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

Emotional Regulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06237608
• Other study ID #: DBTGI24
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 3, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Regulation

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

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Gendered Intelligence

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of intervention	1. Short, bespoke feedback questionnaire completed at the end of each session regarding content and delivery.	16 weeks
Primary	Acceptability of intervention	2. Client Satisfaction Questionnaire will be completed post-intervention.	16 weeks
Primary	Feasibility of intervention	1. Eligibility rates at screening	16 weeks
Primary	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
Primary	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
Primary	Feasibility of intervention	4. Cost and time to train a charity support worker	16 weeks
Primary	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
Primary	Feasibility of intervention	6. Number of hours from charity to deliver the intervention	16 weeks
Primary	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
Primary	Feasibility of intervention	8. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)	16 weeks
Secondary	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.
Secondary	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.
Secondary	Anxiety	Generalised Anxiety Disorder Assessment. Higher scores indicate higher levels of anxiety.	Every 2 weeks for 4 weeks, and then again after 16 weeks.
Secondary	Depression	Patient Health Questionnaire. Higher scores indicate higher levels of depression.	Every 2 weeks for 4 weeks, and then again after 16 weeks.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.