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

Phase

N/A

Condition

Williams Syndrome

Asperger's Disorder

Autism

Treatment

MINDful TIME

Clinical Study ID

NCT05685589

00016672

Ages 13-18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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-speakingbecause the screening and behavioral measures are in English, as well as theintervention content
Participants must live in the state of Arizona, USA

Exclusion

Exclusion Criteria:

Non-verbal participants will be excluded to ensure test compliance and increasesample homogeneity.
Participants with IQ scores <70 will be excluded because the intervention wasdeveloped for individuals without intellectual disabilities.
Participants with a physical disability or co-occurring condition that may preventparticipation in the weekly group meetings (e.g., selective mutism; aggressivebehavior; inability to participate in a 90-minute video conference meeting eachweek)
Participants who report active suicidal ideation

Study Design

MINDful TIME

January 04, 2023

April 08, 2024

Study 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.

Connect with a study center

Southwest Autism Research and Resource Center
Phoenix, Arizona 85006
United States
Site Not Available

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