Protocol summary

Study aim
Construction and validation of the migration grief assessment tool for children and adolescents and the design of the migration grief intervention based on the complex grief treatment model (CGT)
Design
This research will be a semi-experimental study with an intervention group and a control group, without blinding, randomized on 20 people. Randomization was done in order to allocate samples in the control and experimental groups in a simple way using the website sealedenvelope.com.
Settings and conduct
After the construction and validation of the migration grief questionnaire, sampling will be done by filling out the said questionnaire online from Iranians living in Canada, then 20 people will be selected from the eligible applicants based on the results of the test. and will be randomly placed in the experimental and control groups. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
The person must be between 10 and 13 years old and at least 6 months and a maximum of 12 months have passed since the person entered the host country..
Intervention groups
Experimental group: they receive the intervention related to migration grief. Control group: This group does not receive any effective intervention.
Main outcome variables
Migration bereavement symptoms, Self-efficacy, Social acceptance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231203060252N1
Registration date: 2024-01-20, 1402/10/30
Registration timing: prospective

Last update: 2024-01-20, 1402/10/30
Update count: 0
Registration date
2024-01-20, 1402/10/30
Registrant information
Name
Talayeh Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 5285
Email address
talayeh_abbasi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The design of child migratory grief assessment and intervention based on complicated grief therapy model (CGT) and its effectiveness on improvement of migratory grief symptoms, self efficacy and social acceptance in immigrant children.
Public title
Migratory grief among children, assessment and intervention
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All children and adolescents whose emigration bereavement score is significant in the emigration bereavement questionnaire At least 6 months have passed since their arrival in the destination country. The age range of the participants should be between7 and 16 years. This migration mourning has caused a significant drop in their performance. This immigration mourning has significantly reduced the level of life satisfaction in a person.
Exclusion criteria:
Less than 6 months have passed since entering the destination country.
Age
From 8 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
More than 1 sample in each individual
Number of samples in each individual: 3
Before the intervention, after the end of the intervention, three months later as a follow-up.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done in a simple way using the website sealedenvelope.com. Randomization is done using block. Based on the randomization software, the subjects will be grouped into blocks of four and will be placed in the intervention group and the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
This research actually pursues two main goals, which in the first step is diagnostic (developing a questionnaire) and in the second step is supportive (intervention).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Medical Faculty of Islamic Azad University, Mashhad Medical Sciences Unit.
Street address
NO29, Sayad shirazi28 Ave.Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9179135963
Approval date
2023-10-25, 1402/08/03
Ethics committee reference number
IR.IAU.MSHD.REC.1402.145

Health conditions studied

1

Description of health condition studied
Migratory grief
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Migratory grief symptoms
Timepoint
Before the start of the intervention, after the end of the intervention, two months after the end of the intervention.
Method of measurement
Migratory grief assessment Questionnaire

2

Description
Self Efficacy
Timepoint
before the start of the intervention - after the end of the intervention - two months after the end of the intervention
Method of measurement
The Self-Efficacy Questionnaire for Children (SEQ-C) by mouris

3

Description
social acceptance
Timepoint
Before the start of the intervention, after the end of the intervention, two months after the end of the intervention
Method of measurement
Social Acceptability Questionnaire (SAQ) BY Fourd and Rabin

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: This group participates in the intervention sessions related to the treatment protocol of migration grief in a structured way.
Category
Treatment - Other

2

Description
Control group: This group will not receive any effective intervention related to migration soup and other dependent variables.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
امور کنسولی ایرانیان مقیم کانادا
Full name of responsible person
Talayeh Abbasi
Street address
Building No. 3 of the Ministry of Foreign Affairs, Imam Khomeini Square, Mashq Square
City
Tehran
Province
Tehran
Postal code
1136914811
Phone
+98 21 6115 3278
Email
ecs@mfa.gov.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
rahim dabiri
Street address
Islamic Azad University of Mashhad, Ostad Yousefi intersection, Emamieh Blvd, Qasim Abad, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3891 2073
Email
talayeh_abbasi@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
Talayeh Abbasi
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 29, 28 Sayad Shirazi, Sayad Shirazi Boulevard -
City
Mashhad
Province
Razavi Khorasan
Postal code
9179135963
Phone
+98 51 3869 5285
Email
talayeh_abbasi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Talayeh abbasi
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 29, Sayad Shirazi 28, Sayad Shirazi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9179135963
Phone
+98 51 3869 5285
Email
talayeh_abbasi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Talayeh Abbasi
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 29 Sayad Shirazi 28 Sayad Shirazi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9179135963
Phone
+98 51 3869 5285
Email
talayeh_abbasi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
The data related to the results of the questionnaires completed by the participants will be visible in three stages before the intervention, after the intervention and after two months of follow-up.
When the data will become available and for how long
Access will start simultaneously with the publication of articles related to the project
To whom data/document is available
All academic people who are interested in the results of this research.
Under which criteria data/document could be used
Using data in scientific articles by mentioning the source will be approved.
From where data/document is obtainable
Talayeh Abbasi via email talayeh_abbasi@yahoo.com
What processes are involved for a request to access data/document
Receiving email and checking the applicant's scientific employment status and sending the required information within 2 working weeks
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