An interventional study of App-based Mindfulness Intervention in Stress and Anxiety, sponsored by MaineHealth. Suspended at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by MaineHealth · Not applicable, Interventional, and Treatment
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Among 603 studies in Autistic Disorder with a site in United States — 123 open to participants now, 152 under way, 3 of them phase 3. Autistic Disorder · United States.
Among the 603 studies in Autistic Disorder with a site in United States, this one is the 267th largest by planned enrollment of the 504 interventional ones that give a count, is one of 31 that started in 2024, is one of 295 with no phase, and was the 490th registered.
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
Browse Autistic Disorder studies →123 of the 603 studies in Autistic Disorder with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
Ages 8–12
Vanderbilt University Medical Center · Sites in United States
Ages 36 mo–72 mo
University of Wisconsin, Madison · Sites in United States
Massachusetts General Hospital · Sites in United States
Ages 7–17
Stony Brook University · Sites in United States
Ages 12–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 183 Autistic Disorder studies recruiting now, 33 (18%) set no upper age limit and 143 (78%) stop at 75 or younger; 148 take children under 18; 56 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
603 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 55 · Phase 2 122 · Phase 3 43 · Phase 4 18
First in 1997; this study’s year is marked. 31 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 49 across 813 interventional studies indexed under Autistic Disorder.
Median enrollment 44 across the 504 interventional studies, 135 across the 96 observational. Of the 408 that completed or were terminated, 143 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
73 of 603 have an industry lead sponsor. The 10 most frequent:
MaineHealth is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
MaineHealth has 1 study filed under Autistic Disorder — fewer than ten, so there is no comparison to draw.
34 of the studies in Autistic Disorder with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02914951Yale UniversityCognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability | 2026-12 |
| NCT06627205Stanford UniversitySleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism | 2026-12 |
| NCT04805957Rutgers, The State University of New JerseyValidation Digital Bio-markers During Sulforaphane Treatment. | 2026-12-01 |
| NCT07421830Northeastern UniversityAn Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism | 2026-12-31 |
| NCT02000284University of ArkansasMitochondrial Dysfunction in Autism Spectrum Disorder | 2026-12-31 |
Add all 34 to your calendar (.ics) → With an account.
Among the 603 studies in Autistic Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this clinical trial is to investigate the effectiveness of a mobile app-based mindfulness program in improving the mental well-being of caregivers with a child diagnosed with autism spectrum disorder (ASD) who live in rural areas of Maine. The primary question the investigators aim to answer is whether this mindfulness intervention can reduce stress and anxiety in these rural caregivers of children with ASD. Participants in the trial will engage in a 30-day mindfulness program that they can complete over a maximum of 60 days. During this time, they will practice short daily mindfulness lessons and respond to a set of brief questions regarding their anxiety levels. Ultimately, the investigators want to assess whether this intervention helps these caregivers feel less stressed and anxious.
Caregivers of children with autism spectrum disorder (ASD) often experience heightened stress, anxiety, and social isolation, leading to a reduced quality of life when compared to the general population and caregivers of children with other chronic health conditions. Rural caregivers of children with ASD face additional challenges due to limited access to diagnostic and treatment services, which result in delayed ASD diagnoses and increased emergency department utilization. These families are at an elevated risk of adverse outcomes linked to both the challenges of rural living and the responsibilities of caring for a child with ASD. Therefore, it is imperative to identify scalable and accessible mental health resources that effectively alleviate the stress and anxiety experienced by these caregivers living in remote regions.
This study aims to bridge the research gap by offering an innovative mobile-app based mindfulness-training program designed to reduce stress and anxiety. In this interventional pilot study, participants in the trial will engage in a 30-day mindfulness program that they can complete over a maximum of 60 days. During this time, they will practice short daily mindfulness lessons and respond to a set of brief questions regarding their anxiety levels. The study will also collect data at baseline, midpoint, endpoint, and 1-year follow-up to assess adherence, satisfaction, and changes in stress and anxiety over time. Stakeholder involvement has been essential in shaping the study design, ensuring its relevance, and developing pathways for future studies.
The study targets rural caregivers of children with ASD living in Maine, aiming to include a total of 40 caregivers (20 cohabitating romantic couples). By integrating both parents into the intervention framework, this study seeks to harness their unique insights, enhance intervention participation, and provide a more comprehensive approach to addressing the complex mental health challenges in this population. This holistic approach, integrating the experiences and perspectives of both parents, strives to improve caregivers' well-being while also enhancing the care they provide for their children.
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
This study's planned enrollment of 40 is below the median of 49 across 813 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →MaineHealth is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All study participants will receive the app-based mindfulness intervention.
Behavioral: App-based Mindfulness Intervention
Participants in the trial will engage in a 30-day app-based mindfulness program called Unwinding Anxiety that they can complete over a maximum of 60 days. During this time, they will practice short daily mindfulness lessons and respond to a set of brief questions regarding their anxiety levels. Ultimately, we want to assess whether this intervention helps these caregivers feel less stressed and anxious.
stress
Parental Stress Scale (PSS). The PSS will be used to assess levels of stress experienced by caregivers with a child with autism as well as both positive and negative aspects of parenting. The PSS is a self-reported 18-item, 5-point Likert scale with responses ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The total possible score ranges from 18 to 90, after summing all items; with higher scores reflecting higher caregiver stress.
Time frame: admission, daily from study admission up to 60-days, completion of mindfulness training (anytime between days 30-60, this will vary by participant), 1-year follow-up
anxiety
Generalized Anxiety Disorder-7 Scale (GAD-7). The GAD-7 is a self-reported measure that consists of seven items measuring worry and anxiety. Each item is scored on a four-point Likert scale with responses ranging from 0 ("not at all") to 3 ("extremely"). The total possible scores range from 0 to 21, after summing all items; with higher scores reflecting greater anxiety severity.
Time frame: admission, daily from study admission up to 60-days, completion of mindfulness training (anytime between days 30-60, this will vary by participant), 1-year follow-up
intervention adherence
Adherence to the Unwinding Anxiety intervention will be measured by calculating the proportion of mindfulness training completed out of the 30 possible modules.
Time frame: daily from study admission up to 60-days
intervention satisfaction
Abbreviated Acceptability Rating Profile (AARP). The AARP will be used to assess satisfaction of the Unwinding Anxiety mobile application intervention. The AARP is a self-reported 8-item, 6-point Likert scale with responses ranging from 1("strongly agree") to 6 ("strongly agree"). The total possible scores range from 8 to 48, after summing all items; with higher scores reflecting higher intervention satisfaction.
Time frame: study midpoint (anytime between days 15-30, this will vary by participant) and completion of mindfulness training (anytime between days 30-60, this will vary by participant)
Plan to share: Yes — Our Individual Participant Data (IPD) sharing plan promotes responsible data sharing, prioritizing participant privacy and consent. It covers de-identified demographic, behavioral, and daily experience data from a 60-day mindfulness study. Data access requires formal agreements with qualified researchers, ensuring privacy and responsible usage. Collaboration and scientific contribution are encouraged, with data security measures including encryption and REDCap usage. The plan adheres to high ethical and privacy standards, striking a balance between research advancement and participant protection. It underscores our commitment to ethical data handling, fostering scientific progress while respecting participant privacy.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Immediately following publication. End date 3-5 years.
Access criteria: Access and Qualifications: Access to de-identified data will be granted exclusively to qualified researchers who enter into formal data sharing agreements. This approach serves to safeguard participant privacy and consent, limiting access to trusted individuals dedicated to responsible data utilization.
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Jun 2025, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is suspended, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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