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

NCT06577623 | Completed

• 1 other identifier: 00016672b
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism; 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 (7)

• 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 Behavior Rating Inventory of Executive Function (BRIEF) Scores

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

• Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores

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

Study Arms (1)

MINDful TIME group

EXPERIMENTAL

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

Behavioral: MINDful TIME

Interventions

MINDful TIME BEHAVIORAL

Group-based psychoeducational mindfulness-based intervention.

MINDful TIME group

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 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

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

Study Sites (1)

Southwest Autism Research and Resource Center

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nicole Matthews, Ph.D.

  Southwest Autism Research & Resource Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label feasibility and acceptability trial.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: August 14, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)