ADHDNCT05841212
DBT Skills Group for Adolescents with ADHD
A study testing DBT for ADHD in people with ADHD, run by King's College London at 1 site in United Kingdom.
Trial summary
Attention Deficit Hyperactive Disorder (ADHD) is linked to three main symptoms: hyperactivity, inattention and impulsivity. It is increasingly being acknowledged that these symptoms have a wide-reaching impact on a person's life. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- ADHD
- What is being tested?
- DBT for ADHD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Feb 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Attention Deficit Hyperactive disorder (using either DSM 5, DSM-IV, or ICD-10 - F90)
- Age 13-16 years
- Likely to benefit from DBT skills and can safely access/ engage in group interventions as assessed by clinical team [for intervention part]
Who cannot join
- A low enough proficiency in written and spoken English that they would be unable to engage in the content of the group.
- Have not recently changed their medication in the last 2 weeks*, commenced a new medication in the last 2 weeks* or are receiving additional concurrent psychological intervention. (*calculated from the start of the intervention).
- The identified participant has recently taken part in another research trial and are at risk of research burden.
- Pose a risk to others in the group
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Acceptability and Feasibility of Implementing a Dialectical Behaviour Therapy (DBT) Skills Group for Adolescents with ADHD
Attention Deficit Hyperactive Disorder (ADHD) is linked to three main symptoms: hyperactivity, inattention and impulsivity. It is increasingly being acknowledged that these symptoms have a wide-reaching impact on a person's life. Adolescents with ADHD are six times more likely to be excluded from school, have difficulties turn taking, express anger more often, have poorer emotion regulation and self-report a lower quality of life. In adulthood, people with ADHD are more likely to develop mental health difficulties, and to experience unemployment, divorce and be imprisoned. It is thought that emotion regulation and poor social skills are key factors leading to increases in mental health difficulties and poorer long term social outcomes. This pilot trial will look at whether an intervention which aims to increase emotion regulation and social functioning is acceptable and feasible. The intervention will be an adapted Dialectical Behaviour Therapy (DBT) skills group with an ADHD focus. DBT is an approach that aims to provide skills to assist an individual identify what they are feeling and change what they do in response to that feeling. For example, if an individual feels anger and the urge to be aggressive, DBT helps them to problem solve and find a more effective way of responding to their anger. Also, if an individual wants to communicate a relational need to others DBT helps them think about the most effective actions they can take to achieve this outcome. The intervention will be developed in collaboration with adolescents with ADHD. The intervention will then be delivered at the child and adolescent outpatient clinic site they received their diagnosis from. All participants will have a confirmed diagnosis of ADHD. Pre and post measures will be collected and reported on. The research team hope to commence recruitment in July 2023 and finish all data collection by 31st March 2024.
- Conditions
- ADHD
- Being tested
- DBT for ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT for ADHDOther
See information included in arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| DBT for ADHD | Other | The intervention will consist of a DBT skills group. Its name, length, style and content will be guided by the viewpoints shared in the intervention planning focus group/ individual interviews, and taken into consideration alongside a clinical rational and the evidence-based content. It will include skills from all four of the DBT modules: Mindfulness, Distress Tolerance, emotion regulation and interpersonal effectiveness. There will be an emphasis on the skills relevant to ADHD symptoms plus a core psychoeducational component on ADHD symptoms. The intervention will be adapted from Rathus and Miller's (2014) DBT for adolescents (DBT-A) manual.
The group format will be didactic teaching with group discussion and experiential exercises to aid learning. Receives: Other: DBT for ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
25 participants with ADHD will be recruited from CAMHS services.
To assess whether the intervention is feasible in terms of recruitment, for adolescents with ADHD.
Measured: Within12-months
60% of participants or more will attend all group sessions.
To assess whether the intervention is feasible in terms of retention, for adolescents with ADHD.
Measured: Within12-months
60% or more of participants will complete a follow up measures.
To assess whether the intervention is feasible in terms of retention, for adolescents with ADHD.
Measured: Within12-months
Individual participant attendance rate will be greater than 50%.
To assess whether the intervention is feasible in terms of retention, for adolescents with ADHD.
Measured: Within12-months
66% of participants or more will report above neutral satisfaction ratings on weekly questionnaire
To assess whether participants will find both the intervention and assessment methods acceptable.
Measured: Within 12 months
66% of participants or more from the focus group will report above neutral satisfaction.
To assess whether participants will find both the intervention and assessment methods acceptable, we will conduct a focus group and use thematic analysis to ascertain the satisfaction rating.
Measured: Within 12 months
Secondary outcomes (4)
At post-treatment compared to baseline participants will report improved levels of emotion regulation
Participants will complete the DERS-SF (2015) pre and post the intervention. We will report on any changes between baseline and post treatment score using effect sizes and confidence intervals. As this is a pilot trial tentative conclusions will be drawn from these findings.
Measured: Within 12 months
At post-treatment compared to baseline participants will report a reduction in ADHD symptoms.
Participants will complete the Connors 3rd edition self report form and SNAP-IV-26 (1992) pre and post the intervention. We will report on any changes between baseline and post treatment score using effect sizes and confidence intervals. As this is a pilot trial tentative conclusions will be drawn from these findings.
Measured: Within 12 months
At post treatment compared to baseline participants will report improved social skills and functioning.
Participants will complete the WSAS-Y (2019) pre and post the intervention. We will report on any changes between baseline and post treatment score using effect sizes and confidence intervals. As this is a pilot trial tentative conclusions will be drawn from these findings.
Measured: Within 12 months
At post treatment compared to baseline participants will report improved social skills and functioning.
Participants will complete the SDQ (2005) pre and post the intervention. We will report on any changes between baseline and post treatment score using effect sizes and confidence intervals. As this is a pilot trial tentative conclusions will be drawn from these findings.
Measured: Within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start27 Feb 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841212
- Sponsor's protocol ID
- IRAS321708
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acceptability and Feasibility of Implementing a Dialectical Behaviour Therapy (DBT) Skills Group for Adolescents with ADHD
- ClinicalTrials.gov ID
- NCT05841212
- Acronym / sponsor ID
- IRAS321708
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 May 2023 (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.
Attention Deficit Hyperactive Disorder (ADHD) is linked to three main symptoms: hyperactivity, inattention and impulsivity. It is increasingly being acknowledged that these symptoms have a wide-reaching impact on a person's life. Adolescents with ADHD are six times more likely to be excluded from school, have difficulties turn taking, express anger more often, have poorer emotion regulation and self-report a lower quality of life. In adulthood, people with ADHD are more likely to develop mental health difficulties, and to experience unemployment, divorce and be imprisoned. It is thought that emotion regulation and poor social skills are key factors leading to increases in mental health difficulties and poorer long term social outcomes. This pilot trial will look at whether an intervention which aims to increase emotion regulation and social functioning is acceptable and feasible. The intervention will be an adapted Dialectical Behaviour Therapy (DBT) skills group with an ADHD focus. DBT is an approach that aims to provide skills to assist an individual identify what they are feeling and change what they do in response to that feeling. For example, if an individual feels anger and the urge to be aggressive, DBT helps them to problem solve and find a more effective way of responding to their anger. Also, if an individual wants to communicate a relational need to others DBT helps them think about the most effective actions they can take to achieve this outcome. The intervention will be developed in collaboration with adolescents with ADHD. The intervention will then be delivered at the child and adolescent outpatient clinic site they received their diagnosis from. All participants will have a confirmed diagnosis of ADHD. Pre and post measures will be collected and reported on. The research team hope to commence recruitment in July 2023 and finish all data collection by 31st March 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBT for ADHD | Other | Other: DBT for ADHDThe intervention will consist of a DBT skills group. Its name, length, style and content will be guided by the viewpoints shared in the intervention planning focus group/ individual interviews, and taken into consideration alongside a clinical rational and the evidence-based content. It will include skills from all four of the DBT modules: Mindfulness, Distress Tolerance, emotion regulation and interpersonal effectiveness. There will be an emphasis on the skills relevant to ADHD symptoms plus a core psychoeducational component on ADHD symptoms. The intervention will be adapted from Rathus and Miller's (2014) DBT for adolescents (DBT-A) manual. The group format will be didactic teaching with group discussion and experiential exercises to aid learning. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of Attention Deficit Hyperactive disorder (using either DSM 5, DSM-IV, or ICD-10 - F90)
- Age 13-16 years
- Likely to benefit from DBT skills and can safely access/ engage in group interventions as assessed by clinical team [for intervention part]
Key exclusion criteria (4 listed)
- A low enough proficiency in written and spoken English that they would be unable to engage in the content of the group.
- Have not recently changed their medication in the last 2 weeks*, commenced a new medication in the last 2 weeks* or are receiving additional concurrent psychological intervention. (*calculated from the start of the intervention).
- The identified participant has recently taken part in another research trial and are at risk of research burden.
- Pose a risk to others in the group
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 |
|---|---|---|
| DBT for ADHDSee information included in arm/group description. | Other | DBT for ADHD |
Primary outcome
25 participants with ADHD will be recruited from CAMHS services.
Time frame: Within12-months
To assess whether the intervention is feasible in terms of recruitment, for adolescents with ADHD.
60% of participants or more will attend all group sessions.
Time frame: Within12-months
To assess whether the intervention is feasible in terms of retention, for adolescents with ADHD.
60% or more of participants will complete a follow up measures.
Time frame: Within12-months
To assess whether the intervention is feasible in terms of retention, for adolescents with ADHD.
Individual participant attendance rate will be greater than 50%.
Time frame: Within12-months
To assess whether the intervention is feasible in terms of retention, for adolescents with ADHD.
66% of participants or more will report above neutral satisfaction ratings on weekly questionnaire
Time frame: Within 12 months
To assess whether participants will find both the intervention and assessment methods acceptable.
66% of participants or more from the focus group will report above neutral satisfaction.
Time frame: Within 12 months
To assess whether participants will find both the intervention and assessment methods acceptable, we will conduct a focus group and use thematic analysis to ascertain the satisfaction rating.
4 secondary outcomes
At post-treatment compared to baseline participants will report improved levels of emotion regulation
Time frame: Within 12 months
At post-treatment compared to baseline participants will report a reduction in ADHD symptoms.
Time frame: Within 12 months
At post treatment compared to baseline participants will report improved social skills and functioning.
Time frame: Within 12 months
At post treatment compared to baseline participants will report improved social skills and functioning.
Time frame: Within 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT for ADHD in people with ADHD, 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 6 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
25 participants with ADHD will be recruited from CAMHS services. (time frame: Within12-months). The study lists 6 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 6 Mar 2025.