The research will be conducted with the aim of investigating the effectiveness of Unified Transdiagnostic treatment on the excitability and emotional regulation of children with DMDD
Design
Clinical trial with control group, random assignment on 30 patients. A simple random method was used for randomization.
Settings and conduct
The intervention was carried out at Ravan Yar Psychological Counseling and Services Center in Shiraz. First, the purpose, implementation method and lack of coercion to participate in the research were explained to the subjects and their mothers, and the agreements to participate in the research were confirmed through the consent form. The intervention plan of the research was an unified transdiagnostic course (Ehrenreich-May & Bilek, 2012) that was implemented in 15 two-hour sessions and over 15 weeks for children and their mothers.
Participants/Inclusion and exclusion criteria
Entry requirements:
Not having other psychiatric and neurological disorders, cognitive disability, ascertaining the definite diagnosis of the disorder, age range of 9 to 12 years, not using medicine during the research period and a consent letter stating their agreement to participate in the research.
Intervention groups
30 children (15 in the experimental group and 15 in the control group) who received a definitive diagnosis of DMDD based on multidimensional structured diagnostic interview assessments based on DSM5 criteria by an independent psychiatrist and psychologist.
Main outcome variables
emotion self-regulation and irritability of children with DMDD
General information
Reason for update
Acronym
UTDMDD
IRCT registration information
IRCT registration number:IRCT20180512039620N1
Registration date:2022-09-26, 1401/07/04
Registration timing:retrospective
Last update:2022-09-26, 1401/07/04
Update count:0
Registration date
2022-09-26, 1401/07/04
Registrant information
Name
Mohamad Mehdi Hasanshahi
Name of organization / entity
Tَhe University of Arsanjan
Country
Iran (Islamic Republic of)
Phone
+98 71 3648 6971
Email address
hassanshahi_mehdi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-06-19, 1400/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of unified transdiagnostic group therapy on emotion self-regulation and irritability of children with DMDD
Public title
The effectiveness of unified transdiagnostic group therapy on DMDD
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
not having other psychiatric and neurological disorders
Not using medicine during the research period
age range 9 to 12 years
Not using medicine during the research period
Consent letter stating their agreement to participate in the research
Exclusion criteria:
having other psychiatric and neurological disorders
Use of medicine during the research period
Lack of consent to participate in the research
cognitive disability,
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The studied sample included 30 children (15 in the experimental group and 15 in the control group) of children who received a definitive diagnosis of disruptive mood disorder based on the multidimensional evaluations of the structured diagnostic interview based on DSM5 by an independent psychiatrist and psychologist. They were assigned to experimental and control groups in equal proportion by random assignment method. It is worth mentioning that the studied groups were matched in terms of education level and gender
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The studied sample included 30 children (15 in the experimental group and 15 in the control group) of children who received a definitive diagnosis of DMDD based on the multidimensional evaluations of the structured diagnostic interview based on DSM5 by an independent psychiatrist and psychologist. They were randomly assigned to experimental and control groups in equal proportions.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arsanjan Islamic Azad University
Street address
University Boulevard - Department of Psychology
City
Arsanjan
Province
Fars
Postal code
۷۳۷۶۱۵۳۱۶۱
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.IAU.A.REC.1400.011
Health conditions studied
1
Description of health condition studied
Disruptive mood dysregulation disorder (DMDD)
ICD-10 code
F34.81
ICD-10 code description
Disruptive mood dysregulation disorder
Primary outcomes
1
Description
emotion self-regulation and irritability
Timepoint
Three rounds of pre-exam, post-exam and follow-up exam (3 months)
Method of measurement
Shields and Cicchetti's Emotional Regulation Checklist (1995)The affective reactivity index (Stringaris et al., 2012)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention plan of the research is a unified transdiagnostic treatment course that is implemented in 15 two-hour sessions for 15 weeks for children and their mothers. In this research, the unified transdiagnostic treatment protocol for children's emotional disorders, which was first implemented by Ehrenreich-May and Bilek (2012) on a group of 9-12-year-old children with emotional disorders and their parents, is used.
Category
Behavior
2
Description
Control group: The control group does not receive any treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Farnam's Psychiatry Office RavanYar Psychological and Counseling and Services Center
Full name of responsible person
Dr Rabert Farnam
Street address
No. 4, Shahid Faqihi Ave., Zand Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7184763424
Phone
+98 71 3233 4344
Email
rabertfarnam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
ِDr Saeed Mohtasham
Street address
No. 1, Daneshgah Blvd., Arsanjan city
City
Arsanjan
Province
Fars
Postal code
۷۳۷۶۱۵۳۱۶۱
Phone
+98 71 4352 2482
Email
s_mohtasham@iaua.ac.ir
Web page address
https://arsanjan.iau.ir
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
Private
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
Mohamad Mehdi hasanshahi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 7, Namazi Ave., Satarkhan Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7184763424
Phone
+98 71 8476 3424
Email
mmehdihassanshahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohamad Mehdi Hasanshahi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 7, Namazi Ave., Satarkhan Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7184763424
Phone
+98 71 3648 6971
Email
m_hassanshahi@iaua.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohamad Mehdi Hasanshahi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 7, Namazi Ave., Satarkhan Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7184763424
Phone
+98 71 3948 6971
Email
hassanshahi_mehdi@yahoo.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
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
1 year after publication
To whom data/document is available
Researchers of academic and scientific institutions
Under which criteria data/document could be used
The data will be available only to researchers working in academic and scientific institutions
From where data/document is obtainable
-Vice President of Research, Arsanjan Islamic Azad University
Fars Province, Arsanjan, University Blvd. Postal code: 7376153161 PO Box: 168-73761
What processes are involved for a request to access data/document
Sending the application along with the confirmation of the university of the place of service - the purpose of using the data - the picture of scientific confirmations. Examining the application in the educational department of the university - providing an answer to the applicant