Protocol summary
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Study aim
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The aim of this study is investigating the effect of consultacy of play therapy on social evolution (social maturity) of 12 to 24 months old children referring to selected comprehensive health centers in Kashan.
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Design
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]n this study, 76 children from 12 to 24 months old who have been admitted to the study who visit the comprehensive health centers of the city of Kashan, are selected, and the social maturity scale is completed, if their score is less than half the full score. The randomization is divided into two groups of intervention and control and each participant is assigned a code.
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Settings and conduct
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The sampling method will be multistage, so that: firstly, three centers will be selected from the centers of the township, and in each center, according to the population of children aged one to two, available sampling according to the criteria for entering the research will be done. After selecting eligible individuals, they are randomly assigned to two groups of intervention and control.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria The parents have at least literacy to read and write, be Iranian, 12 - 24 months old children whose age is Based on social growth scale, be at least one second year less than their calendar age, The child does not have known physical and mental illness, Parents’ Satisfaction to Participate in the Study and Exit criteria Mothers' reluctance to continue to participate in the study, not attending maximum two sessions of consultancy sessions of play therapy, having any kind of physical and mental disabilities.
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Intervention groups
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Intervention group In this group, in addition to routine child care training and delivery of training packages, 6 sessions that are 30 minutes and weekly 2 sessions of group consultancy of play therapy will be held,Control group they will receive ministry’s routine training and training packages.
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Main outcome variables
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Increase the developmental score of children from 12 to 24 months
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160503027728N8
Registration date:
2018-01-11, 1396/10/21
Registration timing:
prospective
Last update:
2018-01-11, 1396/10/21
Update count:
1
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Registration date
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2018-01-11, 1396/10/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-01-21, 1396/11/01
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Expected recruitment end date
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2018-06-22, 1397/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of consultancy of play therapy on social evolution (social maturity) of 12-24 months old children referring to selected comprehensive health centers in Kashan 1396-1397
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Public title
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Investigating the effect of consultancy of play therapy on social evolution (social maturity) of 12-24 months old children referring to selected comprehensive health centers in Kashan 1396-1397
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
The parents have at least literacy to read and write
12 - 24 months old children whose age is Based on social growth scale, be at least one second year less than their calendar age
be Iranian
The child does not have known physical and mental illness
Parents’ Satisfaction to Participate in the Study
Exclusion criteria:
Mothers' reluctance to continue to participate in the study,
not attending maximum two sessions of consultancy sessions of play therapy,
having any kind of physical and mental disabilities.
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Age
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From 12 months old to 24 months old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Available sampling and random blocks
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-30, 1396/10/09
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Ethics committee reference number
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Abzums.Rec.1396 .136
Health conditions studied
1
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Description of health condition studied
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The social development of children 12-24 months
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ICD-10 code
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Z31.6
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ICD-10 code description
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Encounter for general counseling and advice on procreation
Primary outcomes
1
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Description
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Social maturity of the child in Vineland scale
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Timepoint
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Before intervention and at the end of the consultation sessions
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Method of measurement
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Use of Social maturity of Vineland scale
Intervention groups
1
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Description
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Intervention group: this group, in addition to routine child care training and delivery of training packages, 6 sessions that are 30 minutes and weekly 2 sessions of group consultancy of play therapy will be held
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Category
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Behavior
2
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Description
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Control group:they will receive ministry’s routine training and training packages.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Alborz University Of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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as an English article we published data.
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When the data will become available and for how long
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10 month later
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To whom data/document is available
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Alborz & Kashan University Of Nursing and Midwifery
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Under which criteria data/document could be used
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Path analysis
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From where data/document is obtainable
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Dr Zohreh Mahmoodi
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What processes are involved for a request to access data/document
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send an email to Dr. Zohreh Mahmoodi
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Comments
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