Effectiveness of unified protocol for transdiagnostic treatment on improving psychopathological symptoms and quality of life in children with emotional disorders
Effectiveness of unified protocol for transdiagnostic treatment on improving psychopathological symptoms and quality of life in children with emotional disorders
Design
Clinical trial with control group, with parallel group, one-sided blind with randomized group
Settings and conduct
Treatment is individual or group and with the presence of one or both parents. Children are encouraged to learn the skills of this protocol, which are developed and organized around the identification of emotions and awareness of thoughts and emotions and the experience of emotions to solve the puzzle of their emotions. The place of study is the first and second elementary schools of Kermanshah city.
Participants/Inclusion and exclusion criteria
Include Criteria; Age group 8 to 13 years. Early diagnosis of anxiety disorders or depression. Consent of the child and the parent(s)
Exclude Criteria:
Intervention groups
The intervention group receives 15 weekly sessions of individual 50-minute treatment, in schools and by a trained therapist. The presence of one or both parents in the treatment process is mandatory. Assessments will be performed before the intervention, after the intervention and 2 months after the intervention. The control group receives psychological training. Psychological training, relaxation techniques are provided to reduce the level of stress and stress. The control group will receive integrated meta-diagnostic therapy (UP_C) after the end of the study.
Main outcome variables
Revised Child Anxiety and Depression Scale(RCADS)
Pediatric Quality of Life Inventory
Achenbach Behavior Inventory Score (CBCL)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180421039369N5
Registration date:2021-01-11, 1399/10/22
Registration timing:registered_while_recruiting
Last update:2021-01-11, 1399/10/22
Update count:0
Registration date
2021-01-11, 1399/10/22
Registrant information
Name
Nasrin Jaberghaderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 4622
Email address
nasrin.jaberghaderi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of unified protocol for transdiagnostic treatment on improving psychopathological symptoms and quality of life in children with emotional disorders
Public title
Effectiveness of unified protocol for transdiagnostic treatment on improving psychopathological symptoms and quality of life in children with emotional disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of primary diagnosis of anxiety disorders or depression
Consent of the child and the parent(s) to participate in the treatment and research process
Age 8 to 13 years
Ability of parents and children to read, write and speak Persian
Exclusion criteria:
Recurrence of psychological sign and symptoms before the start of the treatment process and after sampling
Simultaneous infection with another disease
Therapy with medicine or ECT
Age
From 8 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the samples based on entry criteria, the random sample of the samples is sampled in a sealed envelope. Ultimately, people are assigned to the control and test group
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will only happen for the statistical analyst and data collector. In this way, after the assessment and disease, the sample is entered into the study and for each assessment or evaluation by another person who is not in the process of treatment and study. Information and data also will be coded and given to the statistical analyst for any necessary measurements without any personal details.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
In front of Taleghani Hospital, Naft square
City
Kermanshah
Province
Kermanshah
Postal code
56423-22222
Approval date
2020-11-04, 1399/08/14
Ethics committee reference number
IR.KUMS.REC.1399.814
Health conditions studied
1
Description of health condition studied
Emotional disorders in childeren
ICD-10 code
F93
ICD-10 code description
Emotional disorders with onset specific to childhood
Primary outcomes
1
Description
Children's Anxiety and Depression score
Timepoint
pre-test, post-test, follow-up
Method of measurement
Revised Children's Anxiety and Depression Scale
2
Description
children's quality of life score
Timepoint
pre-test, post-test, follow-up
Method of measurement
Children's Quality of Life Questionnaire
3
Description
Child Behavior Checklis -Akhenbakh
Timepoint
pre-test, post-test, follow-up
Method of measurement
Child Behavior Checklist of scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Experimental or intervention group, treatment plan will be done in 15 sessions of individual therapy (50 minutes per session) by the researcher and psychotherapist who has received the necessary training in the implementation of this treatment.The presence of one or both parents in the treatment process is mandatory.
Category
Rehabilitation
2
Description
Control group: The number of members of the control group is 15 people. Participants are trained during the treatment sessions of the experimental group. These trainings make children and their parents aware of the nature of the problems they are involved in, if necessary and in case of aggravation of symptoms, along with psychological trainings, relaxation techniques to reduce the level of stress and psychological stress. Members of the control group will receive integrated meta-diagnostic therapy (UP_C) after the end of the study.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Education of Kermanshah Province
Full name of responsible person
Nasrin JaberGhaderi
Street address
Department of Education of Kermanshah province,Farhangian1 Blv, Shahid Mostafa Emami Avenu, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
49564-39936
Phone
+98 83 3822 6451
Email
Pardis.jm7374@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Kermanshah University of Medical Science, Sepah Square,Shahid Beheshti Blv, Kermanshah,Iran.
City
Kermanshah
Province
Kermanshah
Postal code
4562388887
Phone
+98 83 3838 4180
Email
pardis.jm7374@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Pardis Jamshid Mofid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Medical, Sorkhe lize Ave, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
8614733481
Phone
0918723036
Email
pardis.jm7374@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin JaberGhaderi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Medical School, Kermanshah University of Medical Sciences, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671451568
Phone
+98 83 3887 4371
Email
n_jg2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin JaberGhaderi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Medical School, Kermanshah University of Medical Sciences, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671451568
Phone
+98 83 3887 4371
Email
n_jg2004@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available