Treatment of Anxiety in Late Adolescents With Autism
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change from Baseline in anxiety severity on the Hamilton Anxiety Scale after 16 weeks of treatment.
研究概览
简要总结
Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety disorders affect many higher-functioning adolescents and young adults with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders among typically developing late adolescents, and work by the investigative team supports its utility in children with ASD and comorbid anxiety, very few evidence-based treatment approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the investigators are proposing to develop a CBT protocol for clinical anxiety that is personalized to the unique clinical characteristics of late adolescents (ages 16-21 years) with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA).
详细描述
Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety disorders affect many higher-functioning adolescents and young adults with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders among typically developing late adolescents, and work by the investigative team supports its utility in children with ASD and comorbid anxiety, very few evidence-based treatment approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the investigators are proposing to develop a CBT protocol for clinical anxiety that is personalized to the unique clinical characteristics of late adolescents (ages 16-21 years) with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA). Initial TALAA development efforts will focus on adapting relevant treatment elements from an efficacious CBT program for early adolescents with ASD and comorbid anxiety to the characteristics and clinical needs of the age group. Developmentally appropriate, novel treatment components will be added, including those focusing on fostering successful transitions to adulthood (e.g., work readiness). In response to the NIH Roadmap Initiative, attention will be paid to protocol adaptability with varying clinical presentations. Measures of treatment integrity and competence will be developed. Thereafter, protocol and measure development will be refined through our experiences treating 8 young adults (ages 16-21 years) with ASD and comorbid anxiety disorder(s) as well as through clinician, patient, and expert feedback. The feasibility of implementing TALAA will then be examined in the context of a pilot study incorporating all the features of the planned future efficacy trial comparing TALAA to treatment as usual, but with a limited sample size (N=44).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient males and females with ASD between the ages 16-21 years at consent/assent.
- •The individual meets criteria for ASD.
- •The individual meets criteria for clinically significant anxiety symptoms.
- •Meets criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), specific phobia, panic disorder (PD), generalized anxiety disorder (GAD), social phobia (SP), or obsessive compulsive disorder (OCD) and has a minimum score of 14 on the Hamilton Anxiety Scale.
- •Person has a Full Scale IQ approximation > 70 as assessed by the Wechsler Abbreviated Scale for Intelligence-II two or four sub-test form.
排除标准
- •Receiving concurrent psychotherapy focused on anxiety.
- •Initiation of an antidepressant medication within 12 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 8 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects).
- •(a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
- •Lifetime bipolar disorder, schizophrenia or schizoaffective disorder, or substance abuse in past 6 months.
结局指标
主要结局
Change from Baseline in anxiety severity on the Hamilton Anxiety Scale after 16 weeks of treatment.
时间窗: After 16 weeks of treatment
This measure is administered by a clinician and assesses anxiety with scores between 0-30. Higher ratings correspond to more severe anxiety symptoms.
次要结局
- Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment.(After 16 weeks of treatment)