Can Metacognitive Therapy be Used to Treat Common Mental Health Problems in Autistic Children and Adolescents: A Systematic Case Series
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in The Revised Children's Anxiety and Depression Scale (RCADS-25) Score
研究概览
简要总结
Anxiety and Depression are common in young people (CYP) and especially in CYP with a diagnosis of Autism. Autistic people often say therapy has not been adapted to meet their needs. A recent treatment called metacognitive therapy (MCT) is proving to be helpful, but the investigators do not know how autistic CYP will find MCT, or what changes to the delivery of therapy may be needed to meet their needs. This study hopes to explore whether MCT can help treat anxiety and/or depression in autistic young people.
This study aims to offer five autistic CYP MCT. To take part, they must be between 11-16 years old and have depression and/or anxiety symptoms. The study will involve completing questionnaires at the start, during therapy, at the end and after 6 months. Therapy will be scheduled for at least eight sessions. Therapy involves working on what we think about our worry, rather than on specific worries. What we think about our worry can be positive or negative. For example, 'worrying helps me cope' and 'worrying could make me go mad'. This can affect where our attention goes and how we think. At the end of therapy, participants will be asked to take part in an interview about how they found the therapy.
The questionnaires will help test how useful the measures are, suggest how helpful the therapy might be and whether benefits continue after the therapy has ended. Information will also be gathered through a post treatment interview about how the young people found the therapy. This will help understand whether any changes to the therapy are needed to meet the needs of autistic people. This information is necessary for planning a large-scale trial for autistic CYP. Such studies may improve treatment options and service provision for mental health problems in this population.
Primary Question:
• Is MCT a feasible and acceptable treatment for treating anxiety and depression in autistic CYP?
Secondary Questions:
- Is MCT associated with clinically significant change in outcome measures following the introduction of treatment for autistic CYP?
- Are improvements associated with MCT maintained at 6 month follow up?
- Are improvements associated with MCT replicable across autistic CYP?
- Do the investigators need to modify how MCT is delivered to autistic CYP?
详细描述
This study is a systematic replication case series utilising an AB design with follow up to deliver MCT to autistic CYP who experience symptoms of anxiety and/or depression. Allocation to baseline lengths will not be randomised, natural baselines will be utilised whereby participants complete the primary outcome measure weekly until they demonstrate stability. Stability will be defined as an absence of decreasing trend of at least three consecutive data points prior to the introduction of treatment.
Recruitment:
Participants will be identified by CAMHS clinicians during routine clinical practice. Potential participants will be provided with information about the study, including the participant information sheet. Those who are identified as eligible and are interested in taking part or finding out more about the study will consent to their details being shared with the researcher. The details will be securely sent to the researcher using the eligibility form. The researcher will then contact potential participants to confirm whether the like to participate and answer any questions they have about the study.
Screening:
Those who wish to participate will then be invited to attend a screening appointment with the researcher. Written consent will be obtained from participants (and parents/guardians where appropriate). Once consent has been obtained, demographic information, baseline measures will be administered.
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
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 11-16 years
- •Consent given
- •Formal diagnosis of Autism Spectrum Disorder
- •Fluent in English
- •Seeking treatment for emotional disorder symptoms (i.e., generalised anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety; and/or depression)
- •Medication for mental health problems permitted but participants must be stabilised for 6 weeks
排除标准
- •Presence of significant risk or safeguarding concerns
- •Head injury/organic impairment
- •Attention Deficit Hyperactivity Disorder (formal diagnosis or under assessment)
- •Eating Disorder
结局指标
主要结局
Change in The Revised Children's Anxiety and Depression Scale (RCADS-25) Score
时间窗: Baseline period: baseline time one to end of baseline, 4-6 weeks post baseline; end of treatment:12-16 weeks post-baseline one; and 6 month follow up.
A 25-item screening measure designed to assess anxiety and depressive disorders in CYP aged 8-18. Anxiety (15 items; maximum score 45) and depression (10 items; maximum score = 30). In response to each item, participants must select the appropriate response from 'Always' (score = 3), 'Often' (score = 2), 'Sometimes' (score = 1), 'Never' (score = 0). Total minimum score = 0. Total maximum score = 75. Higher scores indicate worse outcomes.
Change in Personal Rating Scale Score
时间窗: Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)
A personal rating scale developed by the researchers, to be administered weekly measuring how distressing the problem has been and how much the problem has interfered with day to day life
Post Intervention Interview
时间窗: 12-16 weeks post baseline (dependent on whether sessions are extended in response to participant needs)
A semi structured interview focusing on perceived benefits and challenges of the therapy, as well as specific aspects of the therapy such as the outcome measures or intervention techniques.
Measure of Credibility and Expectancy
时间窗: Intervention session 1 (3-6 weeks after 1st baseline measure, dependant on length of baseline)
A 3 item measure developed by the researchers measuring expectancy and credibility on a 10 point scale
Measure of Adherence and User Friendliness
时间窗: Final intervention session (12-16 weeks post baseline dependent on whether sessions are extended in response to participant needs)
A 5 item measure developed by the researchers to measure adherence and user friendliness on a 10 point scale
次要结局
- Change in The Youth Cognitive Attentional Syndrome-1 (YoCAS-1) Score(Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up))
- Change in Metacognitions Questionnaire - Adolescent version (MCQ-A) Score(Baseline period: baseline time one and at end of baseline, 4-6 weeks post baseline; end of treatment: at 12-16 weeks post-baseline one; and 6 month follow up.)
- Change in Child Health Utility -9D (CHU-9D) Score(Baseline period: baseline time one and at end of baseline, 4-6 weeks post baseline; end of treatment: at 12-16 weeks post-baseline one; and 6 month follow up.)
研究者
Adrian Wells
Professor
University of Manchester