Mindfulness-based Intervention for Autism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
AutismMINDful TIME - Behavioral
Eligibility
13 - 18
All Sexes
What conditions do you have?
Select

Study Summary

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. We 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. We will also explore whether caregivers in the treatment group demonstrate improvements in quality of life.

Eligible Conditions
  • Autism

Treatment Effectiveness

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: Post-intervention (8 weeks); 2-month follow-up

Week 8
Mean Change from Baseline in Adaptive Behavior Assessment System (ABAS-3) Scores
Mean Change from Baseline in Beck Youth Inventories (BYI) Scores
Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores
Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores
Mean Change from Baseline in Children's Depression Inventory (CDI) Scores
Mean Change from Baseline in Family Quality of Life Scale (FQOL) Scores
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores
Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores
Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores
Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores
Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores

Trial Safety

Trial Design

2 Treatment Groups

Delayed Treatment Control
1 of 2
Mindfulness-based Intervention
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Mindfulness-based Intervention · No Placebo Group · N/A

Mindfulness-based Intervention
Behavioral
Experimental Group · 1 Intervention: MINDful TIME · Intervention Types: Behavioral
Delayed Treatment ControlNoIntervention Group · 1 Intervention: Delayed Treatment Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: post-intervention (8 weeks); 2-month follow-up

Who is running the clinical trial?

Southwest Autism Research & Resource CenterLead Sponsor
5 Previous Clinical Trials
386 Total Patients Enrolled
Blue Cross Blue Shield of Arizona Foundation for Community and Health AdvancementUNKNOWN
Arizona State UniversityOTHER
244 Previous Clinical Trials
89,050 Total Patients Enrolled
Blair Braden, Ph.DPrincipal InvestigatorArizona State University
Nicole Matthews, Ph.DPrincipal InvestigatorSouthwest Autism Research and Resource Center

Eligibility Criteria

Age 13 - 18 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between 13 and 18 years old to participate.
Your formal ASD diagnosis has been confirmed by the research team through review of your diagnostic or educational records.
You must consent to be randomly assigned to either a treatment or delayed-treatment group.
You must be available to attend a minimum of seven out of the eight group meetings.
To participate, adolescents and their parent/caregivers must possess English language proficiency to comprehend the screening and behavioral measures, as well as understand the intervention content.
You must be a resident of Arizona, United States.