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Enrolling by Invitation

NCT Number: NCT05841212

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.

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Key information

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South London and Maudsley Foundation Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBT for ADHD

Other

See information included in arm/group description.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

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

    Time frame: Within 12 months

    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.

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

    Time frame: Within 12 months

    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.

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

    Time frame: Within 12 months

    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.

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

    Time frame: Within 12 months

    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.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • South London and Maudsley NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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