The Effects of the Family Centered Approach on the Communication Skills of Typical Toddlers from Low Socioeconomic Status (SES) Families: A Pilot Study
The effect of Family Centered Therapy on Communication Skills of Persian Toddlers, Aged 12-14 Month
Design
It will be a randomized controlled trial, with a control group, permuted block randomization, single blind. children will be divided in three different groups based on pretest on their vocabulary: 1) with less than 10 words, 2) between 10 and 20 words and 3) more than 20 words. Group 3 will be excluded. The statistician will divide the group 1 and 2 in two groups of control and experimental. Families do not know what group they are going to be, only the speech therapist knows.
Settings and conduct
This study will be done in different health centers located in low SES residency areas such as Maskan Mehr, Jahadiyeh, & Abuzar in Semnan.
Participants/Inclusion and exclusion criteria
1- Families who have children aged between 12 and 14 months
2- Children who have a typical history in their milestones based on ASQ
3- Families who present a signed consent form
4- Mothers without history of depression
5- Parents speak Persian
6- Children who have less than 20 words in their expressive lexicon
7- Parents will not reveal any specific developmental, medical or family problems during the interviews
8- Mothers report a safe pregnancy an ddelivery
Intervention groups
The experimental group will participate in 4 workshops, each two hours, during 8 weeks. The control group will not have any workshop. In these workshops, mothers will receive education on their children's communication skills in this age, how they can support their toddlers and help them to develop their language, communicative and cognitive skills. Both groups will report their children's lexicons on MC-Arthur Bates form before, in the middle and at the end of the intervention.
Main outcome variables
The workshops content can be used to prevent developmental language disorders.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180612040069N1
Registration date:2018-07-04, 1397/04/13
Registration timing:registered_while_recruiting
Last update:2018-07-04, 1397/04/13
Update count:0
Registration date
2018-07-04, 1397/04/13
Registrant information
Name
Masoomeh Salmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3346 8920
Email address
salmani_masoome@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of the Family Centered Approach on the Communication Skills of Typical Toddlers from Low Socioeconomic Status (SES) Families: A Pilot Study
Public title
Family Centered Approach for Toddlers from Low SES
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children should be in the age limit (12-14 months)
Children had a history of typical milestones confirmed by the health staff
Children's expressive lexicon contains 20 or less words
Children without any history of delay, or disorders,
based on ASQ children have typical development
parents signed the consent form
No history of depression in mothers
only Persian language (no other dialects such as Gilaki, or language ex. English)
A history of a safe pregnancy-delivery
Exclusion criteria:
Age
From 12 months old to 14 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
It will be a randomized controlled trial, with a control group, permuted block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
children will be divided in three different groups based on pretest on their vocabulary: 1) with less than 10 words, 2) between 10 and 20 words and 3) more than 20 words. Group 3 will be excluded. The statistician will divide the group 1 and 2 in two groups of control and experimental. Families do not know what group they are going to be, only the speech therapist knows.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Semnan University of Medical Sciences
Street address
Research Affairs, Main Campus of Semnan University of Medical Sciences, Amirkabir Square, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
IR.SEMUMS.REC.1397.005
Health conditions studied
1
Description of health condition studied
The Effect of Family Centered Approach on Children's Lexicons from Low SES Families
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in children's expressive and receptive scores
Timepoint
The evaluation will happen in week1, 5 and 9.
Method of measurement
Mc-Arthur Bates Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 mothers who have children aged between 12 and 14 months, with education at or below high school diploma from low SES residency areas will participate in 4 workshops during 8 weeks.
Category
Prevention
2
Description
Control group: 50 mothers who have children aged between 12 and 14 months, with education at or below high school diploma from low SES residency areas will report their children's lexicons on Mc-Arthur Bates in the first week and eight weeks later.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohaghegh
Full name of responsible person
Masoomeh Salmani
Street address
Speech and Language Therpay Deprtment, Rehabilitation Faculty, Semnan University of Medical Sciences, 5 km. of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
٣٨١١١-٣٥١٣١
Phone
+98 23 3365 4180
Email
Salmani_m@semums.ac.ir
2
Recruitment center
Name of recruitment center
17 Shahrivar
Full name of responsible person
Masoomeh Salmani
Street address
Speech and Language Therpay Deprtment, Rehabilitation Faculty, Semnan University of Medical Sciences, 5 km. of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
٣٨١١١-٣٥١٣١
Phone
+98 23 3365 4180
Email
Salmani_m@semums.ac.ir
3
Recruitment center
Name of recruitment center
Jahadiyeh
Full name of responsible person
Masoomeh Salmani
Street address
Speech and Language Therpay Deprtment, Rehabilitation Faculty, Semnan University of Medical Sciences, 5 km. of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
٣٨١١١-٣٥١٣١
Phone
+98 23 3365 4180
Email
Salmani_m@semums.ac.ir
4
Recruitment center
Name of recruitment center
Maskan Mehr
Full name of responsible person
Masoomeh Salmani
Street address
Speech and Language Therpay Deprtment, Rehabilitation Faculty, Semnan University of Medical Sciences, 5 km. of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
٣٨١١١-٣٥١٣١
Phone
+98 23 3365 4180
Email
Salmani_m@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhayi
Street address
Research Affaires, Main Campus of Semnan University of Medical Sciences, Amirkabir Square, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
35131-38111
Phone
+98 23 3344 1022
Email
salmani_m@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Masoomeh Salmani
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Speech and Language Therpay Deprtment, Rehabilitation Faculty, Semnan University of Medical Sciences, 5 km. of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35131-38111
Phone
+98 23 3365 4180
Email
salmani_m@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Masoomeh Salmani
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Speech and Language Therpay Deprtment, Rehabilitation Faculty, Semnan University of Medical Sciences, 5 km. of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35131-38111
Phone
+98 23 3365 4180
Email
salmani_m@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Masoomeh Salmani
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Speech and Language Therpay Deprtment, Rehabilitation Faculty, Semnan University of Medical Sciences, 5 km. of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35131-38111
Phone
+98 23 3365 4180
Email
salmani_m@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available