Autism Spectrum DisorderNCT07501286
Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers
A study testing MINDful TIME and Mindfulness Mobile App in people with Autism Spectrum Disorder, run by Nicole Matthews, Ph.D. at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether a mindfulness-based intervention can reduce depression and anxiety in autistic adolescents. The main question this trial aims to answer is: Do adolescents who complete MINDful TIME show reductions in depression and anxiety compared to an active control group?… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- MINDful TIME and Mindfulness Mobile App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents must be ages 13 to 18 years
- Formal clinical or educational ASD diagnosis confirmed by the study team (i.e., review of formal diagnostic report from the diagnosing practitioner or Multidisciplinary Evaluation Team report (MET) shared with the research team by the family) )
- 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
Who cannot join
- 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 disability.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Southwest Autism Research & Resource Center
Phoenix, Arizona, 85006
Nicole Matthews, 480-582-9499, nmatthews@autismcenter.org
Nicole L Matthews, Ph.D.
About this study
The goal of this clinical trial is to learn whether a mindfulness-based intervention can reduce depression and anxiety in autistic adolescents. The main question this trial aims to answer is: Do adolescents who complete MINDful TIME show reductions in depression and anxiety compared to an active control group? Researchers will compare adolescents who complete MINDful TIME to adolescents who are instructed to use a mindfulness meditation mobile-app to see if changes in anxiety and depression differ between the two groups.
Participants will either:
Read more
- Attend weekly 90-minute MINDful TIME group meetings through Zoom with their parent or caregiver for a total of 8-weeks and use a mindfulness meditation app daily, or
- Use a mindfulness meditation app daily for 8-weeks
All participants will:
- Attend virtual intake, baseline, and follow-up visits to complete data collection
- Complete a weekly electronic meditation diary
- Conditions
- Autism Spectrum Disorder
- Being tested
- MINDful TIME, Mindfulness Mobile App
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDful TIMEBehavioural
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 Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for 5-20 minutes each day during and after the 8-week intervention.
Mindfulness Mobile AppBehavioural
Participants will receive access to the Happier app and brief instruction in Habit Formation strategies at the start of their intervention period. A trained member of the research team will provide participants instructions for anchoring their mindfulness meditation to a pre-existing habit (i.e., their morning bathroom routine). Like the treatment group, participants will be encouraged to meditate using the mobile app for 5-20 minutes each day during and after the 8-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| MINDful TIME Intervention | Experimental | Not described Receives: Behavioral: MINDful TIME |
| Mindfulness Mobile App | Active comparator | Not described Receives: Behavioral: Mindfulness Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Children's Depression Inventory (CDI) Scores
Parent-report measure of adolescent depressive symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of depression symptoms.
Measured: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores
Parent-report measure of adolescent anxiety symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of anxiety symptoms.
Measured: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores
Adolescent-report measure of mindfulness. Scores range from 0 to 40 with higher scores indicating higher levels of mindfulness.
Measured: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Secondary outcomes (6)
Mean Change from Baseline in Center for Epidemiological Studies Depression Scale (CESD-D)
Adolescent-report measure of depression. 20-item scale with scores ranging from 0 to 60. Higher scores indicate higher depression symptoms.
Measured: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores
Parent-report measure of adolescent executive function and self-regulation. Scores range from 30 to 90, with higher scores indicating higher levels of executive dysfunction.
Measured: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores
Parent self-report measure of mindfulness on observation, description, aware actions, non-judgmental inner experience, and non-reactivity. Factor scores range from 1 to 5, with higher scores indicating higher levels of mindfulness.
Measured: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores
Parent-report measure of the relationship of parenting stress to adolescent characteristics, parent characteristics, the quality of the adolescent-parent interactions, and stressful life circumstances. Percentile scores range from 0 to 99, with higher scores indicating higher levels of parenting stress.
Measured: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores
Adolescent-report measure of adolescent anxiety symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of anxiety symptoms.
Measured: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores
Parent self-report measure on current well-being. Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start24 Mar 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicole Matthews, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Southwest Autism Research & Resource Center, Arizona State University
- Responsible party
- Sponsor-investigator, Nicole Matthews, Ph.D., Southwest Autism Research & Resource Center
- Investigators
- Nicole Matthews, Ph.D., Principal investigator, Southwest Autism Research & Resource CenterBlair Braden, Ph.D., Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501286
- Sponsor's protocol ID
- 00023487
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers
- ClinicalTrials.gov ID
- NCT07501286
- Acronym / sponsor ID
- 00023487
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Nicole Matthews, Ph.D.University, hospital or other
- Collaborators
- Southwest Autism Research & Resource Center, Arizona State University
- Study start
- 24 Mar 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether a mindfulness-based intervention can reduce depression and anxiety in autistic adolescents. The main question this trial aims to answer is: Do adolescents who complete MINDful TIME show reductions in depression and anxiety compared to an active control group? Researchers will compare adolescents who complete MINDful TIME to adolescents who are instructed to use a mindfulness meditation mobile-app to see if changes in anxiety and depression differ between the two groups.
Participants will either:
- Attend weekly 90-minute MINDful TIME group meetings through Zoom with their parent or caregiver for a total of 8-weeks and use a mindfulness meditation app daily, or
- Use a mindfulness meditation app daily for 8-weeks
All participants will:
- Attend virtual intake, baseline, and follow-up visits to complete data collection
- Complete a weekly electronic meditation diary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINDful TIME Intervention | Experimental | Behavioral: MINDful TIME |
| Mindfulness Mobile App | Active comparator | Behavioral: Mindfulness Mobile App |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescents must be ages 13 to 18 years
- Formal clinical or educational ASD diagnosis confirmed by the study team (i.e., review of formal diagnostic report from the diagnosing practitioner or Multidisciplinary Evaluation Team report (MET) shared with the research team by the family) )
- 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
Key exclusion criteria (4 listed)
- 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 disability.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINDful TIMEThe 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 Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for 5-20 minutes each day during and after the 8-week intervention. | Behavioural | MINDful TIME Intervention |
| Mindfulness Mobile AppParticipants will receive access to the Happier app and brief instruction in Habit Formation strategies at the start of their intervention period. A trained member of the research team will provide participants instructions for anchoring their mindfulness meditation to a pre-existing habit (i.e., their morning bathroom routine). Like the treatment group, participants will be encouraged to meditate using the mobile app for 5-20 minutes each day during and after the 8-week intervention period. | Behavioural | Mindfulness Mobile App |
Primary outcome
Mean Change from Baseline in Children's Depression Inventory (CDI) Scores
Time frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Parent-report measure of adolescent depressive symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of depression symptoms.
Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores
Time frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Parent-report measure of adolescent anxiety symptoms. Scores range from 30 to 90 with higher scores indicating higher levels of anxiety symptoms.
Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores
Time frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Adolescent-report measure of mindfulness. Scores range from 0 to 40 with higher scores indicating higher levels of mindfulness.
6 secondary outcomes
Mean Change from Baseline in Center for Epidemiological Studies Depression Scale (CESD-D)
Time frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores
Time frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores
Time frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores
Time frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores
Time frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores
Time frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Matthews, Ph.D. principal investigator
Southwest Autism Research & Resource Center
Blair Braden, Ph.D. principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINDful TIME and Mindfulness Mobile App in people with Autism Spectrum Disorder, run by Nicole Matthews, Ph.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Melita ((480) 603-3285, omelita@autismcenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Children's Depression Inventory (CDI) Scores (time frame: Post-intervention (8 weeks); 2-month follow-up; 6-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.