The efficacy of group therapy based on affect regulation training, drug therapy, and combination of affect regulation training with drug therapy in reducing adolescent conduct disorder symptoms
-Determining the effect of group therapy based on ART in reducing the number of conduct disorder symptoms.
-Determining the effect of group therapy based on ART in reducing the severity of symptoms.
- Determining the effect of drug treatment in reducing the number of symptoms.
-Determining the effect of drug treatment in reducing the severity of symptoms.
- Determining the effect of ART with drug treatment in reducing the number of symptoms.
- Determining the effect of ART with drug treatment in reducing the severity of symptoms.
Design
A controlled, parallel-group, single-blind, non-randomized, phase 1-2 clinical trial on 36 patients.
Settings and conduct
The method of conducting the present research will be that first, the patients present in the clinic of Razi Medical Education Center in Tabriz will be clinically interviewed by a psychiatrist, and after receiving the diagnosis of behavioral disorder, they will undergo additional evaluations by a psychologist based on the Achenbach scale and ask questions related to The entry and exit criteria are checked. After the test, the evaluator checks the severity of symptoms and does not know the subject's group membership.
Participants/Inclusion and exclusion criteria
Referrals for treatment
16-18 years old
Suffering from conduct disorder based on DSM-5 diagnostic criteria
Not using any drugs for at least 3 weeks
Not using any psychiatric medication two weeks before the treatment
Male gender
Intervention groups
Experimental group with ART
Drug test group
Experimental group with drug and ART combination
the first experimental group received affect regulation training, the second experimental group received drug therapy, and the third group received the combination of ART with drug therapy. The treatment course lasts for three weeks.
Main outcome variables
Number of conduct disorder symptoms
Severity of conduct disorder symptoms
General information
Reason for update
Acronym
ART
IRCT registration information
IRCT registration number:IRCT20091103002660N5
Registration date:2022-08-20, 1401/05/29
Registration timing:prospective
Last update:2022-08-20, 1401/05/29
Update count:0
Registration date
2022-08-20, 1401/05/29
Registrant information
Name
Shahrokh Amiri Aziza Abad
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1380 4486
Email address
amirish@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of group therapy based on affect regulation training, drug therapy, and combination of affect regulation training with drug therapy in reducing adolescent conduct disorder symptoms
Public title
The efficacy of group therapy in reducing adolescent conduct disorder symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Referrals for treatment
Being at least 16 years old and at most 18 years old
Suffering from conduct disorder based on DSM-5(Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria
Not using any drugs for at least 3 weeks
Not using any psychiatric medication during two weeks before the treatment
male gender
Exclusion criteria:
Suffering from severe psychiatric diseases other than Oppositional defiant Disorder and Attention deficit hyperactivity disorder
Inability to read and write or having any problem that makes the person unable to respond to listening or writing assignments related to psychological treatments.
Age
From 16 years old to 18 years old
Gender
Male
Phase
1-2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In all stages, the evaluator, consisting of a psychologist and a psychiatrist, is unaware of the subjects' group membership and will not be aware of which subjects have been affected by which type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
El-Goli Road, Razi Medical Education Center, research center of Psychiatry and Behavioral Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Approval date
2022-08-01, 1401/05/10
Ethics committee reference number
IR.TBZMED.REC.1401.377
Health conditions studied
1
Description of health condition studied
conduct disorder
ICD-10 code
F91
ICD-10 code description
اختلال سلوک
Primary outcomes
1
Description
number of symptoms
Timepoint
Immediately after receiving the intervention and two months later
Method of measurement
Achenbach questionnaire
2
Description
severity of symptoms
Timepoint
Immediately after receiving the intervention and two months later
Method of measurement
Achenbach questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: experimental group with affect regulation training
Category
Treatment - Drugs
2
Description
Intervention group: Experimental group with drugs
Category
Treatment - Drugs
3
Description
Intervention group: Experimental group with combination of affect regulation training and drugs
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital of Tabriz
Full name of responsible person
prof.shahrokh amiri
Street address
Elgoli road
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3382 6512
Email
sh_amiri1348@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
prof.Ali fakhari
Street address
El-goli road
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3382 6512
Email
a_fakhari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical 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
Tabriz University of Medical Sciences
Full name of responsible person
Shahrokh Amiri Aziza Abad
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Razi Psychiatric Hospital, El Goli Boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 1380 4486
Fax
+98 41 1380 3351
Email
amirish@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shahrokh Amiri Aziza Abad
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Razi Psychiatric Hospital, El Goli Boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 1380 4486
Fax
+98 41 1380 3351
Email
amirish@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
zahra bakhtshokuhi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Razi Psychiatric Hospital, El Goli Boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 1380 4486
Fax
+98 41 1380 3351
Email
bakhtshokuhi@gmail.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
Yes - There is 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 printed article from the research will be available to the patients and their families.
When the data will become available and for how long
After the completion of the research and six months after the publication of the results
To whom data/document is available
The patient and the patient's family
Under which criteria data/document could be used
To raise awareness about the nature of the disorder and available treatments
From where data/document is obtainable
Research Center of Psychiatry and Behavioral Sciences,Tabriz University of Medical Sciences and project manager
What processes are involved for a request to access data/document
Visiting the project manager in person and calling or emailing to exchange information is defined.