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IRCT20191214045730N1 IRCT 2022-02-24 Mashhad University of Medical Sciences 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 month old children 2022-01-21 anticipated 140 Complete https://irct.ir/trial/60498 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A late talker. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Yes - There is a plan to make this available What will be shared: size of productive /comprehensive vocabulary of children lexical, semantic and communicative indexes extracted from language and interactive samples When: 6 months after publication To whom: researchers and clinicians Conditions: A variety of linguistic analyzes are allowed on the data Where to obtain: Dr. Toktam Maleki Shahmahmood Email: malekist@mums.ac.ir How to obtain: Data will be sent immediately after the request and stating the reason for the request. Comments:
public Toktam Maleki Shahmahmood
East door of Ferdowsi University, Public Relations Department of the University
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 9152 malekist@mums.ac.ir Mashhad University of Medical Sciences scientific Toktam Maleki Shahmahmood
East door of Ferdowsi University, Public Relations Department of the University
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 9153 malekist@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 12 months 24 months Both Parents' not willing to participate in the study R62.0 Delayed milestone in childhood Behavior Behavior Behavior Behavior 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. 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. 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. 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. Vocabulary size (comprehension and production scores). Timepoint: Before study, after study. Method of measurement: Persian version of MacArthur-Bates Communicative Development Inventories. Parent- child communicative behaviors. Timepoint: after intervention. Method of measurement: structural analysis of mother-child free play. Mashhad University of Medical Sciences Approved 2021-07-25 Ethic Committee of Mashhad University of Medical Sciences Khorasan Razavi, Mashhad, East door of Ferdowsi University, Public Relations Department of the University (Tardarandshjoo), Website Unit Mashhad Razavi Khorasan Iran (Islamic Republic of)