Protocol summary

Study aim
effectiveness of a mixed program of emotional socialization and Familly accommodation in improving anxiety, emotional regulation, and functional outcomes
Design
Parallel group. The sample size is 80 people divided into four groups of 20 people.After initial screening, the names of the participants in the research are arranged without any order. By throwing a dice and identifying a number, four groups are formed and again assigned the control group and the intervention with the lottery of the groups.
Settings and conduct
This research will be conducted in Malayer and in elementary schools.
Participants/Inclusion and exclusion criteria
Mother of 6 to 8 year olds literate mothers / willingness to participate in research conditions child being ill
Intervention groups
Control Emotional socialization Familly accommodation mixed of emotional socialization and Familly accommodation
Main outcome variables
Improving anxiety, emotional regulation, and functional outcomes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190111042325N1
Registration date: 2019-04-14, 1398/01/25
Registration timing: retrospective

Last update: 2019-04-14, 1398/01/25
Update count: 0
Registration date
2019-04-14, 1398/01/25
Registrant information
Name
Maryam Hassanzadeh Aval
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 81 3222 0188
Email address
hassanzadeh.maryam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Emotional dysregulation in child anxiety: effectiveness of a mixed program of emotional socialization and parenting accommodation in improving anxiety, emotional regulation, and functional outcomes
Public title
emotional dysregulation in child anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age of child between 6 and 8 years educated mothers willingness to participate in research
Exclusion criteria:
Not having a parent Mother or child suffered a debilitating physical illness (such as cardiovascular diseases, cancer, multiple sclerosis) (according to parents)
Age
From 6 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
After initial screening, the names of the participants in the research are arranged without any order. By throwing a dice and identifying a number, four groups are formed and again assigned the control group and the intervention with the lottery of the groups.
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
Ethics Committee of Ferdowsi University
Street address
Freedom Square, Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
ir.um.rec.1397.057

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
improving anxiety
Timepoint
Before and after the intervention, and follow up to 6 months
Method of measurement
questionnaire

Secondary outcomes

1

Description
functional outcomes
Timepoint
per and post of intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: emotional socialization. The intervention lasts six sessions and is given training sessions on anxiety, development of emotions, labeling, and modeling emotional regulation. All tutorials are delivered as lectures and practice sessions.
Category
Behavior

2

Description
Intervention group: Family. accommodation. This intervention takes 6 sessions and takes place in sessions on anxiety, identification of reassurance and its replacement with effective coping, identification of intervention and radical guidance and its replacement with the modeling of courageous behavior, identifying allowing it to be avoided and replacing it with rewarding behaviors Courageous, identifying the indignity and replacing it by ignoring the mother's teachings. All tutorials are delivered as lectures and practice sessions.
Category
Behavior

3

Description
Intervention group: mixed program of emotional socialization and Family accommodation. The combination of the two previous interventions, takes ten sessions.
Category
Behavior

4

Description
Control group: There is no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
15 public school
Full name of responsible person
Maryam Hassanzadeh Aval
Street address
Azadi, Rajaei
City
Malayer
Province
Hamadan
Postal code
6571967154
Phone
+98 81 3222 0188
Email
hassanzadeh.maryam@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of University of Ferdowsi Mashhad
Full name of responsible person
Maryam Hassanzadeh Aval
Street address
Ferdowsi University, Azadi Squere
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
hassanzadeh.maryam@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of University of Ferdowsi Mashhad
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
Ali Mashhadi
Position
Associate Professor of Clinical Child & Adolescent Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 985138803555
Fax
Email
mashhadi@um.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Ferdowsi Mashhad
Full name of responsible person
Maryam Hassanzadeh Aval
Position
Ph.d Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Azadi, Rajaei
City
Malayer
Province
Hamadan
Postal code
6571967154
Phone
+98 81 3222 0188
Email
hassanzadeh.maryam@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Ferdowsi Mashhad
Full name of responsible person
Maryam Hassanzadeh Aval
Position
Ph.d Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Azadi, Rajaei
City
Malayer
Province
Hamadan
Postal code
6571967154
Phone
+98 81 3222 0188
Email
hassanzadeh.maryam@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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