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

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.

Study Overview

• Status: Completed
• Conditions: Emotional Regulation
• Intervention / Treatment: Behavioral: Dialectical behavioural therapy (DBT)-informed skills group

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 8AN
    • King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Attend DBT-informed skills group intervention	Behavioral: Dialectical behavioural therapy (DBT)-informed skills group; 16 week 1.5hr DBT-informed skills group facilitated by the lead researcher and two charity facilitators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion dysregulation	The Difficulties in Emotion Regulation Scale. Higher scores indicate more severe emotion dysregulation difficulties.	Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Use of DBT coping skills	The DBT Ways of Coping Checklist	Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Anxiety	Generalised Anxiety Disorder Assessment. Higher scores indicate higher levels of anxiety.	Every 2 weeks for 4 weeks, and then again after 16 weeks.
Depression	Patient Health Questionnaire. Higher scores indicate higher levels of depression.	Every 2 weeks for 4 weeks, and then again after 16 weeks.
Internalised transphobia	Gender Minority Stress and Resilience Measure. Higher scores indicate higher internalised transphobia.	Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Gender-related negative future expectations	Gender Minority Stress and Resilience Measure. Higher scores indicate higher gender-related negative future expectations.	Every 2 weeks for 4 weeks, and then again after 16 weeks.
Gender-related community connectedness	Gender Minority Stress and Resilience Measure. Higher scores indicate higher gender-related community connectedness.	Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Gender-specific pride	Gender Minority Stress and Resilience Measure. Higher scores indicate higher gender-specific pride	Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Suicidal behaviours	Frequencies of self-harm, suicidal behaviours, A&E attendances, and inpatient bed days.	Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Gendered Intelligence
• Investigators: Principal Investigator: Megan Stock, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: emotional regulation; gender diverse
• Other Study ID Numbers: DBTGI24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No