Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers

Обзор

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

Вмешательства

• Поведенческое MINDful TIME
  The intervention will include weekly 90-minute group meetings held online through Zoom. Adolescents and parents will meet in separate groups and will learn about mindfulness-based strategies that can be used to manage and reduce stress, anxiety, and depression. They will also learn evidence-based strategies to complete daily guided mindfulness meditations using Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for 5-20 minutes each day
• Поведенческое Mindfulness Mobile App
  Participants will receive access to the Happier app and brief instruction in Habit Formation strategies at the start of their intervention period. A trained member of the research team will provide participants instructions for anchoring their mindfulness meditation to a pre-existing habit (i.e., their morning bathroom routine). Like the treatment group, participants will be encouraged to meditate using the mobile app for 5-20 minutes each day during and after the 8-week intervention period.

Первичные конечные точки

• Mean Change from Baseline in Children's Depression Inventory (CDI) Scores [Срок оценки: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up]
• Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores [Срок оценки: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up]
• Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores [Срок оценки: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up]

Вторичные конечные точки (6)

• Mean Change from Baseline in Center for Epidemiological Studies Depression Scale (CESD-D) [Срок оценки: 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 [Срок оценки: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up]
• Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores [Срок оценки: 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 [Срок оценки: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up]
• Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores [Срок оценки: 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 [Срок оценки: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Southwest Autism Research & Resource Center — Phoenix

Идентификаторы

NCT: NCT07501286 · 00023487

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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