- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06577623
In-Person Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Arizona
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Phoenix, Arizona, United States, 85006
- Southwest Autism Research and Resource Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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 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
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MINDful TIME group
8-week mindfulness-based intervention for adolescents with ASD and their caregivers.
Weekly meetings will be held in-person and will last approximately 2-hours.
Adolescents and their caregivers will be asked to engage in home practice outside of group meetings
|
Group-based psychoeducational mindfulness-based intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change from Baseline in Children's Depression Inventory (CDI) Scores
Time Frame: 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.
|
Post-intervention (8 weeks); 2-month follow-up
|
|
Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores
Time Frame: 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.
|
Post-intervention (8 weeks); 2-month follow-up
|
|
Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores
Time Frame: 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.
|
Post-intervention (8 weeks); 2-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change from Baseline in Beck Youth Inventories (BYI) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up
|
Adolescent-report measure of depression.
Scores range from 0 to 90, with higher scores indicating higher levels of depression.
|
Post-intervention (8 weeks); 2-month follow-up
|
|
Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up
|
Adolescent-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
|
|
Mean Change from Baseline in Adaptive Behavior Assessment System (ABAS-3) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up
|
Parent-report measure of adolescent adaptive skills across the lifespan.
Scores range from 40 to 120, with higher scores indicating better adaptive skills.
|
Post-intervention (8 weeks); 2-month follow-up
|
|
Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores
Time Frame: Post-intervention (8 weeks); 2-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.
|
Post-intervention (8 weeks); 2-month follow-up
|
|
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up
|
Adolescent-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
|
|
Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores
Time Frame: Post-intervention (8 weeks); 2-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.
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Post-intervention (8 weeks); 2-month follow-up
|
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Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up
|
Parent-report measure of adolescent presence and severity of social impairment within autism spectrum.
T-scores range from 30 to > 90 with higher scores indicating greater social impairment.
|
Post-intervention (8 weeks); 2-month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nicole Matthews, Ph.D., Southwest Autism Research & Resource Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00016672b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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