Skip to main content
OpenTrials
Completed

NCT Number: NCT06577623

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Autism Autistic 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 and Resource Center

Phoenix, Arizona, 85006, United States

About this study

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.

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 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

Treatment and study plan

MINDful TIME

Behavioral

Group-based psychoeducational mindfulness-based intervention.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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 &gt; 90 with higher scores indicating greater social impairment.

Sponsors and collaborators

Lead sponsor

Southwest Autism Research & Resource Center

Other

Collaborators

  • Arizona State University

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.