Pilot Randomized Controlled Trial of a Telehealth 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
- 42
- 试验地点
- 2
- 主要终点
- Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores
研究概览
简要总结
This project will evaluate the effectiveness of MINDful TIME, an 8-week mindfulness-based program designed to improve mental health in adolescents with autism spectrum disorder and their caregivers. MINDful TIME includes weekly psychoeducational group meetings conducted through videoconferencing and use of a commercially available mindfulness meditation app. The investigators predict that adolescents in the mindfulness intervention group will demonstrate increases in self-reported mindfulness and reductions in self- and parent-reported anxiety and depression relative to a delayed treatment control group. The investigators will also explore whether caregivers in the treatment group demonstrate improvements in quality of life.
详细描述
Interested individuals and their parent/caregiver who meet preliminary eligibility criteria during the phone screen will be scheduled for a 1-2 hour virtual study visit to complete an intake interview for study and a brief IQ test. If individuals have completed this assessment at SARRC within the last five years, they will not be re-assessed; however, they will complete a 30-minute virtual intake visit to complete the intake interview, learn about the intervention and determine if they would like to participate.
Participants in the treatment group will complete three virtual study visits (Baseline, intervention exit, 2-month follow-up), whereas participants in the delayed treatment control group will complete four virtual study visits (Baseline, wait for the period exit, intervention exit, 2 month-follow-up). After completing their second-time point (i.e., wait period exit) participants in the delayed treatment control group will be enrolled in the 8-week intervention.
The investigators anticipate that the duration of an individual participant's participation in the study from baseline data collection to study completion will be approximately 6 months. Participants may be enrolled up to 8 months prior to their baseline data collection depending on when they are recruited into the study and whether they participate in cohort 1 or cohort 2.
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 the formal diagnostic or educational report)
- •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
- •Participants must live in the state of Arizona, USA
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 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.
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.
次要结局
- 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 Social Responsiveness Scale (SRS-2) 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 Adaptive Behavior Assessment System (ABAS-3) Scores(Post-intervention (8 weeks); 2-month follow-up)
- Mean Change from Baseline in Family Quality of Life Scale (FQOL) Scores(Post-intervention (8 weeks); 2-month follow-up)
- Mean Change from Baseline in Beck Youth Inventories (BYI) 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 Stress Index for Parents of Adolescents (SIPA) Scores(Post-intervention (8 weeks); 2-month follow-up)
研究者
Nicole Matthews, Ph.D.
Director of Research
Southwest Autism Research & Resource Center