NCT05685589Completed
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
Source: ClinicalTrials.gov · Last updated 17 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 5 Jan 2023
- Start date
- 4 Jan 2023
- Primary completion date
- 30 Jan 2024
- Lead sponsor
- Southwest Autism Research & Resource Center
- Diseases
- Autism
- NCT number
- NCT05685589
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 4 Jan 2023 to the primary completion date, 30 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- 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 who report active suicidal ideation
Who the study is looking for
- 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
Age in the registry: 13 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Southwest Autism Research and Resource Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.