Acceptability and Feasibility of an Adapted DBT-informed Skills Group for Gender Diverse Young People Co-delivered in a Charity Setting

NCT06237608 | Completed

• 1 other identifier: DBTGI24
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Emotional Regulation

Keywords

emotional regulation; gender diverse

Outcome Measures

Primary Outcomes (10)

• Acceptability of intervention

  1\. Short, bespoke feedback questionnaire completed at the end of each session regarding content and delivery.

  16 weeks

• Acceptability of intervention

  2\. Client Satisfaction Questionnaire will be completed post-intervention.

  16 weeks

• Feasibility of intervention

  1\. Eligibility rates at screening

  16 weeks

• Feasibility of intervention

  2\. Attrition rates at each stage of recruitment - initial number of participants identified by Gendered Intelligence, number of participants approached, number of participants who consented to discuss the project with the researcher, number of participants who consented to take part, number of participants who completed treatment.

  16 weeks

• Feasibility of intervention

  3\. Attendance and completion rates of the intervention 4. Cost and time to train a charity support worker 5. Number of clinician hours to deliver the intervention and outcome monitoring 6. Number of hours from charity to deliver the intervention 7. How feasible the intervention was to attend (via self-report questionnaire) 8. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)

  16 weeks

• Feasibility of intervention

  4\. Cost and time to train a charity support worker

  16 weeks

• Feasibility of intervention

  5\. Number of clinician hours to deliver the intervention and outcome monitoring 6. Number of hours from charity to deliver the intervention 7. How feasible the intervention was to attend (via self-report questionnaire) 8. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)

  16 weeks

• Feasibility of intervention

  6\. Number of hours from charity to deliver the intervention

  16 weeks

• Feasibility of intervention

  7\. How feasible the intervention was to attend (via self-report questionnaire) 8. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)

  16 weeks

• Feasibility of intervention

  8\. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)

  16 weeks

Secondary Outcomes (9)

• Emotion dysregulation

  Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.

• Use of DBT coping skills

  Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.

• Anxiety

  Every 2 weeks for 4 weeks, and then again after 16 weeks.

• Depression

  Every 2 weeks for 4 weeks, and then again after 16 weeks.

• Internalised transphobia

  Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.

Study Arms (1)

Intervention

EXPERIMENTAL

Attend DBT-informed skills group intervention

Behavioral: Dialectical behavioural therapy (DBT)-informed skills group

Interventions

Dialectical behavioural therapy (DBT)-informed skills group BEHAVIORAL

16 week 1.5hr DBT-informed skills group facilitated by the lead researcher and two charity facilitators

Intervention

Eligibility Criteria

• Age: 16 Years - 25 Years
• Gender Eligibility Details: Identify as gender diverse- Gender diversity refers to the representation of people whose gender identity does not conform to socially defined norms. This includes (but is not restricted to) transgender people (whose gender identity does not correspond with their assigned sex at birth) and non-binary people (whose gender identity does not fit within the gender binary of male or female).
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Gendered Intelligence: collaborator

Study Sites (1)

King's College London

London, SE5 8AN, United Kingdom

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Megan Stock

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 16-week LGBTQ+ -adapted DBT skills group

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 1, 2024
• Study Start: February 3, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 2, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)