The effectiveness of Unified Transdiagnostic Treatment on the symptoms of emotional disorders and emotion regulation of parents and improvement of behavioral problem in 3-6 years old hard of hearing children
Investigating the effectiveness of integrative transdiagnostic treatment on the symptoms of emotional disorders and emotional regulation of parents and behavioral problems of hearing-impaired children aged 3-6
Design
The clinical trial has a control group with parallel groups,randomized using a table of random numbers on 30 people.
Settings and conduct
In this study, parents of hearing impaired children aged 3 to 6 years who have symptoms of emotional disorders and at the same time their children have behavioral problems participate. This study is conducted in the form of twelve group therapy sessions, one hour each session in virtual space. The researcher implements the treatment course. This approach uses emotional exposure and emotional awareness and increasing the emotional tolerance capacity in the form of exercises. Blinding is not done.
Participants/Inclusion and exclusion criteria
Parent entry criteria
- A parent with symptoms of emotional disorders
- Hearing
- Being a Persian speaker
- Minimum diploma education
Criteria for exiting people to research:
- Acute behavioral and psychological problems that the researcher suspects during the sessions or after the questionnaires.
- Failure to attend more than two sessions
Intervention groups
The intervention group of the metadiagnostic integrated protocol is held in twelve sessions, which work on the emotional exposure and excitement of awareness and increasing the capacity to tolerate emotions.
The control group received usual services.
Main outcome variables
the symptoms of emotional disorders; parental emotion regulation; the behavioral problems of hearing-impaired children aged 3-6
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230124057202N1
Registration date:2023-03-27, 1402/01/07
Registration timing:prospective
Last update:2023-03-27, 1402/01/07
Update count:0
Registration date
2023-03-27, 1402/01/07
Registrant information
Name
mahsa khakpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3722 9293
Email address
khakpourmahsa76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Unified Transdiagnostic Treatment on the symptoms of emotional disorders and emotion regulation of parents and improvement of behavioral problem in 3-6 years old hard of hearing children
Public title
The effectiveness of Unified Transdiagnostic Treatment on the symptoms of emotional disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All parents with a deaf child over the age of three
Parent's willingness
The parent has symptoms of emotional disorder
Minimum education is diploma
Being a Persian speaker
Exclusion criteria:
Acute behavioral and psychological problems that the researcher suspects during the sessions or after the questionnaires.
Absent more than two sessions
Age
No age limit
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
In this study, people are randomly assigned to one of the two study groups using a table of random numbers. The randomization method is simple. The randomization unit is individual.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of social welfare and rehabilitation of tehran
Street address
University of Rehabilitation Sciences and Social Health, Tehran, Evin, Dargheh Blvd
City
tehran
Province
Tehran
Postal code
1985713834
Approval date
2023-01-18, 1401/10/28
Ethics committee reference number
IR.USWR.REC.1401.218
Health conditions studied
1
Description of health condition studied
emotional disorders
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in Beck's questionnaire
Timepoint
Beck questionnaire anxiety score at the beginning of the study and 4 weeks, 8 weeks, 12 weeks and 3 months after the end of the intervention
Method of measurement
Beck's anxiety questionnaire
Secondary outcomes
1
Description
Emotion regulation score in Gertz and Romer emotion regulation difficulty questionnaire
Timepoint
Emotion regulation score in the emotion regulation difficulty questionnaire at the beginning of the study and 4 weeks, 8 weeks, 12 weeks and 3 months after the end of the intervention.
Method of measurement
Gratz and Roemer Difficulties in Emotion Regulation Scale
2
Description
Beck questionnaire depression score
Timepoint
Beck questionnaire depression score at the beginning of the study and 4 weeks, 8 weeks, 12 weeks and 3 months after the end of the intervention
Method of measurement
Beck depression questionnaire
3
Description
Children's Behavioral Problems Score of Eyberg Questionnaire
Timepoint
The score of children's behavioral problems in the Ayberg questionnaire at the beginning of the study and 4 weeks, 8 weeks, 12 weeks and 3 months after the end of the intervention
Method of measurement
Eyberg Behavioral Problems Questionnaire
Intervention groups
1
Description
Intervention group: The intervention with an integrative meta-diagnostic approach consists of twelve group therapy sessions in the form of a one-hour session per week. which takes place on the Internet. Currently, the protocol of the integrative metadiagnostic approach consists of eight parts. The first part is increasing motivation, the second part is the adaptive nature of emotions and the main components of emotional experience, the third part is emotional awareness training, the fourth part is cognitive reevaluation, the fifth part is behaviors caused by excitement and emotional avoidance, the sixth part is awareness and tolerance of physical feelings, the seventh part is exposure. internal and situational and the eighth section is to prevent recurrence. The researcher has completed the training course related to the approach and organizes the meetings.
Category
Treatment - Other
2
Description
Control group: No intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
parvanr ha group
Full name of responsible person
gita movaleli
Street address
University of Rehabilitation Sciences and Social Health, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 915 987 7174
Email
khakpourmahsa76@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
kianosh abdi
Street address
University of Rehabilitation Sciences and Social Health, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
webmaster@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
Mahsa Khakpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Esfarayen. taleghani3،negar5،12
City
Tehran
Province
Tehran
Postal code
9661873618
Phone
+98 58 3722 9293
Fax
Email
khakpourmahsa76@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Neda alibeigi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Welfare and Rehabilitation Sciences, Student Blvd.
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 3340 1604
Email
nedapsych@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mahsa Khakpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Esfarayen. taleghani3،negar5،12
City
Tehran
Province
Tehran
Postal code
9661873618
Phone
+98 58 3722 9293
Fax
Email
khakpourmahsa76@gmail.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
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