Determining the effect of emotional regulation training on the relationship between mothers and attention-deficit hyperactive disorder
Design
Clinical practice, pre-test and post-test plan, case and control group, 40 people in each group randomly
Settings and conduct
After obtaining informed consent from mothers who referred to welfare centers and explaining the research goals, mother_child relationship evaluation questionnaire will be completed in both the intervention and control groups, and then the intervention group will be trained emotion regulation based on the Grass model, in 8 sessions each session 90 minutes, once in a week. One month after the end of training sessions, questionnaires will be distributed simultaneously in intervention group and control group. During the training period of intervention group, control group will receive routine training like all centers. Participants in the intervention group would imagine that the other group will be trained after ending their sessions due to lack of space, so that "training sessions" cause no orientation in completing the second phase questionnaire
Participants/Inclusion and exclusion criteria
Inclusion criteria included mothers with at least one child with attention-deficit hyperactive disorder and no previous history of presence in emotional regulation sessions and not using psychiatric medications. Exclusion criteria included mothers had stress during last 6 months.
Intervention groups
Desired intervention in this study is training the emotional regulation to mothers with overactive children. Control group, if interested, will receive 8 training sessions after completing the second point questionnaire
Main outcome variables
Relationship between mothers with hyperactive children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042675N1
Registration date:2019-03-11, 1397/12/20
Registration timing:registered_while_recruiting
Last update:2019-03-11, 1397/12/20
Update count:0
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Zohre Arabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7713 9296
Email address
zohreharabi96@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2019-03-18, 1397/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of emotional regulation training on the relationship between mothers and attention-deficit hyperactivity disorder
Public title
The effect of emotion regulation on the relationship mothers with attention-deficit hyperactivity disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least one child with attention deficit/ hyperactivity disorder
Not having history of attending emotional regulation therapy sessions
Not to participate in the same interventions simultaneously
not to use psychosocial drugs in mothers
Not having a new stressor in mothers during the last 6 months
Not to use drugs by mother
Exclusion criteria:
Mental illness in the mother
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected by simple random sampling method and based on the criteria for entering the study, and then, according of participants list, random numbers are assigned to each participant, then a sortition is drawn between the numbers and each number allocated to intervention or control groups
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants will not know that they are member of intervention group or control group of study
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Medical Sciences Unit
Street address
Azad University of Medical Sciences, Danesh Alley, Attari Moghaddam Street, Zarganeh street, Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2018-10-31, 1397/08/09
Ethics committee reference number
IR.IAU.TMU.REC.1397.200
Health conditions studied
1
Description of health condition studied
relationship between mother and attention-deficit hyperactivity disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The relationship between mothers and attention- deficit hyperactivity disorder in the mother-child relationship evaluation
Timepoint
At the beginning of the study and one month after the training
Method of measurement
Mother-Child Relationship Evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the samples will complete the mother-child relationship questionnaire first. Then they will be trained emotion regulation, in 8 sessions each session 90 minutes, once in a week. Then, one month after the last session, they will complete the mother-child relationship questionnaire again. At the end, each sample will receive a emotion regulation training booklet prepared by researcher
Category
Behavior
2
Description
Control group: At first, samples completed the mother-child relationship questionnaire, but they will not receive any training. One month after completing emotional regulation training in the intervention group, the samples in the control group concurrently with the intervention group will again complete the mother-child relationship questionnaire and will receive the emotional regulation training if they wish
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadi Girls' Elementary School
Full name of responsible person
Nasrin Asad Beyk
Street address
Sadi Girls' Elementary School, Ja'far Panah Street, End of Jashnvare Street
City
Tehran
Province
Tehran
Postal code
1658654461
Phone
+98 21 7732 1514
Email
zohreharabi96@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Fatemeh Azizabadi Farahani
Street address
Azad University of Medical Sciences, Danesh Alley, Attari Moghaddam Street, Zarganeh street, Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
zohreharabi96@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Zohreh Arabi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 6, No.41, Talei Alley(Easterns Forth), South Takavaran Street, Delaavaran Blvd, Al-ghadir Square, Resalat Square
City
Tehran
Province
Tehran
Postal code
1687658363
Phone
+98 21 7713 9296
Email
zohrearabi96@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Arabi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 6, No.41, Talei Alley(Easterns Forth), South Takavaran Street, Delaavaran Blvd, Al-ghadir Square, Resalat Square
City
Tehran
Province
Tehran
Postal code
1687658363
Phone
+98 21 7713 9296
Email
zohreharabi96@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Arabi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 6, No.41, Talei Alley(Easterns Forth), South Takavaran Street, Delaavaran Blvd, Al-ghadir Square, Resalat Square
City
Tehran
Province
Tehran
Postal code
1687658363
Phone
+98 21 7713 9296
Email
zohreharabi96@yahoo.com
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
Yes - There is a plan to make this available
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
Total data of participants in the study after un identifying individuals will be shared. Study protocol, statistical analysis map and clinical study report will be fully shared
When the data will become available and for how long
beginning of access period to data will be 6 months after the results are printed
To whom data/document is available
Data and other study documents can be sent to all who are interested in this field
Under which criteria data/document could be used
Data will be provided to anyone who needs information in this area or to conduct similar research in this area, without any special conditions
From where data/document is obtainable
Applicants can contact e-mail at zohreharabi96@yahoo.com for gaining information
What processes are involved for a request to access data/document
Information will be sent to the applicant immediately after request by e-mai