跳至主要内容
临床试验/NCT05841212
NCT05841212Enrolling By Invitation不适用

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

King's College London1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
25
试验地点
1
主要终点
66% of participants or more will report above neutral satisfaction ratings on weekly questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

66% of participants or more will report above neutral satisfaction ratings on weekly questionnaire

时间窗: Within 12 months

To assess whether participants will find both the intervention and assessment methods acceptable.

60% of participants or more will attend all group sessions.

时间窗: 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.

时间窗: Within12-months

To assess whether the intervention is feasible in terms of retention, for adolescents with ADHD.

25 participants with ADHD will be recruited from CAMHS services.

时间窗: Within12-months

To assess whether the intervention is feasible in terms of recruitment, for adolescents with ADHD.

Individual participant attendance rate will be greater than 50%.

时间窗: Within12-months

To assess whether the intervention is feasible in terms of retention, for adolescents with ADHD.

66% of participants or more from the focus group will report above neutral satisfaction.

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Unknown
不适用
Support for PARents of Children Living With ADHD - a Research TrialAttention Deficit Disorder With Hyperactivity
NCT03832270University of Glasgow60
Unknown
不适用
Effectiveness of a Therapeutic Education Program in Improving Quality of Life of Children With ADHD and Their ParentsAttention Deficit Disorder
NCT05133284University Hospital, Montpellier24
已完成
不适用
Screening for Attention-deficit/Hyperactivity Disorder (ADHD) in Adolescent and Adult High Risk PopulationsAttention Deficit Disorder With Hyperactivity
NCT00745524National Taiwan University Hospital1,910
终止
4 期
Methylphenidate vs. Risperidone for the Treatment of Children and Adolescents With ADHD and Disruptive DisordersAttention Deficit/Hyperactivity DisorderOppositional Defiant DisorderConduct Disorder
NCT02063945Sheba Medical Center5
进行中(未招募)
不适用
Attention Deficit Hyperactivity Disorder (ADHD) and opioid maintenance therapy.A randomized, placebo-controlled study of the efficacy of atomoxetine for treating adult ADHD in patients receiving opioid maintenance therapyPatients will be recruited from out-patient clinics treating opioid dependent patients with buprenorphine or methadone maintenance therapy. Patients will be screened for ADHD symptoms. Based on the screen results, patients will undergo medical and psychiatric assessment to identify those meeting the criteria for adult ADHD. Patients diagnosed with comorbid ADHD and opioid dependence will then be randomized into atomoxetine and placebo study groups.MedDRA version: 12.1Level: LLTClassification code 10064104Term: ADHD
EUCTR2010-019981-94-FIHUS/ Neuropsykiatrian poliklinikka30
DBT Skills Group for Adolescents with ADHD | 临床试验