跳至主要内容
临床试验/NCT04832737
NCT04832737已完成不适用

Could a Strength- Based Treatment Improve Self-management in Adults With Attention Deficit Hyperactivity Disorder

University of Huddersfield4 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
4
主要终点
Patient Heath Questionniare (PHQ)- 9

研究概览

简要总结

The aim of the research is to develop a treatment program with positive self-awareness and self-determination outcomes for adults with Attention Deficit Hyperactivity Disorder (ADHD). Current treatments are based in a characterisation of ADHD oriented on deficits impairing everyday functioning, with primary goals of symptom control and reduction. However, treatment approaches are not standardised and only evidence short-term effectiveness. This project proposes an alternative approach to understanding ADHD behaviours, supported by Self Determination Theory (SDT). Research shows SDT based treatment approaches can support engagement of intrinsic motivation and longterm integration of behavioural change. ADHD research shows individuals are impaired in some contexts but not in others and can manage well, indicating potential for ADHD neurodiverse "strengths" which could be developed and supported. Recent psychology research recommends cultivating positive psychological factors and emotions to improve mental health and wellbeing. Adults aged 18+ with a confirmed ADHD diagnosis will be invited to participate in two projects: Intensive online interviews of 1 hour will be conducted to identify, explore, and construct a theory about the factors, or "natural strengths" in lived experience of ADHD that help individuals to overcome everyday impairments. These factors will be incorporated into a pilot feasibility study of an SDT based 12-week treatment programme focusing on understanding the lived experience of ADHD and building on these strengths. The treatment will be designed for individual participants and delivered online. This study will have two sets of participants: one group will go directly to treatment, the other will go on a 12-week waiting list to create a comparison group. The second group will then be offered the 12-week treatment. Measures of experience of the participants will be looking for the feasibility, acceptability and efficacy of this treatment, as well as indicators of symptom improvement, and changes in self-awareness and self-regulation skills.

详细描述

ADHD symptoms negatively affect daily functioning both at work and at home, and have long-term impact in academic, occupational, social and emotional areas of functioning. Effective, long-term treatment outcomes benefit both the individual with ADHD and society as undiagnosed and untreated adults with ADHD may become an economic burden due to increased health care costs and decreased productivity at work. Russell Barkley postulated the first unifying theory of ADHD which places a core deficit of behavioural inhibition at the source of ADHD behaviours. Barkley's model is built upon observation of perceived chronic difficulties in behaviour, measured as "excessive or inappropriate for their age or development level.". Since the publication of this model, several theoretical models were proposed which attribute alternative cognitive sources for the development of ADHD symptoms, but Barkley's model forms the foundation for primary treatment recommendations. A recent review of the theories of ADHD recommended that more testable hypotheses need to be produced. While a variety of different interventions are available and the benefit of other forms of support is acknowledged (e.g. psychotherapy or coaching), the National Institute for Health and Care Excellence (NICE) only recommends interventions that match a similar protocol to medications: Randomised Controlled Trials (RCTs), which are primarily based in Cognitive Behavioural Therapy (CBT). It is therefore hypothesised that much of current research for the characterisation of ADHD is based on a cognitive behavioural paradigm that is deficit-focused with primary treatment outcomes of symptom reduction and control of maladaptive behaviours. Research in psychology suggests that a deficit-focus may not be the best approach to improving mental health, and it may be necessary to develop positive psychological factors and emotions that cultivate health and wellbeing. In ADHD, research suggests that this includes cognitive dynamism, creativity, and resilience, among others. There is a paucity of research in this area.

This project proposes an alternative approach to understanding and working with ADHD behaviours, supported by Self Determination Theory (SDT). SDT is an empirical, organismic dialectical approach to human motivation and personality, originating in Positive Psychology. SDT guided research focuses on conditions that enhance intrinsic motivation, self-regulation, and wellbeing. The positive approach to active energisation and intention of behaviour in SDT is closely aligned to evidence of positive engagement in ADHD (e.g. via interest), therefore viewing ADHD behaviours from an SDT perspective allows for a different understanding of the action and intention of behaviour. An SDT based approach combined with psychotherapeutic principles for integration of a positive concept of self provides tools which are potentially effective for long term treatment.

One of the challenges to designing effective treatment is the variability of impairment experienced by individuals with ADHD. Impairments are viewed as "clusters" of chronic difficulty for everyone with an ADHD diagnosis, however individual profiles can differ significantly. This implies there are situations or contexts where individuals with ADHD can function successfully. Two phases of this project have been developed to support this hypothesis. The aim of Phase 2 is to generate a theory, grounded in data, that explains a) why and how individuals with ADHD experience variable impairment; b) the impact of variable impairment for those with ADHD; and c) processes and strategies used by those with ADHD to resolve their main concerns regarding the impact and consequences of the variable impairment of ADHD. The purpose is to identify universal selective strengths that support individuals with ADHD to manage the variability of their impairment. In support of these alternative theories and approaches, Phase 3 of this project aims to examine the participant acceptability, feasibility, and efficacy of a novel strength - based programme of therapeutic self-development, psychoeducation and skills training for adults with a diagnosis of ADHD. This programme will use a multi-modal psychotherapeutic approach and educational methodology to assist participants in understanding ADHD and develop self-management skills.

While ADHD is primarily viewed as a neurobiological disorder with no cure, the possibility that ADHD may confer advantages to the individual is widely debated. Research on phenomena concerning the experience of ADHD has theoretical implications, and grounded theory is presented as a research methodology that is ideal for an area where not much research or theorising has been done before. There are currently several methodological approaches to grounded theory, and for this project it was deemed most appropriate to use a Constructivist approach. This approach introduces a pragmatic epistemological perspective on the researcher by recognising the subjectivity and researcher involvement in construction and interpretation of data in theory construction. This was thought to be an important element to monitor during the research process due to the researcher's own personal experience of ADHD.

In keeping with the focus on selecting cases which may provide new insights for developing theory, this project will aim to approach three different groups for participation: NHS patients from the Adult ADHD Clinic at the Southwest Yorkshire Partnership NHS Foundation Trust; university students at the University of Huddersfield and the University of Cambridge; and ADHD Support Groups for adults with ADHD. Analysis of individual case studies was considered, however as current perspectives of positive psychological factors in ADHD are identified as "individual strengths", it was thought a case comparison on interviews might identify the phenomenon in a more universal way.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of ADHD
  • Age 18 or older
  • Access to computer or smartphone with an internet connection

排除标准

  • Co-morbid diagnosis (e.g. Autism, Bi-polar, Learning Disabilities, Traumatic Brain Injury, Psychosis or Tourette's)
  • Substance abuse disorders
  • Other mental health disorders (e.g. PTSD, Oppositional Defiant Disorder
  • Personality Disorders

结局指标

主要结局

Patient Heath Questionniare (PHQ)- 9

时间窗: Baseline and immediately after intervention

Major Depressive Disorder section of larger PHQ measuring change in severity of Depression symptoms. Minimim score 0, maximum score 27, higher scores mean worse outcome.

Harter's Self Perception Profile

时间窗: Baseline and immediately after intervention

Measures changes in self awareness. Each item has minimum score of 1, maximum score of 4. Mean scores are calculated for each of 12 sub-domains. Higher scores mean better outcome.

Personal Questionnaire - PQ

时间窗: During the intervention

Measure change in participant selected specific psychological difficulties. 10 problems are measured weekly with score of minimum 1, maximum 7. Total is calculated by averaging scores in each subscale, with higher scores meaning a better outcome.

Weiss Functional Impairment Rating Scale -WFIRS

时间窗: Baseline and immediately after intervention

Measures change in severity of ADHD symptoms. Lilkert scale where the total score can be reviewed, or a mean score from each relevant domain. Higher scores mean worse outcome.

General Anxiety Disorder (GAD) 7

时间窗: Baseline and immediately after intervention

Measures change in severity of Anxiety symptoms. Scale score ranges from 0 to 21 with cut points of 5, 10, and 15 that might be interpreted as representing mild, moderate, and severe levels of anxiety. Higher scores mean worse outcome.

Index of Autonomous Functioning -IAF

时间窗: Baseline and immediately after intervention

Measures changes in feeling self-determined. Each item scores minimum 1, maximum 5 and total is calculated by averaging scores from 15 items. Higher scores mean better outcome.

Perceived Choice and Awareness of Self Scale -PCASS

时间窗: Baseline and immediately after intervention

Measures changes in feeling self-determined. Likert 10-item scale, with two 5-item subscales with minimum of 1 and maximum of 5 on each item. Total is calculated by averaging scores in each subscale, with higher scores meaning a better outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Champ

Principal Investigator

University of Huddersfield

研究点 (4)

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