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NCT Number: NCT07501286

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

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

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southwest Autism Research & Resource Center

Phoenix, Arizona, 85006, United States

Location status: Recruiting

Location contact

Nicole L Matthews, Ph.D.

PRINCIPAL_INVESTIGATOR

Nicole Matthews

CONTACT

[email protected]

480-582-9499

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Olivia Melita

CONTACT

[email protected]

(480) 603-3285

Sponsors and collaborators

Lead sponsor

Nicole Matthews, Ph.D.

Other

Collaborators

  • Arizona State University
  • Southwest Autism Research & Resource Center

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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