Determining the effect of Cognitive-Behavioral Interventions on Domestic Violence and its Consequences in Transgender People.
Design
Randomized clinical trial with parallel groups
Settings and conduct
The sampling site is the Tehran Gender Dysphoria Association, where 50 transgenders are selected from their list. DASS-21, and Rosenberg self-esteem questionnaires will be completed by transgenders and the CTSP questionnaires by their guardian, and self report domestic violence cheklist will be given to transgenders .The guardians of transgender people are divided into two groups.The guardian of 25 transgender persons will be in intervention group A and the other 25 in the intervention group B.Cognitive-behavioral interventions will be sent in 8 one-hour in-person sessions to group A and via telegram to group B.The questionnaires will be completed again 2 months after the sessions.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Defenitive diagnosis of Gender dysphoria by Psychiatrist of Forensic Medicine,
Living in a home with parents or guardians,
Trangender's and his/her parents or guardian's Willingness to participate in the study,
Age over 12 years,
Being the victiom of domestic violence;
Exclusion Criteria:
Suffering of Congenital Adrenal Hyperplasia,
Suffering of Androgen Insensitivity Syndrome,
Living apart from parents or guardians,
The transgender's and his/her parents or guardian's unwillingness to participate in the study
Intervention groups
cognitive-behavioral interventions will be performed on parents or guardian's of transgenders. These trainings will be given to the intervention group A by lecture method and to the intervention group B via telegram channel.
Main outcome variables
The main outcome of this study is domestic violence, which means physical, psychological, verbal, and sexual violence perpetrated by a transexual parent or guardian.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120609009975N7
Registration date:2020-03-08, 1398/12/18
Registration timing:registered_while_recruiting
Last update:2020-03-08, 1398/12/18
Update count:1
Registration date
2020-03-08, 1398/12/18
Registrant information
Name
Farnaz Farnam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4217
Email address
fz.farnam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Cognitive -behavioral interventions on Domestic Violence and its Consequences in Transgender people
Public title
Effects of Cognitive -behavioral interventions on Domestic Violence and its Consequences
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Defenitive diagnosis of Gender dysphoria by Psychiatrist of Forensic Medicine
Living in a home with parents or guardians
Transgender person's Willingness to participate in the study
Parent's or guardian's of Trangender willingness to participate in the study
Age over 12 years
Being a victim of domestic violence
Exclusion criteria:
Suffering of Congenital Adrenal Hyperplasia
Suffering of Androgen Insensitivity Syndrome
Living apart from parents or guardians
The transgender person's unwillingness to participate in the study
Parent's or guardian's of Transgender unwillingness to participate in the study
Age
From 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
1
For each transgender person participating in the study, at least one parent or guardian of the individual will be included in the study for cognitive behavioral intervention.Open in Google Translate
Randomization (investigator's opinion)
Randomized
Randomization description
First, from the list of transexual people in the Gender dysphoria Society 50 people who meet the inclusion criteria is selected. The subjects were then randomly divided into two groups of intervention A and intervention B using random blocking of four blocks size .There are 6 modes for blocks, including: TTCC, TCTC, TCCT, CCTT, CTTC, and CTTC for random allocation by blocking and assigning subjects to 2 intervention (T) and control (C) groups. By using the computer we create random numbers; For numbers 0 to 1/6, Compound 1 (CTTC), For numbers 1/6 to 2/6 , compound 2 (CCTT), for numbers 2/6 to 3/6 , compound 3 (TCCT), for numbers 3/6 to 4/6 compound 4 (TCTC), for numbers 4/6 to 5/6 Compound 5 (CTTC) and for numbers 5/6 to 6/6 Compound 6 (TTCC) will be used.
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
School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Sciences
Street address
Tohid square, Dr.Mirkhani street, school of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-02-18, 1398/11/29
Ethics committee reference number
IR.TUMS.FNM.REC.1398.201
Health conditions studied
1
Description of health condition studied
Gender Dysphoria
ICD-10 code
F64.9
ICD-10 code description
Gender identity disorder, unspecified
2
Description of health condition studied
Domestic Violence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Domestic violence
Timepoint
Before intervention, 2 months after the end of the intervention
Method of measurement
Self Report of Domestic Violence Checklist
Secondary outcomes
1
Description
Depression
Timepoint
Before intervention , 2 months after the end of the intervention
Method of measurement
Depression- Anxiety- Stress Scale (DASS-21)
2
Description
Anxiety
Timepoint
Before intervention , 2 months after the end of the intervention
Method of measurement
Depression- Anxiety- Stress Scale (DASS-21)
3
Description
Stress
Timepoint
Before intervention , 2 months after the end of the intervention
Method of measurement
Depression- Anxiety- Stress Scale (DASS-21)
4
Description
Self-esteem
Timepoint
Before intervention , 2 months after the end of the intervention
Method of measurement
Rosenberg Self-esteem Questionnaire
5
Description
High-risk behaviors
Timepoint
Before intervention , 2 months after the end of the intervention
Method of measurement
High-risk behaviors questions of demographic questionnaire
6
Description
parents's conflict tactics
Timepoint
Before intervention , 2 months after the end of the intervention
Method of measurement
Conflict tactics scale parents (CTSP)
Intervention groups
1
Description
Intervention group A: They will subjected to 8 one-hour in-person sessions (if parents do not attend: 4 two-hour sessions) cognitive-behavioral intervention. The first two sessions included information on changing parents' Cognitive of gender dysphoria and violence, and next sessions included training to change violent behavior, anger and calm control, speech skills training, empathy skills, conversation skills, resolution skills, emotion control, stress management.
Category
Behavior
2
Description
Intervention group B:For these people , cognitive-behavioral interventions that include information to change parents' perceptions of gender dysphoria and violence, and training to change violent behavior, anger and calm control, speech skills training, empathy skills, conversation skills, , Conflict resolution, emotion control, stress-management, Will be sent in 8 one-hour voices.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Gender Dysphoria Association
Full name of responsible person
Farnaz Farnam
Street address
Tohid Square, Dr.Mirkhani St, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
f_farnam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Science
Full name of responsible person
Mohammad Ali Sahraian
Street address
Tohid Square، Nosrat st,Tehran, Reproductive Health Department, Tehran University of Medical sciences
City
Tehran
Province
Tehran
Postal code
1419733181
Phone
+98 21 6105 4000
Email
mahdieh.d20@gmail.com
Web page address
http://fnm.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of Medical Science
Proportion provided by this source
50
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
Tehran University of Medical Sciences
Full name of responsible person
Mahdieh Damanpak
Position
Master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr.Mirkhani St, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
mahdieh.d20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnaz Farnam
Position
Assistant Professor in Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tohid Square, Dr. Mirkhani St, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
f_farnam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdieh Damanpak
Position
Master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani Street, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
mahdieh.d20@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We're going to publish the results and not distribute the data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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