Autism Spectrum Disorder
Conditions
Brief summary
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
Interventions
BEHAVIORALMINDful 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 during and after the 8-week intervention.
BEHAVIORALMindfulness 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.
Sponsors
Nicole Matthews, Ph.D.
Southwest Autism Research & Resource Center
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change from Baseline in Children's Depression Inventory (CDI) Scores | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Adolescent-report measure of depression. 20-item scale with scores ranging from 0 to 60. Higher scores indicate higher depression symptoms. |
| 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 | 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. |
| Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores | Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up | 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. |
| 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 | 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. |
| Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores | Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up | Adolescent-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 World Health Organization-Five Wellbeing Index (WHO-5) Scores | Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up | Parent self-report measure on current well-being. Scores range from 0 to 100, with higher scores indicating better quality of life. |
Countries
United States
Contacts
CONTACTOlivia Melita
PRINCIPAL_INVESTIGATORNicole Matthews, Ph.D.
Southwest Autism Research & Resource Center
PRINCIPAL_INVESTIGATORBlair Braden, Ph.D.
Arizona State University
Outcome results
None listed