Emotional RegulationNCT06237608
Acceptability and Feasibility of an Adapted DBT-informed Skills Group for Gender Diverse Young People Co-delivered in a Charity Setting
A study testing Dialectical behavioural therapy (DBT)-informed skills group in people with Emotional Regulation, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Emotional Regulation
- What is being tested?
- Dialectical behavioural therapy (DBT)-informed skills group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Feb 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-25 years old
- Identify as gender diverse
- Receiving support from Gendered Intelligence
- Support worker identified and self-report emotion regulation difficulties.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
- Is the intervention feasible to deliver in a charity setting?
- 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.
- Conditions
- Emotional Regulation
- Being tested
- Dialectical behavioural therapy (DBT)-informed skills group
- Keywords
- emotional regulation, gender diverse
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavioural therapy (DBT)-informed skills groupBehavioural
16 week 1.5hr DBT-informed skills group facilitated by the lead researcher and two charity facilitators
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Attend DBT-informed skills group intervention Receives: Behavioral: Dialectical behavioural therapy (DBT)-informed skills group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of intervention
- Short, bespoke feedback questionnaire completed at the end of each session regarding content and delivery.
Measured: 16 weeks
Acceptability of intervention
- Client Satisfaction Questionnaire will be completed post-intervention.
Measured: 16 weeks
Feasibility of intervention
- Eligibility rates at screening
Measured: 16 weeks
Feasibility of intervention
- 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.
Measured: 16 weeks
Feasibility of intervention
- 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)
Measured: 16 weeks
Feasibility of intervention
- Cost and time to train a charity support worker
Measured: 16 weeks
Feasibility of intervention
- 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)
Measured: 16 weeks
Feasibility of intervention
- Number of hours from charity to deliver the intervention
Measured: 16 weeks
Feasibility of intervention
- 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)
Measured: 16 weeks
Feasibility of intervention
- How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)
Measured: 16 weeks
Secondary outcomes (9)
Emotion dysregulation
The Difficulties in Emotion Regulation Scale. Higher scores indicate more severe emotion dysregulation difficulties.
Measured: 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
Measured: 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.
Measured: Every 2 weeks for 4 weeks, and then again after 16 weeks.
Depression
Patient Health Questionnaire. Higher scores indicate higher levels of depression.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start3 Feb 2024
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional RegulationStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 16-week LGBTQ+ -adapted DBT skills group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Gendered Intelligence
- Responsible party
- Sponsor
- Investigators
- Megan Stock, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237608
- Sponsor's protocol ID
- DBTGI24
- Status last verified
- Mar 2024
- First submitted
- 11 Jan 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of an Adapted DBT-informed Skills Group for Gender Diverse Young People Co-delivered in a Charity Setting
- ClinicalTrials.gov ID
- NCT06237608
- Acronym / sponsor ID
- DBTGI24
- Conditions
- Emotional Regulation
- Keywords
- emotional regulation, gender diverse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Gendered Intelligence
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Is the intervention feasible to deliver in a charity setting?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 16-week LGBTQ+ -adapted DBT skills group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Dialectical behavioural therapy (DBT)-informed skills groupAttend DBT-informed skills group intervention |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 16-25 years old
- Identify as gender diverse
- Receiving support from Gendered Intelligence
- Support worker identified and self-report emotion regulation difficulties.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical behavioural therapy (DBT)-informed skills group16 week 1.5hr DBT-informed skills group facilitated by the lead researcher and two charity facilitators | Behavioural | Intervention |
Primary outcome
Acceptability of intervention
Time frame: 16 weeks
1. Short, bespoke feedback questionnaire completed at the end of each session regarding content and delivery.
Acceptability of intervention
Time frame: 16 weeks
2. Client Satisfaction Questionnaire will be completed post-intervention.
Feasibility of intervention
Time frame: 16 weeks
1. Eligibility rates at screening
Feasibility of intervention
Time frame: 16 weeks
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.
Feasibility of intervention
Time frame: 16 weeks
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)
Feasibility of intervention
Time frame: 16 weeks
4. Cost and time to train a charity support worker
Feasibility of intervention
Time frame: 16 weeks
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)
Feasibility of intervention
Time frame: 16 weeks
6. Number of hours from charity to deliver the intervention
Feasibility of intervention
Time frame: 16 weeks
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)
Feasibility of intervention
Time frame: 16 weeks
8. How feasible the intervention was to deliver (via self-report questionnaire completed by the co-facilitators)
9 secondary outcomes
Emotion dysregulation
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Use of DBT coping skills
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Anxiety
Time frame: Every 2 weeks for 4 weeks, and then again after 16 weeks.
Depression
Time frame: Every 2 weeks for 4 weeks, and then again after 16 weeks.
Internalised transphobia
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Gender-related negative future expectations
Time frame: Every 2 weeks for 4 weeks, and then again after 16 weeks.
Gender-related community connectedness
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Gender-specific pride
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Suicidal behaviours
Time frame: Every 2 weeks for 4 weeks, and then every three weeks for 16 weeks once the intervention begins.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
Related trials for Emotional Regulation
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Not yet recruitingPhase 2
Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism
Autism in Children, Autistic Disorder in Children and Adolescents
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Stock principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavioural therapy (DBT)-informed skills group in people with Emotional Regulation, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of intervention (time frame: 16 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.