NCT05685589

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

Pilot Randomized Controlled Trial of a Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Southwest Autism Research & Resource Center · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2023-01-04
• Primary completion: 2024-01-30
• Completion: 2024-04-08
• First posted: 2023-01-17
• Last updated: 2024-07-17

Locations

1 site across 1 country: United States