Mindfulness-Based Intervention for Teens With Autism Spectrum Disorder and Their Caregivers

NCT05685589 | Completed

• 1 other identifier: 00016672
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This project will evaluate the effectiveness of MINDful TIME, an 8-week mindfulness-based program designed to improve mental health in adolescents with autism spectrum disorder and their caregivers. MINDful TIME includes weekly psychoeducational group meetings conducted through videoconferencing and use of a commercially available mindfulness meditation app. The investigators predict that adolescents in the mindfulness intervention group will demonstrate increases in self-reported mindfulness and reductions in self- and parent-reported anxiety and depression relative to a delayed treatment control group. The investigators will also explore whether caregivers in the treatment group demonstrate improvements in quality of life.

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

• 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

• 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

Secondary Outcomes (8)

• Mean Change from Baseline in Beck Youth Inventories (BYI) Scores

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

• Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores

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

• Mean Change from Baseline in Adaptive Behavior Assessment System (ABAS-3) Scores

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

• Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores

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

• Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores

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

Study Arms (2)

Mindfulness-based Intervention

EXPERIMENTAL

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 Ten Percent Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for at least 10 minutes each day during and after the 8-week intervention.

Behavioral: MINDful TIME

Delayed Treatment Control

NO INTERVENTION

Participants will be instructed to engage in treatment as usual during their 8-week wait period. After their wait period, participants will be enrolled in the mindfulness-based intervention.

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 Ten Percent Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for at least 10 minutes each day during and after the 8-week intervention.

Mindfulness-based Intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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 the formal diagnostic or educational report)
• 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
• Participants must live in the state of Arizona, USA

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 disabilities.
• 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

Sponsors & Collaborators

• Southwest Autism Research & Resource Center: lead
• Arizona State University: collaborator
• Blue Cross Blue Shield of Arizona Foundation for Community and Health Advancement: collaborator

Study Sites (1)

Southwest Autism Research and Resource Center

Phoenix, Arizona, 85006, United States

Location

Related Publications (1)

• Matthews NL, Mitchell MM, Honda H, Malligo A, Boyd S, Pagni BA, Blair Braden B. Pilot randomized controlled trial of MINDful TIME, a novel telehealth mindfulness-based intervention for autistic adolescents and their caregivers. Autism. 2025 Jul;29(7):1864-1882. doi: 10.1177/13623613251328484. Epub 2025 Mar 31.

  PMID: 40160168 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Blair Braden, Ph.D

  Arizona State University

  PRINCIPAL INVESTIGATOR

• Nicole Matthews, Ph.D

  Southwest Autism Research and Resource Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 17, 2023
• Study Start: January 4, 2023
• Primary Completion: January 30, 2024
• Study Completion: April 8, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available upon request starting 6 months after publication and will remain available for 2 years.
• Access Criteria: Data requests should be submitted to Dr. Nicole Matthews at nmatthews@autismcenter.org and must include study aims and purpose and a detailed analysis plan describing how the data will be used. Requests will be reviewed by Dr. Matthews and access to the data will be made available through a secure link to download the requested data.

Locations

US (1)