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

Adolescents with ASD often have co-occurring mental health symptoms like stress, anxiety, and depression. The investigators are conducting this research study to develop interventions for adolescents with ASD that will improve co-occurring mental health symptoms.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Adolescents with ASD and their parents will complete a 3-hour in-person screening visit to determine eligibility for the study.

Adolescents with ASD and their caregivers will participate in an 8-week mindfulness-based group intervention that meets once weekly at SARRC in Phoenix, Arizona. Each meeting will last approximately 2-hours. Teens and parents/caregivers will have separate meetings with separate group leaders but will reunite for approximately 15-minutes as a larger group to review home practice for the upcoming week. Teens and parents will each be given a free 1-year subscription to Ten Percent Happier, a commercially available mobile app focused on mindfulness meditations. Each week teens will be assigned home practice, which means we will ask participants to practice mindfulness meditation every day. The investigators will recommend specific meditations and activities to complete, but participants will have access to all mindfulness meditations on the Ten Percent Happier app.

Teens and caregivers will be asked to complete questionnaires assessing things like mood, anxiety, quality of life, mindfulness in day-to-day life, and their perception of the intervention. These questionnaires will be done immediately before the intervention, immediately after completing the intervention, and at 2-month follow-up.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • 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 able to attend at least 7 of the 8 in-person 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 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MINDful TIME group
8-week mindfulness-based intervention for adolescents with ASD and their caregivers. Weekly meetings will be held in-person and will last approximately 2-hours. Adolescents and their caregivers will be asked to engage in home practice outside of group meetings
Group-based psychoeducational 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
Time Frame: Post-intervention (8 weeks); 2-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.
Post-intervention (8 weeks); 2-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
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
Time Frame: Post-intervention (8 weeks); 2-month follow-up
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 Beck Youth Inventories (BYI) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up
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
Time Frame: Post-intervention (8 weeks); 2-month follow-up
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
Time Frame: Post-intervention (8 weeks); 2-month follow-up
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
Time Frame: Post-intervention (8 weeks); 2-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.
Post-intervention (8 weeks); 2-month follow-up
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up
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 Stress Index for Parents of Adolescents (SIPA) Scores
Time Frame: Post-intervention (8 weeks); 2-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.
Post-intervention (8 weeks); 2-month follow-up
Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores
Time Frame: Post-intervention (8 weeks); 2-month follow-up
Parent-report measure of adolescent presence and severity of social impairment within autism spectrum. T-scores range from 30 to > 90 with higher scores indicating greater social impairment.
Post-intervention (8 weeks); 2-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Nicole Matthews, Ph.D., Southwest Autism Research & Resource Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2024

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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