Protocol summary

Summary
1) Objectives: The aim of the study is investigating the effectiveness of Melodic Intonation Therapy (MIT) on Persian autistic children's speech. (2) Design: An easy version of Melodic Intonation Therapy (MIT) based on Albert, et al.’s model (1973), adapted for Persian language is designed. All participants undergone MIT for 48 sessions, each 20-30 minute during 16 weeks. A single-subject design is employed to provide proof of concept of this intervention as a quasi-experimental study. All subjects are selected as available samples. (3) Setting and conduct: After a pilot, case study, on a 10 years old boy for one month, 13 subjects are selected for the main study in the Autism Center of Isfahan. (4) Participants: 13 Male; 7-10 year- old; Monolingual; Persian speaker; Right-handed; With a diagnosis of autism (diagnosis made by pediatric neurologists or psycho-neurologist prior to enrollment); Without major medical conditions other than ASD, Previously received speech therapy at least 12 months, Receptive language skills of >20 months, based on the Newsha developmental scale(Persian), (5) Intervention: Melodic intonation therapy. (6) Main outcome measures (variables): Speech quality variables such as; MLU (Mean Length of Utterance);speech rate, number of verbs and echolalia are measured after phonetic transcription. NEWSHA; Persian developmental scale is used for assessing the receptive and expressive language and speech skills.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013091614684N1
Registration date: 2013-11-16, 1392/08/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-16, 1392/08/25
Registrant information
Name
Neda Ferdosi
Name of organization / entity
Payame Noor University
Country
Iran (Islamic Republic of)
Phone
+98 21 2294 9454
Email address
ferdosi@phd.pnu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2011-10-22, 1390/07/30
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of melodic intonation therapy in decreasing autistic symptoms on 7-10 year old Persian male children
Public title
Melodic Intonation Therapy in the Persian Autistic Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male; 7-10 years; Monolingual; Persian speaker; Right-handed; With a diagnosis of autism (diagnosis made by pediatric neurologists or psycho-neurologist prior to enrollment; Without major medical conditions such as motor disabilities (e.g., cerebral palsy or tuberous sclerosis), Sensory disabilities (e.g., blindness or deafness), Genetic disorders (e.g., Down Syndrome) other than ASD; Previously received speech therapy at least 12 months; Receptive language skills of >20 months, based on the Newsha developmental scale(Persian); The ability to sit in a chair for more than 15 minutes; follow one-step commands without prompting; and imitate simple gross motor and oral motor movements such as clapping their hands; stomping their feet, and opening their mouth. exclusion criteria: New interventions based on prescription of child's physician.
Age
From 7 years old to 10 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 13
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Payame Noor University
Street address
Central Organization of Payame Noor University. Nakhl St, Mini city Blvd.
City
Tehran
Postal code
Approval date
2011-04-25, 1390/02/05
Ethics committee reference number
00

Health conditions studied

1

Description of health condition studied
Autism
ICD-10 code
F84
ICD-10 code description
Pervasive developmental disorders. Childhood autism A type of pervasive developmental disorder that is defined by: (a) the presence of abnormal or impaired development that is manifest before the age of three years, and (b) the characteristic type of abno

Primary outcomes

1

Description
Echolalia
Timepoint
Before MIT(T1), After MIT(T2) (4 months after T1)
Method of measurement
Record of Speech, Phonetic Transcription, Morpheme Count, Calculating echolalia percentage in speech output

2

Description
Mean Length of Utterance (MLU)
Timepoint
Before MIT(T1), After MIT(T2) (4 months after T1)
Method of measurement
Record of Speech, Phonetic Transcription, Morpheme Count, It is calculated by collecting 100 utterances spoken by a child and dividing the number of morphemes by the number of utterances.

3

Description
Speech Rate
Timepoint
Before MIT(T1), After MIT(T2) (4 months after T1)
Method of measurement
Record of Speech, Calculating word per minute in speech output

4

Description
Verb number average in sentence.
Timepoint
Before MIT(T1), After MIT(T2) (4 months after T1)
Method of measurement
Record of Speech, It is calculated by collecting the utterances spoken by a child and dividing the number of verbs by the number of utterances in speech output.

Secondary outcomes

1

Description
vowel frequency
Timepoint
Before MIT(T1), after MIT(T2) 4 months after T1.
Method of measurement
Record of single vowels, assessing fundamental frequency by using Praat software of acoustic phonetics.

2

Description
vowel Intensity
Timepoint
Before MIT(T1), after MIT(T2) 4 months after T1.
Method of measurement
Record of single vowels, assessing intensity by using Praat software of acoustic phonetics.

Intervention groups

1

Description
Intervention: Melodic Intonation Therapy ( Speech Therapy). Each participant will observe as his control. A single-subject design.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Autism Centre of Isfahan
Full name of responsible person
Mansureh Hemmatian
Street address
Shahin St, Imam Khomeini Ave, Jomhuri Sq.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Payame Noor University
Full name of responsible person
Ali Khodashahi
Street address
Central Organization of Payame Noor University, Nakhl St, Mini city Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Payame Noor University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hassan Ashayeri
Position
Professor, Dr.MD. of Neuropsychiatry
Other areas of specialty/work
Street address
Nezam St, Shahnazari St, Madar Sq, Mirdamad Ave.
City
Tehran
Postal code
Phone
+98 21 2222 1577
Fax
+98 21 2222 0946
Email
ashayerih.neuroscientist@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Neda Ferdosi
Position
Ph.D. of Linguistics
Other areas of specialty/work
Street address
Linguistics Department, Central Organization of Payame Noor University, Nakhl St, Mini city Blvd.
City
Tehran
Postal code
Phone
+98 21 2294 9454
Fax
+98 21 2294 3242
Email
n.ferd2000@gmail.com; n.ferd2000@yahoo.com; ferdosi@phd.pnu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Neda Ferdosi
Position
Ph.D. of Linguistics
Other areas of specialty/work
Street address
Linguistics Department, Central Organization of Payame Noor University, Nakhl St, Mini city Blvd.
City
Tehran
Postal code
Phone
+98 21 2294 9454
Fax
Email
n.ferd2000@gmail.com ; n.ferd2000@yahoo.com; ferdosi@phd.pnu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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