Recruiting

MINDful TIME

Sponsor:

Nicole Matthews, Ph.D.

Code:

NCT07501286

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

MINDful TIME

Mindfulness Mobile App

Study Details

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

Conditions

Autism Spectrum Disorder

Study ID

NCT07501286

Start date

Mar 24, 2026

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MINDful TIME Intervention

active comparator: Mindfulness Mobile App

Interventions

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.

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.

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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Olivia Melita

(480) 603-3285omelita@autismcenter.org

Locations

Southwest Autism Research & Resource Center

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Nicole Matthews

480-582-9499nmatthews@autismcenter.org

Principal Investigator:

Nicole L Matthews, Ph.D.

More Information

Sponsor

Nicole Matthews, Ph.D.

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nicole Matthews, Ph.D. on 2026-03-30.