Effects of community based intervention focused on the comprehensive nurturing care of the child on parent-child communicative styles and lexical development of 12-24 month old children
Effects of community-based intervention focused on the comprehensive nurturing care of the child on parent-child communicative styles and lexical development of 12-24 months old children
Design
Randomized, Community-based, parallel group trial on 140 children
Settings and conduct
The study field: Mashhad city. The tools used for the intervention included two mobile health applications, MAHAK and HAK and short educational videos produced by the research team to demonstrate appropriate techniques for mother-child interaction.
The duration of the study for all subjects will be 6 months from the time of enrollment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
12- to 24-months old children who:
are Monolingual speaker of Persian
are from Middle or lower socio-economic class
have poor language and communicative skills (Based on MacArthur-Bates CDI)
are typical in all developmental areas except language and communication, based on ASQ and Bayley III.
have literate parents. one parent has a smartphone and know how to work with it, and signed the consent form
Exclusion criteria:
Parents' not willing to participate in the study
Intervention groups
Intervention group 1: 12-24 months old children from lower class families who receive the intervention.
Intervention group 2: 12-24 months old children from to the middle class families who receive the intervention.
Control group 1: 12-24 months old children from lower class families who don't receive the intervention.
Control group 2: 12-24 months old children from to the middle class families who don't receive the intervention.
Main outcome variables
Child Score on MacArthur-Bates Communicative Development Inventories- checklist 2
Scores obtained via coding and analyzing the interactive and linguistic samples
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191214045730N1
Registration date:2022-02-24, 1400/12/05
Registration timing:registered_while_recruiting
Last update:2022-02-24, 1400/12/05
Update count:0
Registration date
2022-02-24, 1400/12/05
Registrant information
Name
Toktam Maleki Shahmahmood
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6710
Email address
malekist@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of community based intervention focused on the comprehensive nurturing care of the child on parent-child communicative styles and lexical development of 12-24 month old children
Public title
Effects of community based intervention focused on the comprehensive nurturing care of the child on parent-child communicative styles and lexical development of 12-24 month old children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 12 to 24 months
Having verbal and communication skills below the expected level for age, based on the scores in the Persian version of the MacArthur-Bates Communicative Development Inventories- checklist 1 / 2
Having age-appropriate performances in all developmental domains (except for verbal communication) based on the Persian version of the Ages and Stages Questionnaire (ASQ) and the Bayley Scales of Infant and Toddler Development
Classified in middle or lower socioeconomic classes based on the researcher-made questionnaire of socio-demographics
No history of neurological defects; problems such as low birth weight (less than 1500), hypoxia at birth, head trauma, sensory deficits (in vision/ hearing), seizures end, etc.
Patients' parents are monolingual Persian speakers, literate, have a mobile phone to receive educational files and know how to work with it / be able to learn it
Exclusion criteria:
Parents' not willing to participate in the study
Age
From 12 months old to 24 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
First, individuals would be allocated to one of middle or low socio-economic classes based on the information obtained from the socio-economic questionnaire. For random allocation of the subjects of each SES class to one of the intervention or control groups, block randomization method (4 blocks) will be used. In each block, 2 individuals are assigned to the intervention group and 2 people to the control group. For each block, random sequences will be generated by Random allocation software and then, concealed in sequentially numbered, sealed, opaque envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Mashhad University of Medical Sciences
Street address
Khorasan Razavi, Mashhad, East door of Ferdowsi University, Public Relations Department of the University (Tardarandshjoo), Website Unit
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Approval date
2021-07-25, 1400/05/03
Ethics committee reference number
IR.MUMS.FHMPM.REC.1400.050
Health conditions studied
1
Description of health condition studied
late talker
ICD-10 code
R62.0
ICD-10 code description
Delayed milestone in childhood
Primary outcomes
1
Description
vocabulary size (comprehension and production scores)
Timepoint
Before study, after study
Method of measurement
Persian version of MacArthur-Bates Communicative Development Inventories
Secondary outcomes
1
Description
parent- child communicative behaviors
Timepoint
after intervention
Method of measurement
structural analysis of mother-child free play
Intervention groups
1
Description
Intervention group1: 12 to 24 months old late talkers from middle socioeconomic class whose parents receive 2 mobile health applications (named comprehensive child care application (MOHAK) and the art of communicate with the child through love, talking, playing and reading (HAK)), as well as 14 short educational videos about the appropriate mother-child interactions styles on their smart phone, in addition to common counselling interventions by speech therapists. Parents, will have 3 to 5 individual 45-minute sessions with the researchers to learn about working with the apps, scheduling files, and using from age-appropriate contents in daily routine situations. They will give weekly reports to researchers and will receive appropriate corrective/confirmatory feedbacks from them. The duration of the intervention period will be 6 months from the time of enrolment.
Category
Behavior
2
Description
Intervention group: 12 to 24 months old late talkers from lower socioeconomic class. These children will receive the same intervention as the intervention group 1.
Category
Behavior
3
Description
Control group1: 12 to 24 months old late talkers from middle socioeconomic class who receive no intervention other than common counselling interventions by speech therapists.
Category
Behavior
4
Description
Control group 2: 12 to 24 months old late talkers from lower socioeconomic class who receive no intervention other than common counselling interventions by speech therapists.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers, State Health Center / Vice Health, Mashhad university of medical scie
Full name of responsible person
Dr Seyyed Javad Hosseini
Street address
Sanabad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185684538
Phone
+98 51 3841 5222
Email
health@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Daneshgah Ave., beside the Hoveyze movie theater, Ghoreiyshi building,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Toktam Maleki Shahmahmood
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
East door of Ferdowsi University, Public Relations Department of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 9152
Email
malekist@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Toktam Maleki Shahmahmood
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
East door of Ferdowsi University, Public Relations Department of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 9153
Email
malekist@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
toktam Maleki Shahmahmood
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
East door of Ferdowsi University, Public Relations Department of the University
City
mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 9152
Email
malekist@mums.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
size of productive /comprehensive vocabulary of children
lexical, semantic and communicative indexes extracted from language and interactive samples
When the data will become available and for how long
6 months after publication
To whom data/document is available
researchers and clinicians
Under which criteria data/document could be used
A variety of linguistic analyzes are allowed on the data
From where data/document is obtainable
Dr. Toktam Maleki Shahmahmood
Email: malekist@mums.ac.ir
What processes are involved for a request to access data/document
Data will be sent immediately after the request and stating the reason for the request.