Mindfulness Intervention for Autism Spectrum Disorder

Overseen By Nicole Matthews, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Southwest Autism Research & Resource Center

Disqualifiers: Non-verbal, IQ <70, physical disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new mindfulness program called MINDful TIME, designed to help adolescents with Autism Spectrum Disorder (ASD) manage stress, anxiety, and depression. The program includes an 8-week course with weekly in-person group meetings for both adolescents and their caregivers. It suits teens aged 13 to 18 with a confirmed ASD diagnosis who can attend most sessions and are comfortable participating in English. The study aims to provide new ways for these adolescents to improve their mental health. As an unphased trial, it offers a unique opportunity to contribute to innovative mental health solutions for adolescents with ASD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mindfulness-based intervention is safe for adolescents with ASD?

Research has shown that mindfulness programs like MINDful TIME are generally safe for people with Autism Spectrum Disorder (ASD). Studies have found that participants often experience reduced stress and fewer behavioral issues. Past research has reported no serious side effects, suggesting that MINDful TIME could be a safe choice for teenagers with ASD seeking to manage stress, anxiety, and depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

MINDful TIME is unique because it focuses on mindfulness as a tool for adolescents with Autism Spectrum Disorder (ASD) and their caregivers, offering an alternative to traditional behavioral therapies and medication. This 8-week program emphasizes in-person interaction and home practice, promoting active engagement and personal growth. Researchers are excited about this approach because it targets emotional regulation and stress reduction, which are often challenging for individuals with ASD, potentially leading to improved quality of life for both adolescents and their families.

What evidence suggests that this mindfulness intervention is effective for improving mental health symptoms in adolescents with ASD?

Research shows that mindfulness-based programs, such as MINDful TIME, can help people with autism. These programs reduce feelings of distress, anxiety, depression, and stress. They also enhance awareness and focus on the present moment. A small study on MINDful TIME found it effective in teaching mindfulness to teens with autism. Overall, evidence suggests that mindfulness can improve mental health for adolescents with autism spectrum disorder. ^{1 2 3 6 7}

Who Is on the Research Team?

Nicole Matthews, Ph.D

Principal Investigator

Southwest Autism Research & Resource Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adolescents aged 13-18 with a formal ASD diagnosis and their caregivers. Participants must commit to attending at least 7 of the 8 group meetings.

Inclusion Criteria

My autism diagnosis has been confirmed by the study team.

I can attend at least 7 out of 8 group meetings.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

8-week mindfulness-based group intervention for adolescents with ASD and their caregivers, including weekly 2-hour in-person meetings and daily home practice

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in mental health symptoms and mindfulness at 2-month follow-up

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MINDful TIME

Trial Overview The study tests 'MINDful TIME,' an intervention aimed at improving mental health symptoms like stress, anxiety, and depression in adolescents with Autism Spectrum Disorder (ASD).

How Is the Trial Designed?

Group I: MINDful TIME group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Southwest Autism Research & Resource Center

Lead Sponsor

Trials

9

Recruited

950+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Published Research Related to This Trial

Mindfulness-based interventions show promising potential for improving anxiety, social skills, and aggressive behaviors in children and young people with Autism Spectrum Disorder (ASD), based on a systematic review of 23 studies.

However, the overall quality of the studies was weak, with over half being rated as having methodological weaknesses, which suggests that results should be interpreted cautiously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of mindfulness-based therapy for anxiety, social skills, and aggressive behaviors in children and young people with Autism Spectrum Disorder: A systematic review. Loftus, T., Mathersul, DC., Ooi, M., et al.[2023]

Mindfulness-based therapies show promise in improving outcomes for adults with autism spectrum disorder (ASD), but more research is needed to understand the specific components that contribute to their effectiveness.

Future studies should focus on the duration of benefits, the psychological and neural mechanisms behind the changes observed, and the overall breadth of impact these therapies have on individuals with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Reflections on the Therapeutic Effects of Mindfulness-Based Therapies in Adults with Autism and Suggestions for Future Research. Pagni, BA., Braden, BB.[2021]

A virtual group-based mindfulness intervention designed specifically for autistic adults was found to be feasible and well-accepted, with 37 participants completing a six-week course and providing positive feedback on the experience.

Participants reported significant reductions in psychological distress and improvements in mindfulness and self-compassion, with these benefits maintained at a three-month follow-up, indicating the potential effectiveness of adapted mindfulness practices for this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Group-Based Mindfulness Intervention for Autistic Adults: a Feasibility Study. Lunsky, Y., Redquest, B., Albaum, C., et al.[2022]

An eight-week school-based mindfulness program significantly improved inhibition and selective attention in children with autism spectrum disorder (ASD), with 27 participants involved in the study.

The intervention led to medium effect sizes for prepotent response inhibition and interference control, and a large effect size for overall selective attention, suggesting mindfulness can enhance executive functioning in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a school-based mindfulness program for improving inhibitory skills in children with autism spectrum disorder. Juliano, AC., Alexander, AO., DeLuca, J., et al.[2021]

Both Therapeutic Riding (THR) and HeartMath (HM) mindfulness interventions effectively reduced cortisol levels immediately after sessions in adolescents with autism spectrum disorder, based on a study involving 27 participants over three 10-week periods.

HeartMath showed a greater impact on heart-rate variability compared to Therapeutic Riding, while THR was more effective in reducing certain self-reported stress levels, indicating that both interventions have unique benefits for managing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Riding or Mindfulness: Comparative Effectiveness of Two Recreational Therapy Interventions for Adolescents with Autism. Kemeny, B., Burk, S., Hutchins, D., et al.[2023]

In a pilot study involving 61 parents of children with autism spectrum disorder, both parent-implemented Early Start Denver Model (P-ESDM) and P-ESDM plus mindfulness-based stress reduction (MBSR) led to significant improvements in parent stress, depressive symptoms, and anxiety during treatment.

Parents who participated in the MBSR program experienced greater reductions in parental distress and dysfunctional interactions with their children compared to those who only received P-ESDM, highlighting the potential benefits of integrating mindfulness strategies into interventions for parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Parents Implementing Early Intervention for Autism: An RCT. Weitlauf, AS., Broderick, N., Stainbrook, JA., et al.[2023]

The MYmind mindfulness program showed high feasibility in a study with Chinese adolescents with autism spectrum disorder, achieving an 80% compliance rate and 0% dropout rate, indicating strong participant engagement.

Preliminary results suggested that the program positively impacted parents' mental health, with notable trends in reducing rumination and parenting stress, highlighting its potential benefits for families affected by autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Mindfulness Training for Chinese Adolescents with Autism Spectrum Disorder and Their Parents in Hong Kong. Ho, RYF., Zhang, D., Chan, SKC., et al.[2022]

In a 16-week mindfulness-based treatment study involving 37 adolescents and young adults with autism spectrum disorder (ASD), the therapeutic alliance was found to fluctuate over time, indicating that the relationship between the therapist and client can change during treatment.

A stronger therapeutic alliance was associated with better emotion regulation outcomes, specifically reduced dysphoria after treatment, suggesting that building a strong connection with clients is crucial for effective therapy in individuals with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Alliance Formation for Adolescents and Young Adults with Autism: Relation to Treatment Outcomes and Client Characteristics. Brewe, AM., Mazefsky, CA., White, SW.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11506216/

Mindfulness-Based Interventions for People with Autism ... Conclusions: The review reveals a positive outcome, including the alleviation of psychological distress, reduced behavioral problems, and enhanced cognitive and ...

2. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2025.1526001/full

The effectiveness of mindfulness-based interventions for ... This meta-analysis demonstrates that MBIs significantly reduce parental stress, alleviate anxiety, depression, and stress, and enhance mindfulness awareness in ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/13623613251328484

Pilot randomized controlled trial of MINDful TIME, a novel ... This is an acceptable program for teaching mindfulness-based strategies to teens with autism spectrum disorder. 6.74 (0.45), 6.78 (0.44), 6.70 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06975163

Effectiveness of Mindfulness-Based Intervention in ... Study Overview. Brief Summary. Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental condition that usually becomes apparent in early childhood.

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0291168

A protocol of randomized control trial of ecological momentary ... This study proposes to conduct a randomized controlled trial (RCT) to examine the effectiveness of MBI delivered by ecological momentary intervention (EMI)

6. digitalcommons.library.uab.edu digitalcommons.library.uab.edu/cgi/viewcontent.cgi?article=1830&context=etd-collection

Using a Mindfulness-Based Intervention with Children with ... This study focused on early childhood inclusion classrooms that include children with characteristics and/or a clinical diagnosis of autism spectrum disorder ( ...

7. asatonline.org asatonline.org/for-parents/becoming-a-savvy-consumer/is-there-science-behind-that-autism-and-treatment-with-mindfulness/

Mindfulness: Is there science behind that? This article reviewed the existing literature to determine whether there is a sufficient evidence base to support the use of mindfulness with autistic ...