TAG TEAM - Trans Adolescent Group Therapy

NCT07151079 | Not Yet Recruiting

• 1 other identifier: 110355
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acceptability; Anxiety; Depression in Adolescence; Coping; Wellbeing; Pride; Internalised Stigma; Community Connection; Minority Stress; Psychological Distress

Keywords

Adolescent; Trans and gender diverse; Minority stress; Wellbeing; Group Therapy; CBT

Outcome Measures

Primary Outcomes (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 at baseline (week 0) and 6 weeks after enrolment.

Secondary Outcomes (9)

• 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.

Study Arms (2)

TAG TEAM Intervention Arm

EXPERIMENTAL

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.

Behavioral: Trans Adolescent Group ThErapy for Alleviating Minority stress

Waitlist Control

NO INTERVENTION

Those randomly allocated to the waitlist control arm from the same stratum will receive TAG TEAM after waiting a total of 19 weeks.

Interventions

Trans Adolescent Group ThErapy for Alleviating Minority stress BEHAVIORAL

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.

TAG TEAM Intervention Arm

Eligibility Criteria

• Age: 12 Years - 17 Years
• Gender Eligibility Details: Transgender, non-binary and other gender diverse participants
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

Murdoch Children's Research Institute

Parkville, Victoria, 3052, Australia

Location

Related Publications (1)

• 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.

  PMID: 38199639 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Timothy J Cronin, PhD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy J Cronin, PhD

CONTACT

+61393456991; tagteam@mcri.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The biostatistician will be masked (blinded).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 3, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months following analysis and article publication, the previously described data will be available while it is being actively stored by the researchers i.e., 15 years.
• Access Criteria: Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access.

Locations

AU (1)