DBT Skills Group for Adolescents With ADHD

ADHD Clinical Trial

Official title:

The Acceptability and Feasibility of Implementing a Dialectical Behaviour Therapy (DBT) Skills Group for Adolescents With ADHD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05841212
• Other study ID #: IRAS321708
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2023
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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]

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• ADHD

Intervention

Other:
• DBT for ADHD
See information included in arm/group description.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	South London and Maudsley NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within12-months
Primary	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.	Within12-months
Primary	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.	Within12-months
Primary	Individual participant attendance rate will be greater than 50%.	To assess whether the intervention is feasible in terms of retention, for adolescents with ADHD.	Within12-months
Primary	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.	Within 12 months
Primary	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.	Within 12 months
Secondary	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.	Within 12 months
Secondary	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.	Within 12 months
Secondary	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.	Within 12 months
Secondary	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.	Within 12 months