speech therapy
Main outcome variables
1- Severity of stuttering
2- Duration of recovery of stuttering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240527061909N1
Registration date:2024-07-29, 1403/05/08
Registration timing:prospective
Last update:2024-07-29, 1403/05/08
Update count:0
Registration date
2024-07-29, 1403/05/08
Registrant information
Name
Armon Masoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
armonmassoodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the efficacy of Risperidone in the treatment of developmental stuttering in Persian-speaking children aged 5 to 10 years
Public title
Investigation of the efficacy of Risperidone in the treatment of developmental stuttering in Persian-speaking children aged 5 to 10 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age range from 5 to 10 years
2. Having a diagnosis of developmental stuttering disorder based on the score of the SSI-3 test and the therapist's speech diagnosis
3. Absence of any language, speech or reading disorders other than stuttering
4. Absence of any kind of neurological, movement, vision, hearing, mental-cognitive problems in the past or present
5. Not taking drugs affecting cognitive function or stuttering, in the last month or during research
6. Absence of history of speech therapy treatment at least in the last 3 months
Exclusion criteria:
The individual's unwillingness to cooperate in any stage of the research.
Age
From 5 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the allocation of participants to each group and concealment of the treatment process will be done using the permutation block method. The size of the blocks is 4, the ratio of speech therapy + drug and speech therapy + placebo is considered 1:1 in each block. The randomization sequence will be done using the seadenvelop.com website and by the design methodologist.
In order to hide the treatment process, a random code is assigned to each of the two groups in the generated sequence list. When each person enters the study, a code is announced to the researcher, and the drug or placebo corresponding to that random code is given to the patient, and the said random code is recorded on the patient's file. If side effects are observed, the random code will be reopened, otherwise the codes will be reopened at the end of the study.
Blinding as:
Medicine and placebo will be prepared with the same shape, color and smell. Both placebo and drug will be prepared in the form of single capsules. Placebo capsules contain one gram of starch, which will be prepared in the clean room located in Rouhani Hospital.
Blinding (investigator's opinion)
Double blinded
Blinding description
The first colleague (student), the supervisor, the speech therapist and the patient are unaware of the random allocation list and which group each patient is in, and at the end of the study, they will be informed of the results using randomized codes by the data analyzer.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Health Research Institute of Babol University of Medical Sciences
Street address
Nurse St, University Square, Murad Bey, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.213
Health conditions studied
1
Description of health condition studied
Stuttering
ICD-10 code
F80.81
ICD-10 code description
Childhood onset fluency disorder
Primary outcomes
1
Description
Assessment of stuttering severity using the SSI-3 measurement tool by an evaluator (experienced speech therapist) and the SR score by the individual at the beginning of the study, 4 weeks and 10 weeks after the start of treatment during a visit to the clinic.
Timepoint
Zero, 4 and 10 weeks
Method of measurement
SSI-3 SR self-report form, AIMS, Connors hyperactivity test
Secondary outcomes
1
Description
Investigating the severity of stuttering using the SSI-3 measurement tool and the SR score
Timepoint
zero, four and ten weeks after the start of treatment
Method of measurement
Stuttering Severity Instrument-3
2
Description
Investigating the duration of recovery of stuttering based on SR and SSI-3 scores
Timepoint
zero, four and ten weeks after the start of treatment
Method of measurement
Self-Report Self-Report Form - Connors Hyperactivity
3
Description
Investigating age and gender differences in the group receiving risperidone
Timepoint
zero, four and ten weeks after the start of treatment
Method of measurement
Abnormal Involuntary Movement Scale (AIMS)
Intervention groups
1
Description
Intervention group:Intervention group: Patients in the drug group were treated with risperidone with a nightly unit dose of half a milligram and a maximum nightly unit dose of up to two milligrams based on the patient's tolerance and symptoms (Soban Pharmaceutical Company) along with speech therapy by two experienced speech therapists.
Category
Treatment - Drugs
2
Description
Control group: Control group: The other group will be treated with speech therapy with placebo (a capsule containing starch with the same shape and color as the drug in the intervention group).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Yahya Nejad Babol Hospital
Full name of responsible person
Dr. Arman Masoudi
Street address
Shahid Mustafa Khomeini Street, Modares Street, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3222 3594
Email
Yahyalib97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Mehdi Rajab Nia
Street address
Nurse Street, University Square, Murad Bey, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 9592
Email
elhammotevali7@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?