Clinical trial NCT06237608: Acceptability and Feasibility of an Adapted DBT-informed Skills Group for Gender Diverse Young People Co-delivered in a Charity Setting
Official title: Acceptability and Feasibility of an Adapted DBT-informed Skills Group for Gender Diverse Young People Co-delivered in a Charity Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Regulation
Keywords: emotional regulation
gender diverse
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Gendered Intelligence
First posted: 2024-02-01
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 16-week LGBTQ+ -adapted DBT skills group
Primary purpose: TREATMENT

Brief summary: Gender diverse (e.g. trans or non-binary) young people are at higher risk of self-harm and may be more likely to access support through gender-diverse-specific 3rd sector charities. Dialectical behavioural therapy (DBT) is a transdiagnostic intervention targeting emotion dysregulation, self-harm and suicidality and is recommended by best-practice clinical guidelines; There is developing evidence that DBT skills training can be offered as an effective stand-alone intervention.The current study, therefore, aims to evaluate the feasibility, acceptability and early indicators of effectiveness of a DBT-informed skills group intervention in a gender diverse charity setting. The intervention will be co-facilitated with a gender-diverse support worker from the charity to develop the therapeutic skills of the charity staff working with the young people, whilst they provide specialist knowledge and valuable lived experience.

Research questions

1. Is the intervention feasible to deliver in a charity setting?
2. Is the intervention acceptable to participants and charity facilitators?

Participants will attend a 16-week group intervention. They will complete questionnaire to assess acceptability at the end of the intervention. Attrition rates, training time, and questionnaires will be used to assess feasibility. Outcome measures will also be completed by the participants every three weeks to indicate possible effectiveness of the intervention. The outcomes will include emotion dysregulation, coping skills, anxiety, depression and suicidal behaviours.


Eligibility criteria: Inclusion Criteria:

* Age 16-25 years old
* Identify as gender diverse
* Receiving support from Gendered Intelligence
* Support worker identified and self-report emotion regulation difficulties.

Exclusion Criteria:

* In acute crisis at point of recruitment and start of the intervention such as active suicidal ideation with active plans, or severe self-harm requiring intensive interventions such as inpatient or crisis care.

Primary outcomes:
measure: Acceptability of intervention
timeFrame: 16 weeks
measure: Acceptability of intervention
timeFrame: 16 weeks
measure: Feasibility of intervention
timeFrame: 16 weeks
measure: Feasibility of intervention
timeFrame: 16 weeks
measure: Feasibility of intervention
timeFrame: 16 weeks
measure: Feasibility of intervention
timeFrame: 16 weeks
measure: Feasibility of intervention
timeFrame: 16 weeks
measure: Feasibility of intervention
timeFrame: 16 weeks
measure: Feasibility of intervention
timeFrame: 16 weeks
measure: Feasibility of intervention
timeFrame: 16 weeks
Secondary outcomes:
measure: Emotion dysregulation
timeFrame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
measure: Use of DBT coping skills
timeFrame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
measure: Anxiety
timeFrame: Every 2 weeks for 4 weeks, and then again after 16 weeks.
measure: Depression
timeFrame: Every 2 weeks for 4 weeks, and then again after 16 weeks.
measure: Internalised transphobia
timeFrame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
measure: Gender-related negative future expectations
timeFrame: Every 2 weeks for 4 weeks, and then again after 16 weeks.
measure: Gender-related community connectedness
timeFrame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
measure: Gender-specific pride
timeFrame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
measure: Suicidal behaviours
timeFrame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Megan Stock
role: PRINCIPAL_INVESTIGATOR
References: