In-Person Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 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
Adolescents with ASD often have co-occurring mental health symptoms like stress, anxiety, and depression. The investigators are conducting this research study to develop interventions for adolescents with ASD that will improve co-occurring mental health symptoms.
详细描述
Adolescents with ASD and their parents will complete a 3-hour in-person screening visit to determine eligibility for the study.
Adolescents with ASD and their caregivers will participate in an 8-week mindfulness-based group intervention that meets once weekly at SARRC in Phoenix, Arizona. Each meeting will last approximately 2-hours. Teens and parents/caregivers will have separate meetings with separate group leaders but will reunite for approximately 15-minutes as a larger group to review home practice for the upcoming week. Teens and parents will each be given a free 1-year subscription to Ten Percent Happier, a commercially available mobile app focused on mindfulness meditations. Each week teens will be assigned home practice, which means we will ask participants to practice mindfulness meditation every day. The investigators will recommend specific meditations and activities to complete, but participants will have access to all mindfulness meditations on the Ten Percent Happier app.
Teens and caregivers will be asked to complete questionnaires assessing things like mood, anxiety, quality of life, mindfulness in day-to-day life, and their perception of the intervention. These questionnaires will be done immediately before the intervention, immediately after completing the intervention, and at 2-month follow-up.
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
- 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 the formal diagnostic or educational report)
- •Must be able to attend at least 7 of the 8 in-person 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 disabilities.
- •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
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
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
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 Beck Youth Inventories (BYI) Scores(Post-intervention (8 weeks); 2-month follow-up)
- Mean Change from Baseline in Adaptive Behavior Assessment System (ABAS-3) Scores(Post-intervention (8 weeks); 2-month follow-up)
- Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores(Post-intervention (8 weeks); 2-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)
- Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores(Post-intervention (8 weeks); 2-month follow-up)
- Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores(Post-intervention (8 weeks); 2-month follow-up)
- Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores(Post-intervention (8 weeks); 2-month follow-up)