Protocol summary

Study aim
The general objective of the study is to determine the effect of group work intervention with the TRT method on post-traumatic stress symptoms in Afghan asylum-seeking adolescent girls in Iran.
Design
A controlled, parallel-group, single-blind, randomized clinical trial. sealed envelope randomization is used in the study.
Settings and conduct
The location of the study will be NGOs that provide services to immigrants (Mehromah NGO and Arfak NGO). Sampling has not been done yet.
Participants/Inclusion and exclusion criteria
Afghan teenage girls who entered Iran after the Taliban came to power in Afghanistan in 1400. Inclusion criteria: • Age 14 to 17 years • A score of 17 or higher on the Impact of Event Scale-Revised • Introducing a person over 18 years as the participant's caregiver • Informed assent and informed consent of the teenager and her legal guardian to participate in the research
Intervention groups
In the intervention group, the intervention of Teaching Recovery Techniques (TRT) will be carried out, which includes 5 sessions for teenagers and 1 session for their caregivers. 6 sessions of origami workshop will be held for the control group.
Main outcome variables
The symptoms of post-traumatic stress including avoidance, hyperarousal, and intrusive thoughts are the variables, which, if they are reduced, the main outcome is obtained through intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220710055430N1
Registration date: 2023-07-03, 1402/04/12
Registration timing: retrospective

Last update: 2023-07-03, 1402/04/12
Update count: 0
Registration date
2023-07-03, 1402/04/12
Registrant information
Name
Sarvenaz Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6635 8894
Email address
sarvenazahmadi1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-19, 1401/04/28
Expected recruitment end date
2022-10-20, 1401/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of group work intervention with Teaching Recovery Techniques (TRT) method on post-traumatic stress symptoms in Afghan asylum-seeking adolescent girls in Iran
Public title
effect of Teaching Recovery Techniques (TRT) on post-traumatic stress symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 14 to 17 years A score of 17 or higher on the Impact of Event Scale-Revised Introducing a person over 18 as the participant's caregiver The teenager and her legal guardian informed consent and informed assent to participate in the research
Exclusion criteria:
Age
From 14 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed Envelope simple individual randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of social welfare and rehabilitation sciences
Street address
Koodakyar DE., Daneshjoo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2022-10-22, 1401/07/30
Ethics committee reference number
IR.USWR.REC.1401.133

Health conditions studied

1

Description of health condition studied
post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)

Primary outcomes

1

Description
Posttraumatic stress symptoms score on the Impact of Event Scale-Revised
Timepoint
Measurement of post-traumatic stress symptoms at the beginning of the study (before the intervention) and 1 month after the intervention
Method of measurement
Impact of Event Scale-Revised questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 6 sessions of Teaching Recovery Techniques (TRT) intervention
Category
N/A

2

Description
Control group: 6 sessions of origami workshop
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr-o-Mah empowerment center
Full name of responsible person
Afkham Sabbagh
Street address
No. 4, Amouei Alley, Emamzade Davoud St., Farahzad
City
Tehran
Province
Tehran
Postal code
1981743583
Phone
+98 21 2238 2665
Email
mehromah.far@gmail.com

2

Recruitment center
Name of recruitment center
Arfak NGO
Full name of responsible person
Moein Kamrani
Street address
No. 24, Babaraeisi Alley, Saheb jam' St., Shoosh
City
Tehran
Province
Tehran
Postal code
1168835361
Phone
+98 21 5559 0622
Email
info@arfak.org
Web page address
https://arfak.org/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khankeh
Street address
Koodakyar DE., Daneshjoo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
pr@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Sarvenaz Ahmadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Social Services
Street address
Koodakyar DE., Daneshjoo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 6635 8894
Email
sarvenazahmadi1998@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Sarvenaz Ahmadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Social Services
Street address
Koodakyar DE., Daneshjoo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 6635 8894
Email
sarvenazahmadi1998@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Sarvenaz Ahmadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Social Services
Street address
Koodakyar DE., Daneshjoo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 6635 8894
Email
sarvenazahmadi1998@gmail.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The start of the access period from the winter of 1401 (estimated)
To whom data/document is available
Everybody can receive this data.
Under which criteria data/document could be used
Any use of the documentation is permitted.
From where data/document is obtainable
Sarvenazahmadi, the principal researcher, can be contacted at sarvenazahmadi1998@gmail.com.
What processes are involved for a request to access data/document
The applicant can access the data up to 1 month after the request.
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