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

Phase 1

Active, not recruiting

• Conditions: Emotional Regulation
• Interventions: Behavioral: Dialectical behavioural therapy (DBT)-informed skills group

• Registration Number: NCT06237608
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-01
• Study Start: 2024-02-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Dialectical behavioural therapy (DBT)-informed skills group	Attend DBT-informed skills group intervention

Primary Outcome Measures

Name	Time	Method
Feasibility of intervention	16 weeks	8. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)
Acceptability of intervention	16 weeks	2. Client Satisfaction Questionnaire will be completed post-intervention.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom