Investigation of the efficacy of Risperidone in the treatment of developmental stuttering in Persian-speaking children aged 5 to 10 years

Phase 3

Recruiting

Conditions: Stuttering.
F80.81
Childhood onset fluency disorder

Registration Number: IRCT20240527061909N1

Lead Sponsor: Babol University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.;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.;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).