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

March 24, 2026 updated by: Nicole Matthews, Ph.D.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Southwest Autism Research & Resource Center
        • Contact:
        • Principal Investigator:
          • Nicole L Matthews, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MINDful TIME Intervention
Behavioral: 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 during and after the 8-week intervention.
Active Comparator: Mindfulness Mobile App
Behavioral: 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.

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; 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.
Post-intervention (8 weeks); 2-month follow-up; 6-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; 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.
Post-intervention (8 weeks); 2-month follow-up; 6-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; 6-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; 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change from Baseline in Center for Epidemiological Studies Depression Scale (CESD-D)
Time Frame: 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.
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
Time Frame: 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.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores
Time Frame: 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.
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
Time Frame: 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.
Post-intervention (8 weeks); 2-month follow-up; 6-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; 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.
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
Time Frame: 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.
Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicole Matthews, Ph.D.

Collaborators

Arizona State University
Southwest Autism Research & Resource Center

Investigators

  • Principal Investigator: Nicole Matthews, Ph.D., Southwest Autism Research & Resource Center
  • Principal Investigator: Blair Braden, Ph.D., Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 24, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00023487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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