Protocol summary
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Study aim
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Determining the effect of Cognitive-Behavioral Interventions on family Violence and its Consequences in Transgender People.
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Design
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Randomized clinical trial with parallel groups
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Settings and conduct
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50 transgender people with inclusion criteria will be selected via the Internet (Twitter and Instagram). DASS-21, and Rosenberg self-esteem questionnaires will be completed by transgenders and the CTSP questionnaires by their parents, and self report family violence checklist will be given to transgenders to complete for 30 days. The transgender people will be divided into two groups. Cognitive-behavioral interventions will be sent in 8 one-hour online sessions to parents of intervention group. Immediately after the education sessions, the CTSP questionnaire will be completed by the parents. 2 months after the end of the cognitive-behavioral sessions, other questionnaires will be given to transgender people again.
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Participants/Inclusion and exclusion criteria
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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 family violence;
Exclusion Criteria:
The transgender's and his/her parents or guardian's unwillingness to participate in the study
absence in more than 1 education session
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Intervention groups
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cognitive-behavioral interventions will be performed on parents or guardian's of transgenders. These training sessions will be held via internet for the parents of the intervention group.
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Main outcome variables
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The main outcome of this study is family violence, which means physical, psychological, verbal, and sexual violence perpetrated by a transgender's parent or guardian.
General information
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Reason for update
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1-we found that the researcher-made questionnaire was not suitable for measuring family violence against transgender people, so the method of measuring the family violence variable was changed to a daily checklist for measuring violence completed by a transgender for 30 days.
2-Also, since sampling has not started yet, the sampling date was changed.
3- Due to the prevalence of Covid-19 virus, training sessions will be held online, so the sample people will be divided into 2 intervention groups (who receive online training sessions) and a control group.
4-In addition to the Iranian Gender dysphoria Association, sampling will also include transgender support pages on Instagram and Twitter.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120609009975N7
Registration date:
2020-03-08, 1398/12/18
Registration timing:
prospective
Last update:
2021-01-03, 1399/10/14
Update count:
1
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Registration date
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2020-03-08, 1398/12/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-03-01, 1399/12/11
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Expected recruitment end date
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2021-06-01, 1400/03/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of Cognitive -behavioral interventions on ّFamily violence and its Consequences in Transgender people
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Public title
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Effects of Cognitive -behavioral interventions on Family Violence and its Consequences
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Defenitive diagnosis of Gender dysphoria
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 family violence
Exclusion criteria:
The transgender person's unwillingness to participate in the study
Parent's or guardian's of Transgender unwillingness to participate in the study
Absence in more than 1 training session
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Age
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From 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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We will study 50 transgender youth, who will gather from the list of trangender people of the Gender dysphoria association and through Internet. An announcement about this study will first be posted on the Transgender support pages in Instagram and Twitter. The subjects will then randomly divided into intervention and control group by using random block size of four .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 1, Compound 1 (CTTC), For numbers 2 , compound 2 (CCTT), for numbers 3 , compound 3 (TCCT), for numbers 4 compound 4 (TCTC), for numbers5 Compound 5 (CTTC) and for numbers 6 Compound 6 (TTCC) will be used.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-18, 1398/11/29
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Ethics committee reference number
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IR.TUMS.FNM.REC.1398.201
Health conditions studied
1
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Description of health condition studied
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Gender Dysphoria
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ICD-10 code
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F64.9
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ICD-10 code description
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Gender identity disorder, unspecified
2
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Description of health condition studied
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family Violence
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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family violence
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Timepoint
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Before intervention, 2 months after the end of the intervention
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Method of measurement
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Self Report of family violence checklist
2
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Description
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Depression
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Timepoint
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Before intervention , 2 months after the end of the intervention
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Method of measurement
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Depression- Anxiety- Stress Scale (DASS-21)
3
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Description
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Anxiety
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Timepoint
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Before intervention , 2 months after the end of the intervention
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Method of measurement
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Depression- Anxiety- Stress Scale (DASS-21)
4
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Description
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Stress
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Timepoint
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Before intervention , 2 months after the end of the intervention
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Method of measurement
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Depression- Anxiety- Stress Scale (DASS-21)
5
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Description
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Self-esteem
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Timepoint
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Before intervention , 2 months after the end of the intervention
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Method of measurement
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Rosenberg Self-esteem Questionnaire
Secondary outcomes
1
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Description
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parents's conflict tactics
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Timepoint
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Before intervention ,immediately after the intervention
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Method of measurement
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Conflict tactics scale parents (CTSP)
2
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Description
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High-risk behaviors
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Timepoint
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Before intervention , 2 months after the end of the intervention
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Method of measurement
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High-risk behaviors questions of demographic questionnaire
Intervention groups
1
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Description
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Intervention group : They will be subjected to 8 one-hour online 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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for research of Tehran University of Medical Science
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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We're going to publish the results and not distribute the data
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available