AzTrials
AzTrials

Minority StressTAG TEAMNCT07151079

TAG TEAM - Trans Adolescent Group Therapy

A study testing Trans Adolescent Group ThErapy for Alleviating Minority stress in people with Minority Stress and Acceptability, run by Murdoch Childrens Research Institute at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 12 to 17 years
What is being tested?
Trans Adolescent Group ThErapy for Alleviating Minority stress
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteAustralia
Study dates
21 May 2026to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Timothy J Cronin, PhD contact

+61393456991

tagteam@mcri.edu.au

Australia1 site, 1 recruiting
  • Murdoch Children's Research Institute

    Parkville, Victoria, 3052

    Timothy Cronin, PhD, +61393456991, tagteam@mcri.edu.au

    Timothy J Cronin, PhD

    Recruiting

Other trials in Australia

About this study

Official title: Evaluation of Trans Adolescent Group ThErapy for Alleviating Minority Stress (TAG TEAM): a Randomised Controlled Trial

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.

Read the detailed description

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.

Being tested
Trans Adolescent Group ThErapy for Alleviating Minority stress
Keywords
Adolescent, Trans and gender diverse, Minority stress, Wellbeing, Group Therapy, CBT
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trans Adolescent Group ThErapy for Alleviating Minority stressBehavioural

    The intervention, 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 to target minority stressors discrimination and internalised stigma and facilitating community connection and pride. The intervention will be delivered by a psychologist facilitator and peer facilitator, who will both be trained and supervised by clinical psychologists, to groups of 8 participants from the same stratum.

Study groups in NCT07151079
Study groupRoleWhat they receive
TAG TEAM Intervention ArmExperimentalIn 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.
Receives: Behavioral: Trans Adolescent Group ThErapy for Alleviating Minority stress
Waitlist ControlNo interventionThose randomly allocated to the waitlist control arm from the same stratum will receive TAG TEAM after waiting a total of 19 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in level of psychological distress measured using the total score from the Depression Anxiety Stress Scales - Youth version (DASS-Y)

    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.

    Measured: Measured at baseline (week 0) and 6 weeks after enrolment.

Secondary outcomes (9)
  1. Changes in level of psychological distress measured using the total score from the Depression Anxiety Stress Scales - Youth version (DASS-Y)

    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.

    Measured: Measured at baseline (week 0) and 19 weeks after enrolment.

  2. Changes in level of anxiety measured using the Anxiety subscale of the Depression Anxiety Stress Scales - Youth version (DASS-Y)

    The Depression Anxiety Stress Scales - Youth version (DASS-Y) will be used to measure changes in anxiety, 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. The DASS-Y Anxiety subscale is a 7-item questionnaire to assess a young person's anxiety 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. Questions reflect both autonomous and subjective feelings of anxiety and panic for example 'I felt scared for no reason' and 'I could feel my heart beating' and 'I felt dizzy like I was going to faint'.

    The Anxiety subscale of the DASS-Y ranges from 0 (least anxiety) to 21 (most anxiety). Anxiety scores will be categorised into the following ordinal scale: 0-5 = Normal, 6-7 = Mild, 8-12 = Moderate, 13-15 = Severe, and 16+ = Extremely severe.

    Measured: Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.

  3. Changes in level of depression measured using the Depression subscale of the Depression Anxiety Stress Scales - Youth version (DASS-Y)

    The Depression Anxiety Stress Scales - Youth version (DASS-Y) will be used to measure changes in depression, 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. The DASS-Y Depression subscale is a 7-item questionnaire to assess a young person's anxiety 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. Questions reflect both autonomous and subjective feelings of depression for example 'I hated my life' and 'I could not help feeling sad' and 'There was nothing nice I could look forward to'.

    The Depression subscale of the DASS-Y ranges from 0 (least depression) to 21 (most depression). Depression scores will be categorised into the following ordinal scale: 0-6 = Normal, 7-8 = Mild, 9-13 = Moderate, 14-16 = Severe, and 17+ = Extremely severe.

    Measured: Measured at baseline (week 0), 6 weeks and 19 weeks.

  4. Changes in level of Stress measured using the Stress subscale of the Depression Anxiety Stress Scales - Youth version (DASS-Y)

    The Depression Anxiety Stress Scales - Youth version (DASS-Y) will be used to measure changes in Stress, 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. The DASS-Y Stress subscale is a 7-item questionnaire to assess a young person's anxiety in the last week, scored on a 4-point ordinal scale by severity from 0 = not true, 1 = a little true, 2 = fairly t. Questions reflect difficulty relaxing and irritability for example 'I got upset about the little things' and 'I found it difficult to relax' and 'I was easily annoyed'.

    The Stress subscale of the DASS-Y ranges from 0 (least stress) to 21 (most stress). Stress scores will be categorised into the following ordinal scale: 0-11 = Normal, 12-13 = Mild, 14-16 = Moderate, 17-18 = Severe and 19+ = Extremely severe.

    Measured: Measured at baseline (week 0), 6 weeks and 19 weeks.

  5. Changes in Coping as measured by the Brief Coping Orientation to Problem Experienced (Brief COPE) revised questionnaire

    Changes in participants' Coping compared to baseline, between treatment groups (intervention versus waitlist control) will be measured using the active coping, self-blame, planning, positive reframing and social withdrawal subscales of the Brief Coping Orientation to Problem Experienced (Brief COPE) revised questionnaire.

    Brief COPE revised is a measure of different types of coping and has been revised for adolescents 13-24 years: questions have been simplified and an item added to each subscale to improve reliability. 18 items will be used to assess 3 forms of coping (problem-focused, avoidant and emotion-focused). This study will use 6 subscales (active coping, positive reframing, planning, social withdrawal, acceptance and self-blame).

    Responses are based on a 4-point Likert scale from 1= "I haven't been doing this at all" to 4 = "I've been doing this a lot". On each subscale, low scores indicate low use of that particular coping strategy and vice versa. There is no total score

    Measured: Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.

  6. Changes in Wellbeing as measured by the World Health Organization-Five Well-Being Index (WHO-5)

    Changes in participants' Wellbeing, compared to baseline, between treatment groups (intervention versus waitlist control) will be measured using the World Health Organization-Five Well-Being Index (WHO-5).

    The WHO-5 wellbeing index is a validated 5-item scale measuring wellbeing over the last two weeks for children 9 years and above. Questions include 'I have felt calm and relaxed' and 'My daily life has been filled with things that interest me'. Scores range from 0 = at no time and 5 = all of the time, with the total score multiplied by 4 to obtain a score out of 100 as the "best" wellbeing possible where 0 is the worst wellbeing possible.

    Measured: Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.

  7. Changes in response to the minority stressor of internalised stigma as measured by the Gender Minority Stress and Resilience Measure - Adolescent version (GMSR-A)

    Changes in response to minority stressor of Internalised Stigma, compared to baseline, between treatment groups (intervention versus waitlist control) will be measured using the Gender Minority Stress and Resilience Measure - Adolescent version (GMSR-A)

    Specifically, internalised stigma, community connection, and pride will be measured using the internalised stigma, community connection, and pride subscales of the GMSR-A. The 8-item Internalised Transphobia subscale will be used to measure Internalised Stigma on a 5-point scale i.e. 0-4 ordinal scale. For example, one item states, 'I resent my gender identity or expression' and responses range from 0 (strongly disagree) to 4 (strongly agree). The highest score for this subscale is 32 where a higher score indicates higher Internalised Stigma and vice versa.

    Measured: Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.

  8. 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)

    Changes in response to minority stressor of pride in gender, compared to baseline, between treatment groups (intervention versus waitlist control) will be measured using the Gender Minority Stress and Resilience Measure - Adolescent version (GMSR-A)

    Specifically, internalised stigma, community connection, and pride will be measured using the internalised stigma, community connection, and pride subscales of the GMSR-A. The 8-item Pride subscale assesses internalised stigma on a 5-point scale i.e. 0-4 ordinal scale. For example, one item states 'My gender identity or expression makes me feel special and unique' and responses range from 0 (strongly disagree) to 4 (strongly agree). The highest score for this subscale is 32, where a higher score indicates higher levels of Pride and vice versa.

    Measured: Measured at baseline, 6 weeks and 19 weeks.

  9. Changes in response to the minority stressor of Community Connectedness as measured by the Gender Minority Stress and Resilience Measure - Adolescent version (GMSR-A)

    Changes in response to minority stressor of Community Connectedness, compared to baseline, between treatment groups (intervention versus waitlist control) will be measured using the Gender Minority Stress and Resilience Measure - Adolescent version (GMSR-A)

    Specifically, internalised stigma, community connection, and pride will be measured using the internalised stigma, community connection, and pride subscales of the GMSR-A. The 5-item Community Connectedness subscale assesses internalised stigma of transphobia on a 5-point scale i.e. 0-4 ordinal scale. For example, one item states 'I feel like I belong' with responses ranging from 0 (strongly disagree) to 4 (strongly agree). The highest score for this subscale is 20 where a higher score indicates higher Community Connectedness and vice versa.

    Measured: Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2025
  2. Study start21 May 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07151079
Sponsor's protocol ID
110355
Acronym
TAG TEAM
Status last verified
Mar 2026
First submitted
27 Aug 2025
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article after de-identification, upon reasonable request.

Publications

  • Chinsen A, Cronin TJ, Pace CC, Tollit MA, Pang KC. Evaluation of a codesigned group cognitive-behavioural therapy intervention for trans young people (TAG TEAM): protocol for a feasibility trial and a subsequent pilot RCT. BMJ Open. 2024 Jan 10;14(1):e076511. doi: 10.1136/bmjopen-2023-076511.

    PubMed 38199639

Questions about this trial

What is this clinical trial studying?

A study testing Trans Adolescent Group ThErapy for Alleviating Minority stress in people with Minority Stress and Acceptability, run by Murdoch Childrens Research Institute at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Timothy J Cronin, PhD (+61393456991, tagteam@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in level of psychological distress measured using the total score from the Depression Anxiety Stress Scales - Youth version (DASS-Y) (time frame: Measured at baseline (week 0) and 6 weeks after enrolment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07151079, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in