Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline in Children's Depression Inventory (CDI) Scores
研究概览
简要总结
The goal of this clinical trial is to learn whether a mindfulness-based intervention can reduce depression and anxiety in autistic adolescents. The main question this trial aims to answer is: Do adolescents who complete MINDful TIME show reductions in depression and anxiety compared to an active control group? Researchers will compare adolescents who complete MINDful TIME to adolescents who are instructed to use a mindfulness meditation mobile-app to see if changes in anxiety and depression differ between the two groups.
Participants will either:
- Attend weekly 90-minute MINDful TIME group meetings through Zoom with their parent or caregiver for a total of 8-weeks and use a mindfulness meditation app daily, or
- Use a mindfulness meditation app daily for 8-weeks
All participants will:
- Attend virtual intake, baseline, and follow-up visits to complete data collection
- Complete a weekly electronic meditation diary
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
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents must be ages 13 to 18 years
- •Formal clinical or educational ASD diagnosis confirmed by the study team (i.e., review of formal diagnostic report from the diagnosing practitioner or Multidisciplinary Evaluation Team report (MET) shared with the research team by the family) )
- •Must be willing to be randomized to a treatment or delayed treatment control group
- •Must be able to attend at least 7 of the 8 group meetings
- •English speaking: Adolescents and their parent/caregivers must be English-speaking because the screening and behavioral measures are in English, as well as the intervention content
排除标准
- •Non-verbal participants will be excluded to ensure test compliance and increase sample homogeneity.
- •Participants with IQ scores <70 will be excluded because the intervention was developed for individuals without intellectual disability.
- •Participants with a physical disability or co-occurring condition that may prevent participation in the weekly group meetings (e.g., selective mutism; aggressive behavior; inability to participate in a 90-minute video conference meeting each week)
- •Participants who report active suicidal ideation
结局指标
主要结局
Mean Change from Baseline in Children's Depression Inventory (CDI) Scores
时间窗: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Parent-report measure of adolescent depressive symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of depression symptoms.
Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores
时间窗: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Parent-report measure of adolescent anxiety symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of anxiety symptoms.
Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores
时间窗: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Adolescent-report measure of mindfulness. Scores range from 0 to 40 with higher scores indicating higher levels of mindfulness.
次要结局
- Mean Change from Baseline in Center for Epidemiological Studies Depression Scale (CESD-D)(Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up)
- Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores(Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up)
- Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores(Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up)
- Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores(Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up)
- Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores(Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up)
- Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores(Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up)
研究者
Nicole Matthews, Ph.D.
Director of Research
Southwest Autism Research & Resource Center