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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-04

Study Completion Date

2024-04-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MINDful TIME

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No