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| Name | Class |
|---|---|
| Southwest Autism Research & Resource Center | OTHER |
| Arizona State University | OTHER |
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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:
All participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINDful TIME Intervention | Experimental |
| |
| Mindfulness Mobile App | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINDful TIME | Behavioral | 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 during and after the 8-week intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Children's Depression Inventory (CDI) Scores | Parent-report measure of adolescent depressive symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of depression symptoms. | Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up |
| Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores | Parent-report measure of adolescent anxiety symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of anxiety symptoms. | Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up |
| Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores | Adolescent-report measure of mindfulness. Scores range from 0 to 40 with higher scores indicating higher levels of mindfulness. | Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Center for Epidemiological Studies Depression Scale (CESD-D) | Adolescent-report measure of depression. 20-item scale with scores ranging from 0 to 60. Higher scores indicate higher depression symptoms. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivia Melita | Contact | (480) 603-3285 | omelita@autismcenter.org |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Matthews, Ph.D. | Southwest Autism Research & Resource Center | Principal Investigator |
| Blair Braden, Ph.D. | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Autism Research & Resource Center | Recruiting | Phoenix | Arizona | 85006 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Mindfulness Mobile App | Behavioral | 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. |
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Parent-report measure of adolescent executive function and self-regulation. Scores range from 30 to 90, with higher scores indicating higher levels of executive dysfunction. |
| Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up |
| Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores | Parent self-report measure of mindfulness on observation, description, aware actions, non-judgmental inner experience, and non-reactivity. Factor scores range from 1 to 5, with higher scores indicating higher levels of mindfulness. | 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 | Parent-report measure of the relationship of parenting stress to adolescent characteristics, parent characteristics, the quality of the adolescent-parent interactions, and stressful life circumstances. Percentile scores range from 0 to 99, with higher scores indicating higher levels of parenting stress. | Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up |
| Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores | Adolescent-report measure of adolescent anxiety symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of anxiety symptoms. | 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 | Parent self-report measure on current well-being. Scores range from 0 to 100, with higher scores indicating better quality of life. | Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up |