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Идёт набор NCT07151079

TAG TEAM - Trans Adolescent Group Therapy

Без фазы С лечением Minority Stress Acceptability Psychological Distress Anxiety

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Trans Adolescent Group ThErapy for Alleviating Minority stress.
Кому может быть актуально
Состояния в реестре: Minority Stress, Acceptability, Psychological Distress, Anxiety. Базовые параметры: 12 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австралия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Trans Adolescent Group ThErapy for Alleviating Minority stress
    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

Первичные конечные точки

  • Changes in level of psychological distress measured using the total score from the Depression Anxiety Stress Scales - Youth version (DASS-Y) [Срок оценки: Measured at baseline (week 0) and 6 weeks after enrolment.]
Вторичные конечные точки (9)
  • Changes in level of psychological distress measured using the total score from the Depression Anxiety Stress Scales - Youth version (DASS-Y) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Measured at baseline (week 0), 6 weeks and 19 weeks after enrolment.]

Критерии участия

Participants will be enrolled into the RCT only if they meet all the inclusion criteria and none of the exclusion criteria.

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Австралия · 1 центр
  • Murdoch Children's Research Institute — Parkville

Публикации

  • 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

Идентификаторы

NCT: NCT07151079 · 110355

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗