A Pilot Study of Cognitive Remediation Therapy for Autistic Adolescents
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acceptability 1 - Drop out rate
研究概览
简要总结
Autistic youth have extremely high levels of co-occurring mental health difficulties, including rates of depression and anxiety which are between two and four times more common compered to non-autistic people. Cognitive inflexibility is a characteristic which is strongly associated with higher levels of anxiety and depression in autism. Currently, there are no existing treatments which can promote flexible thinking. Cognitive Remediation Therapy is a promising intervention which has been used with different patient groups to improve flexibility. This study aims to develop and adapt the current CRT treatment for use with autistic youth and then conduct a pilot study with 20 participants.
详细描述
The existing evidence that CRT is effective for those with autistic features leads us to hypothesize that with minor adaptations the intervention will be acceptable to those with autism. Given the strong association between CI and anxiety (and other internalizing difficulties such as depression; ref) by targeting this specific trait it is hypothesized that an adapted CRT will a) increase flexible thinking and b) reduce symptoms of anxiety and depression.
Key objectives:
- To use the existing literature of adapted interventions for autism and input from autistic youth and their parents to adapt CRT for use with autistic youth.
- To establish the acceptability of adapted CRT by conducting a proof-of-principle pilot study.
- To gather preliminary outcome data on CI, anxiety and depression, and other key measures such as levels of functional outcomes to inform the design of an acceptability and feasibility RCT for future funding applications.
Methods:
Participants will all complete 8 adapted CRT intervention sessions held twice weekly. Outcome measures will be collected pre- and post intervention. Measures of acceptability of the intervention (e.g., retention rate) will be recorded and qualitative interviews will gather feedback on the intervention.
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
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-16 years of age with a confirmed clinical diagnosis of autism (based on verified diagnostic report).
- •Verbal/intellectual ability in average range
- •Sufficient spoken English to access the intervention.
- •Young person must be under the care of a local mental health service who can respond to any changes in routine clinical care / risk issues that arise.
排除标准
- •Not currently receiving alternative psychological intervention
- •Not actively self-harming or deemed at risk to themselves or others
结局指标
主要结局
Acceptability 1 - Drop out rate
时间窗: 8 weeks
Number of participants who drop-out from the study
Acceptability 2 - session attendance rate:
时间窗: 8 weeks
total number of sessions attended out of a maximum of 8 per participant
Acceptability 3 - adherence to the therapy protocol
时间窗: 8 weeks
Completion rates of between session work - recorded as percentage.
Acceptability 4 - Semi-structured qualitative interviews post intervention
时间窗: 8 weeks
次要结局
- Cognitive Flexibility Scale(8 weeks)
- DFLEX(8 weeks)
- Revised Child Anxiety and Depression Scale(8 weeks)
- Mood and Feelings Questionnaire(8 weeks)
- Work and Social Adjustment Scale(8 weeks)