Protocol summary
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Study aim
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Developing a parental model based on attachment theory; and comparing the effectiveness of model with the model of parent-child-interaction-based play-therapy in depression, self-control and emotion of regulation of children aged 6-12 years with disruptive mood dysregulation disorder in city of Isfahan.
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Design
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Clinical groups in simple randomized: control, parental model based on attachment theory, and therapeutic-game model based on parent-child-interaction
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Settings and conduct
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45 parents of children with disruptive mood dysregulation disorder who are referred to the children's psychiatric center of the Noor branch of Isfahan, Khorshid medical complex, are selected based on entry criteria and randomly categorized to 3 groups, as follow: Training of parental model based on attachment theory-Training of therapeutic-game model based on parent-child-interaction-Control group under one individual training session on the subject.
Psychological evaluation in three stages as before, upon the completion of the intervention, and after 3 months follow-up
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Participants/Inclusion and exclusion criteria
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Diagnosis of disruptive mood dysregulation disorder of children aged 6- 12 years. Conscious consent to participate in the research.Physical and mental ability in order to attend the meetings.Education: finished elementary school, at least. Residency: city of Isfahan.Contact Number for invitation to participate in the intervention. Bipolar disorder.Opposition defiant disorder. Attention deficit hyperactivity disorder.Autism disorder. Participate in Psycho social or psychotherapy sessions over the past 6 months. Not being motivated to participate and continue in the intervention
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Intervention groups
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parental model based on attachment theory, therapeutic-game model based on parent-child-interaction, Participants in training waiting list
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Main outcome variables
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Self-control, depression, emotional of regulation
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:
IRCT20180623040196N1
Registration date:
2018-09-08, 1397/06/17
Registration timing:
registered_while_recruiting
Last update:
2018-09-17, 1397/06/26
Update count:
1
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Registration date
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2018-09-08, 1397/06/17
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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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2018-06-22, 1397/04/01
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Expected recruitment end date
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2018-09-22, 1397/06/31
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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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Developing a parental model based on attachment theory; and comparing the effectiveness of this model with the model of parent-child-interaction-based play-therapy in depression, self-control and emotion of regulation of children aged 6-12 years with disruptive mood dysregulation disorder in city of Isfahan.
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Public title
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Developing a parental model based on attachment theory and study its effectiveness on children with disordered disturbance disorder
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
disruptive mood dysregulation disorder of children aged 12- 10 years
Conscious consent to participate in the research
Physical and mental ability in order to attend the meetings
Education: finished elementary school, at least.
Residency: city of Isfahan
Contact Number for invitation to participate in the intervention
Exclusion criteria:
Bipolar disorder
Oppositional defiant disorder
attention deficit hyperactivity disorder
Autism disorder
Participate in Psychosocial or psychotherapy sessions over the past 6 months
Not being motivated to participate in the intervention
Unwillingness to continue participating in the intervention
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Age
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No age limit
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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:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple random sampling
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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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Examining the validity of the developed training package through qualitative method
Ethics committees
1
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Ethics committee
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Approval date
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2018-04-16, 1397/01/27
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Ethics committee reference number
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IR.IAU.KHUISF.REC.1397-013
Health conditions studied
1
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Description of health condition studied
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Disruptive mood dysregulation disorder
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ICD-10 code
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F34/8
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ICD-10 code description
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Primary outcomes
1
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Description
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Depression
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Timepoint
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Before the intervention, after the intervention, and three months after the end of the intervention
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Method of measurement
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Quakes Depression Inventory (1992)
2
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Description
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Self-control
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Timepoint
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Before the intervention, after the intervention, and three months after the end of the intervention
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Method of measurement
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Kendall Vickes Self Controller (1979)
3
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Description
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Emotion of regulation
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Timepoint
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Before the intervention, after the intervention, and three months after the end of the intervention
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Method of measurement
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ERQ short form questionnaire
Intervention groups
1
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Description
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Intervention group: Training of the package of parenting developed based on attachment theory
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Category
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Lifestyle
2
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Description
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Intervention group: Game therapy based on parenting and child relationships
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Category
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Treatment - Other
3
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Description
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Control group:One individual counseling session
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Category
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N/A
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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Yes
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Title of funding source
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Islamic Azad University
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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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Private
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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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Persons
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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be 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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The results of the research
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When the data will become available and for how long
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6 months after printing results
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To whom data/document is available
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Researchers working in academia and academia
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Under which criteria data/document could be used
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To report the results in other research studies by maintaining its source
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From where data/document is obtainable
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Islamic Azad University (Khorasgan Branch)
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What processes are involved for a request to access data/document
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Islamic Azad University (Khorasga), Central Library, Thesis Department
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Comments
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