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Unified protocol for transdiagnostic treatment of emotional disorders in adolescents

Protocol summary

Study aim
Investigate the efficiency of the Unified protocol of transdiagnostic treatment for adolescent emotional disorders.
Design
The clinical trial is a single-subject experimental study, without a control group, voluntary and available sample selection method, non-random sampling, sample size of 10 people, including 5 female students and 5 of their parents, who are among the people who meet the entry and exit criteria of the project. have been selected, phase 2 on 10 participants.
Settings and conduct
The participants were selected based on the entry and exit criteria and participated in 13 to 21-session treatment sessions, integrated meta-diagnosis, which includes 8 modules, and each module can be implemented in several sessions at Shahid Motahari Girls' School in Tehran. At the beginning of module 1, at the end of module 4 and 8, and at the 1/5 month follow-up, the evaluations were repeated.
Participants/Inclusion and exclusion criteria
The research sample using the accessible method includes 5 students with entry conditions: 13-16-year-old girl living in Tehran; having social anxiety disorder; and exit conditions: no simultaneous participation in other treatment; Absence of suicidal or suicidal thoughts, drug and alcohol abuse, absence of psychotic disorder of self or parents, absence of major academic failure, absence of history of psychiatric hospitalization in the last 6 months, education below 9 grades and absence of participation in at least 3 modules of treatment.
Intervention groups
The therapeutic intervention of the Unified protocol for the transdiagnostic treatment of adolescent emotional disorders has been implemented on 5 adolescent girls and their parents (mother).
Main outcome variables
Social anxiety; Depressive symptoms

General information

Reason for update
Acronym
UP-A
IRCT registration information
IRCT registration number: IRCT20230608058424N1
Registration date: 2023-08-07, 1402/05/16
Registration timing: retrospective

Last update: 2023-08-07, 1402/05/16
Update count: 0
Registration date
2023-08-07, 1402/05/16
Registrant information
Name
Zeynab Lashani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5595 1581
Email address
zeynablashani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-25, 1401/04/04
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
2022-06-25, 1401/04/04
Actual recruitment end date
2022-11-21, 1401/08/30
Trial completion date
2022-11-21, 1401/08/30
Scientific title
Unified protocol for transdiagnostic treatment of emotional disorders in adolescents
Public title
Unified protocol for transdiagnostic treatment of emotional disorders in adolescents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescent girl Live in Tehran With social anxiety disorder Age 13-16 year Informed consent
Exclusion criteria:
Non-participation in simultaneous treatment Suicidal ideation or thought of murder Drug and alcohol abuse Psychosis in person or parents Major educational failure Psychiatric hospitalized in the last six months Education less than 9 classes Absence of participation in at least 3 modules of therapy
Age
From 13 years old to 16 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 5
Actual sample size reached: 5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahed university
Street address
Shahed university, in front of Imam Khomeini's Holy Shrine, At the beginning of Azad Road Tehran-Qom
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2022-07-04, 1401/04/13
Ethics committee reference number
IR.SHAHED.REC.1401.031

Health conditions studied

1

Description of health condition studied
Social phobia disorder
ICD-10 code
F40.1
ICD-10 code description
Social phobias

Primary outcomes

1

Description
Social anxiety score in SPIN questionnaire
Timepoint
The beginning of module 1, the end of modules 4 and 8, and 1/5 month follow-up
Method of measurement
Spin questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: An Unified protocol for the transdiagnostic treatment of adolescent emotional disorders, which has 8 modules and between 12 and 21 treatment sessions for adolescents and 1 to 3 training sessions for parents.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Girls' School
Full name of responsible person
Zahra Jafar Karimi
Street address
Shahid Motahari Girls' School, Seirfipour Alley, before Sarcheshmeh, Baharestan Square, Tehran
City
Tehran
Province
Tehran
Postal code
۱۱۵۷۶۱۳۱۱۷
Phone
+98 21 3392 1323
Email
maaref_motahari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Rasoul Roshan Chesli
Street address
At the beginning of Azad Road, Tehran, Qom, in front of Imam Khomeini's Holy Shrine, Shahid University
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3565
Email
publicrelation@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
10
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
Shahed University
Full name of responsible person
Zeynab Lashani
Position
Clinical psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
2nd floor, Unit 3, No. 16, Misagh 3, Dasar St , Shahid Gheybi Square, Ray Tehran.
City
Tehran
Province
Tehran
Postal code
1843893744
Phone
+98 21 5595 1581
Email
zeynablashani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Zeynab Lashani
Position
Clinical psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
2nd floor, Unit 3, No. 16, Misagh 3, Dasar St , Shahid Gheybi Square, Ray Tehran.
City
Rey
Province
Tehran
Postal code
1843893744
Phone
+98 21 5595 1581
Email
zeynablashani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Zeynab Lashani
Position
Clinical Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
2nd floor, Unit 3, No. 16, Misagh 3, Dasar St , Shahid Gheybi Square, Ray Tehran.
City
Rey
Province
Tehran
Postal code
1843893744
Phone
+98 21 5595 1581
Email
zeynablashani@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 the obtained data, except the identification information of the people, will be presented in the review of the individual subjects and their results.
When the data will become available and for how long
The access period will start in the second half of 1402.
To whom data/document is available
for everyone
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Theses center is located in the library of Shahid University
What processes are involved for a request to access data/document
It is possible by presenting a student card or a research certificate to the library of Shahid University during office hours.
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