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

Pilot Randomized Controlled Trial of a Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: MINDful TIME

Detailed Description

Interested individuals and their parent/caregiver who meet preliminary eligibility criteria during the phone screen will be scheduled for a 1-2 hour virtual study visit to complete an intake interview for study and a brief IQ test. If individuals have completed this assessment at SARRC within the last five years, they will not be re-assessed; however, they will complete a 30-minute virtual intake visit to complete the intake interview, learn about the intervention and determine if they would like to participate.

Participants in the treatment group will complete three virtual study visits (Baseline, intervention exit, 2-month follow-up), whereas participants in the delayed treatment control group will complete four virtual study visits (Baseline, wait for the period exit, intervention exit, 2 month-follow-up). After completing their second-time point (i.e., wait period exit) participants in the delayed treatment control group will be enrolled in the 8-week intervention.

The investigators anticipate that the duration of an individual participant's participation in the study from baseline data collection to study completion will be approximately 6 months. Participants may be enrolled up to 8 months prior to their baseline data collection depending on when they are recruited into the study and whether they participate in cohort 1 or cohort 2.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Southwest Autism Research and Resource Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 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

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based Intervention; 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; 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.
No Intervention: Delayed Treatment Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores	Parent-report measure of adolescent presence and severity of social impairment within autism spectrum.	Post-intervention (8 weeks); 2-month follow-up
Mean Change from Baseline in Beck Youth Inventories (BYI) Scores	Adolescent-report measure of depression. Scores range from 0 to 90, with higher scores indicating higher levels of depression.	Post-intervention (8 weeks); 2-month follow-up
Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores	Adolescent-report measure on current well-being. Scores range from 0 to 100, with higher scores indicating better quality of life.	Post-intervention (8 weeks); 2-month follow-up
Mean Change from Baseline in Adaptive Behavior Assessment System (ABAS-3) Scores	Parent-report measure of adolescent adaptive skills across the lifespan. Scores range from 40 to 120, with higher scores indicating better adaptive skills.	Post-intervention (8 weeks); 2-month follow-up
Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores	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.	Post-intervention (8 weeks); 2-month follow-up
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores	Adolescent-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.	Post-intervention (8 weeks); 2-month follow-up
Mean Change from Baseline in Family Quality of Life Scale (FQOL) Scores	Parent-report measure of family quality of life in family interaction, parenting, emotional well-being, physical/material well-being, and disability-related support. Scores range from 1 to 5, with higher scores indicating higher satisfaction with family quality of life.	Post-intervention (8 weeks); 2-month follow-up
Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores	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.	Post-intervention (8 weeks); 2-month follow-up

Collaborators and Investigators

• Sponsor: Southwest Autism Research & Resource Center
• Collaborators: Arizona State University; Blue Cross Blue Shield of Arizona Foundation for Community and Health Advancement
• Investigators: Principal Investigator: Blair Braden, Ph.D, Arizona State University; Principal Investigator: Nicole Matthews, Ph.D, Southwest Autism Research and Resource Center

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): April 8, 2024

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 00016672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.
• IPD Sharing Time Frame: Data will be available upon request starting 6 months after publication and will remain available for 2 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No