Evaluation of Trans Adolescent Group ThErapy for Alleviating Minority Stress (TAG TEAM): a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Changes in level of psychological distress measured using the total score from the Depression Anxiety Stress Scales - Youth version (DASS-Y)
研究概览
简要总结
This project will study the effect of the TAG TEAM group CBT program on the mental health of trans and gender diverse adolescents. TAG TEAM was co-designed by researchers and clinicians with a group of trans and gender diverse young people to help trans and gender diverse adolescents understand and cope with minority stress. Minority stress includes experiences like discrimination and rejection. TAG TEAM focuses on learning and practicing skills to support mental health and wellbeing. It also includes group discussions and activities with other trans and gender diverse young people. TAG TEAM groups are run by a psychologist and a trans peer facilitator. A trans peer facilitator is a trans and gender diverse person who is there to share their experience of being trans and to support participants in the group sessions.
详细描述
Trans Adolescent Group ThErapy for Alleviating Minority stress (TAG TEAM), is a group Cognitive Behavioural Therapy (CBT) program, originally developed using co-design methodology with trans and gender diverse young people. The 6 weekly, 2-hour session TAG TEAM program aims to improve mental health and wellbeing using evidence-based cognitive and behavioural strategies.
The intervention is a group CBT program, with sessions being split into distinct themes relating to minority stress and protective factors against such stress (i.e., community connectedness, discrimination and rejection, internalised stigma, and pride) and is based on core CBT principles (e.g., assigning and reviewing between-session activities, learning and practicing techniques). The sessions will include videos of trans and gender diverse adults discussing the session themes. Each session includes a 10-minute break halfway through the session.
The randomised controlled trial (RCT) will be a two-arm parallel group superiority trial where participants are randomised in a 1:1 ratio to an intervention or waitlist control arm. A mixed method design will involve quantitative analyses to evaluate the effectiveness of the intervention compared to the waitlist control.
There will also be a qualitative sub-study where participants will participate in photovoice or semi-structured interviews to evaluate their experience of the intervention. The investigators will use photovoice to investigate participants' experiences of the group CBT program and their views and perspectives on how the intervention affected their behaviour and mental health. Photovoice is a qualitative research method where participants are asked to take photos that respond to the study aims, and are then given the opportunity to describe, discuss and display the photos. The investigators will use semi-structured interviews, questionnaires and /or focus groups to explore participants, facilitators and service providers experiences of the group CBT program and their views and perspectives on how the intervention was delivered, the content and any barriers or enablers to attending and delivering the program.
A mixed method evaluation which includes questionnaires, semi-structured interviews and/or focus groups will examine the key acceptability and implementation factors from the perspective of the participants, facilitators and service providers to explore acceptability, feasibility and appropriateness of the program, fidelity, barriers and enablers to implementation and trial process data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The biostatistician will be masked (blinded).
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be enrolled into the RCT only if they meet all the inclusion criteria and none of the
排除标准
- •Inclusion Criteria:
- •Identifies as trans, non-binary, or gender diverse
- •Is between the ages of 12 and 17 years inclusive
- •Has completed primary school at the time of enrolment into the study
- •Has current psychological stress symptomology as determined by a score of moderate or above on the DASS-Y
- •Provide informed consent: All participants and parent/legal guardians must be willing to give informed consent
- •Exclusion Criteria:
- •Has current acute suicidal symptomology as determined by a combination of clinical judgement and the results of the Ask Suicide-Screening Questions (ASQ) suicide screening tool (e.g., answer yes to question 5) to determine the risk of suicide (has an active plan and/or intent to suicide) at time of screening interview
- •Is actively having treatment with any other group psychological intervention at the time of enrolment into the study
- •Is not proficient in English (as the group Cognitive behaviour therapy (CBT) program will be delivered in English and funds aren't available for interpreters)
- •Previous participation in the feasibility trial
- •Is currently enrolled in tertiary study (e.g., undergraduate university)
研究组 & 干预措施
Waitlist Control
Those randomly allocated to the waitlist control arm from the same stratum will receive TAG TEAM after waiting a total of 19 weeks.
TAG TEAM Intervention Arm
In the intervention arm Trans Adolescent Group ThErapy for Alleviating Minority stress (TAG TEAM) will be delivered in groups of 8 participants (maximum) from the same stratum. Participants will be allocated to strata based on school year level (Grades 7-9 and 10-12). Participation will occur across a 5-month period for those in the intervention arm, including approximately 2-weeks for allocation to a condition, completion of the 6-week TAG TEAM program and follow-up questionnaires at 19 weeks.
干预措施: Trans Adolescent Group ThErapy for Alleviating Minority stress (Behavioral)
结局指标
主要结局
Changes in level of psychological distress measured using the total score from the Depression Anxiety Stress Scales - Youth version (DASS-Y)
时间窗: Measured at baseline (week 0) and 6 weeks after enrolment.
The Depression Anxiety Stress Scales - Youth version (DASS-Y) will be used to measure changes in psychological distress, compared to baseline, between treatment groups (intervention versus waitlist control). DASS-Y is a simplified version of the Depression Anxiety Stress Scales (DASS) for use with 8-17-year-olds. It is a 21-item questionnaire to assess a young person's negative emotional state in the last week, scored on a 4-point ordinal scale by severity from 0 = not true, 1 = a little true, 2 = fairly true, to 3 = very true. The DASS-Y total scale is composed of 3 subscales of anxiety, depression and stress. The total instrument measures depression, anxiety and stress, overall used to measure psychological distress. The total score ranges from 0 (least psychological distress) to 63 (most psychological distress). Psychological distress will be categorised into the following ordinal scale: 0-23 - Normal, 24-29 = Mild, 30-39 = Moderate, 40-46 = Severe, and 47+ = Extremely severe.
次要结局
- Changes in level of psychological distress measured using the total score from the Depression Anxiety Stress Scales - Youth version (DASS-Y)(Measured at baseline (week 0) and 19 weeks after enrolment.)
- Changes in level of anxiety measured using the Anxiety subscale of the Depression Anxiety Stress Scales - Youth version (DASS-Y)(Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.)
- Changes in level of depression measured using the Depression subscale of the Depression Anxiety Stress Scales - Youth version (DASS-Y)(Measured at baseline (week 0), 6 weeks and 19 weeks.)
- Changes in level of Stress measured using the Stress subscale of the Depression Anxiety Stress Scales - Youth version (DASS-Y)(Measured at baseline (week 0), 6 weeks and 19 weeks.)
- Changes in Coping as measured by the Brief Coping Orientation to Problem Experienced (Brief COPE) revised questionnaire(Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.)
- Changes in Wellbeing as measured by the World Health Organization-Five Well-Being Index (WHO-5)(Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.)
- Changes in response to the minority stressor of internalised stigma as measured by the Gender Minority Stress and Resilience Measure - Adolescent version (GMSR-A)(Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.)
- Changes in response to the minority stressor of Pride in Gender as measured by the Gender Minority Stress and Resilience Measure - Adolescent version (GMSR-A)(Measured at baseline, 6 weeks and 19 weeks.)
- Changes in response to the minority stressor of Community Connectedness as measured by the Gender Minority Stress and Resilience Measure - Adolescent version (GMSR-A)(Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.)