In-Person Mindfulness-based Intervention for Adolescents 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-14

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05685589

Autism Spectrum Disorder

COMPLETED NA

Mindfulness-Associated Brain Changes in Adults With Autism

NCT04017793

Autism Spectrum Disorder

COMPLETED NA

Mindfulness Intervention for Parents of Children With ASD

NCT05746468

Mindfulness

NOT_YET_RECRUITING NA

Smartphone Mindfulness Autism Research Study

NCT05880498

Anxiety Stress

COMPLETED NA

Online Mindfulness-based Program for Parents of Children With Autism

NCT05913869

Mindfulness Psychophysiologic Reaction Behavior, Health

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Adolescents with ASD and their parents will complete a 3-hour in-person screening visit to determine eligibility for the study.

Adolescents with ASD and their caregivers will participate in an 8-week mindfulness-based group intervention that meets once weekly at SARRC in Phoenix, Arizona. Each meeting will last approximately 2-hours. Teens and parents/caregivers will have separate meetings with separate group leaders but will reunite for approximately 15-minutes as a larger group to review home practice for the upcoming week. Teens and parents will each be given a free 1-year subscription to Ten Percent Happier, a commercially available mobile app focused on mindfulness meditations. Each week teens will be assigned home practice, which means we will ask participants to practice mindfulness meditation every day. The investigators will recommend specific meditations and activities to complete, but participants will have access to all mindfulness meditations on the Ten Percent Happier app.

Teens and caregivers will be asked to complete questionnaires assessing things like mood, anxiety, quality of life, mindfulness in day-to-day life, and their perception of the intervention. These questionnaires will be done immediately before the intervention, immediately after completing the intervention, and at 2-month follow-up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder Autism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label feasibility and acceptability trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MINDful TIME group

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

Group Type EXPERIMENTAL

MINDful TIME

Intervention Type BEHAVIORAL

Group-based psychoeducational mindfulness-based intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MINDful TIME

Group-based psychoeducational mindfulness-based intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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

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