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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Nicole Matthews, Ph.D.
Study ID
NCT07501286
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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

Key Dates

Start date
Mar 24, 2026
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MINDful TIME Intervention
  • Active Comparator: Mindfulness Mobile App

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southwest Autism Research & Resource CenterPhoenixArizona85006
Nicole Matthews
[email protected]
480-582-9499
Nicole L Matthews, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Southwest Autism Research & Resource Center· Phoenix, AZ

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