NCT07501286

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Feb 2028

First Submitted

Initial submission to the registry

March 24, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

  • Mean Change from Baseline in Children's Depression Inventory (CDI) Scores

    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

    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

    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 Outcomes (6)

  • 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

  • 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

  • Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores

    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

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

  • Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores

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

  • +1 more secondary outcomes

Study Arms (2)

MINDful TIME Intervention

EXPERIMENTAL
Behavioral: MINDful TIME

Mindfulness Mobile App

ACTIVE COMPARATOR
Behavioral: Mindfulness Mobile App

Interventions

MINDful TIMEBEHAVIORAL

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.

MINDful TIME Intervention
Mindfulness Mobile AppBEHAVIORAL

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.

Mindfulness Mobile App

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Autism Research & Resource Center

Phoenix, Arizona, 85006, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nicole Matthews, Ph.D.

    Southwest Autism Research & Resource Center

    PRINCIPAL INVESTIGATOR

  • Blair Braden, Ph.D.

    Arizona State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Melita

CONTACT

(480) 603-3285omelita@autismcenter.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

March 24, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

US(1)