Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00646

2 Trial Registration Date

2018-12-17

i Registration Status

Prospective

3 Secondary IDs

2018.488-T

4 Source(s) of Funding

NIL

5 Primary Sponsor

NIL

6 Secondary Sponsor

NIL

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Sin Ling Yum Natalie

ii Address

Department of Psychology, Prince of Wales Hospital, Hospital Authority

iii Phone

35052505

iv Email

sly252@ha.org.hk

v Affiliation

Department of Clinical Psychology, Prince of Wales Hospital

vi Country

Hong Kong, China

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Ling Yum Natalie Sin

ii Address

Department of Psychology, Prince of Wales Hospital, Hospital Authority

iii Phone

64702361

iv Email

natalie.sin@gmail.com

v Affiliation

Department of Clinical Psychology, Prince of Wales Hospital, Hospital Authority

vi Country

Hong Kong

9 Official Scientific Title of the Study

Psychological Adjustment of Transgender Individuals in Hong Kong: An Intervention Study

10 Public Title

Psychological Adjustment of Transgender Individuals in Hong Kong: An Intervention Study

i Public Title in Chinese 研究名稱

跨性別人士的心理健康: 有關介入方式的研究

11 Short Title (Optional)

Psychological Intervention for HK Transgender Individuals

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-12-07

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.488-T

14 Medical Condition Being Studied

Transgender

Transsexual

Gender identity disorder

Gender Incongruence

15 Intervention

i Types of intervention

Other

Please specify

Psychological Intervention Group

ii Description/ name of Intervention/article

Two Components of the Psychological Intervention Group
- One session of Psychoeducation to provide factual information and knowledge for the families of transgender patients

- One session of training on effective communication skills to improve the communication and interaction style between family members and transgender patients.

On top of the intervention group, the participants will still continue to attend their usual individual sessions (i.e., same as control group).

iii Dosage form of the intervention

The intervention will be delivered in form of groups with 8-20 participants (depending on participants' availability).

iv Dosage of the intervention

N/A

v Duration of the intervention

Each session is estimated to be within 2 hours

vi Frequency of the intervention

The second session will be completed within 1 week after the first session.

16 Comparative Treatments

i Description/ name of comparative treatments

Control (Treatment As Usual).

- Participants in this group will continue with their usual service at the Gender Identity Disorder Clinic--they will continue to attend their sessions alone, as usual.

ii Dosage form of the comparative treatments

Individual assessment / intervention (without parents' attendance).

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

Each session is estimated to be within 45 minutes

v Frequency of the comparative treatments

Around once every 2~3 months.

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Experiences symptoms of gender dysphoria

Attends The Gender Identity Disorder Clinic at the Prince of Wales Hospital

18 Years of age

Patient and the parent both being fluent in Cantonese and/or being literate in Chinese

ii Exclusion Criteria

Significant intellectual and/or communication deficits

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Not a drug trial

vi Study Objectives (Optional)

To investigate the benefits of intervention involving family members of transgender individuals in Hong Kong.

20 Anticipated trial start date

2019-01-01

21 Target Sample Size

50 patients [+50 of their relevant family member(s)]

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Psychological Adjustment (transgender patients only)

ii The metric or method of measurement used

Questionnnaire (Depression, Anxiety, and Stress Scale)

iii The timepoint(s) of primary interest

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

Primary Outcome

i The Name of the outcome

Communication Skills (Both family & transgender patients)

ii The metric or method of measurement used

Questionnaire (Coping Strategies in Chinese Social Context Scale)

iii The timepoint(s) of primary interest

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

Primary Outcome

i The Name of the outcome

Transphobic attitude (Family of transgender patients only)

ii The metric or method of measurement used

Questionnaire (Genderism and Transphobia Scale)

iii The timepoint(s) of primary interest

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

Primary Outcome

i The Name of the outcome

Perceived Family Support (transgender patient only)

ii The metric or method of measurement used

Questionnnaire (Multi-dimensional Scale of Perceived Social Support )

iii The timepoint(s) of primary interest

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

24 Secondary Outcome

i The Name of the outcome

Psychological Adjustment (transgender patients only)

ii The metric or method of measurement used

Questionnaire (Transgender Congruence Scale)

iii The timepoint(s) of primary interest

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

Secondary Outcome

i The Name of the outcome

Psychological Adjustment (transgender patients only)

ii The metric or method of measurement used

Questionnaire (Gender Congruence and Life Satisfaction Scale)

iii The timepoint(s) of primary interest

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-08-13

27 Primary Registry and Trial Identifying Number

ChiCTR1900021042

28 Date of Registration in Primary Registry

2018-12-18

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Trial History Detail on 2019-01-29