DBT Skills Group for Adolescents with ADHD

NCT05841212 | Enrolling By Invitation DMC

• 1 other identifier: IRAS321708
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• At post-treatment compared to baseline participants will report improved levels of emotion regulation

  Within 12 months

• At post-treatment compared to baseline participants will report a reduction in ADHD symptoms.

  Within 12 months

• At post treatment compared to baseline participants will report improved social skills and functioning.

  Within 12 months

• At post treatment compared to baseline participants will report improved social skills and functioning.

  Within 12 months

Study Arms (1)

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.

Other: DBT for ADHD

Interventions

DBT for ADHD OTHER

See information included in arm/group description.

DBT for ADHD

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[for intervention part\]

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

South London and Maudsley Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 3, 2023
• Study Start: February 27, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)