Autism Spectrum DisorderNCT06577623
In-Person Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers
A study testing MINDful TIME in people with Autism Spectrum Disorder and Autism, run by Southwest Autism Research & Resource Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- MINDful TIME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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
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 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Autism Research and Resource Center
Phoenix, Arizona, 85006
About this study
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.
Read the detailed description
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
- Autism Spectrum Disorder, Autism
- Being tested
- MINDful TIME
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDful TIMEBehavioural
Group-based psychoeducational mindfulness-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| MINDful TIME group | Experimental | 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 Receives: Behavioral: MINDful TIME |
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
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
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
Secondary outcomes (7)
Mean Change from Baseline in Beck Youth Inventories (BYI) Scores
Adolescent-report measure of depression. Scores range from 0 to 90, with higher scores indicating higher levels of depression.
Measured: Post-intervention (8 weeks); 2-month follow-up
Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores
Adolescent-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
Mean Change from Baseline in Adaptive Behavior Assessment System (ABAS-3) Scores
Parent-report measure of adolescent adaptive skills across the lifespan. Scores range from 40 to 120, with higher scores indicating better adaptive skills.
Measured: Post-intervention (8 weeks); 2-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
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores
Adolescent-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
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
Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores
Parent-report measure of adolescent presence and severity of social impairment within autism spectrum. T-scores range from 30 to \> 90 with higher scores indicating greater social impairment.
Measured: Post-intervention (8 weeks); 2-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 posted29 Aug 2024
- Study start14 Aug 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label feasibility and acceptability trial.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Autism Research & Resource Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Sponsor
- Investigators
- Nicole Matthews, Ph.D., Principal investigator, Southwest Autism Research & Resource Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577623
- Sponsor's protocol ID
- 00016672b
- Status last verified
- Mar 2026
- First submitted
- 27 Aug 2024
- 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
- In-Person Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers
- ClinicalTrials.gov ID
- NCT06577623
- Acronym / sponsor ID
- 00016672b
- Conditions
- Autism Spectrum Disorder, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Southwest Autism Research & Resource CenterUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 29 Aug 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label feasibility and acceptability trial.
| Arm | Type | Receives |
|---|---|---|
| MINDful TIME group | Experimental | Behavioral: MINDful TIME8-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 may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
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 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
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 TIMEGroup-based psychoeducational mindfulness-based intervention. | Behavioural | MINDful TIME group |
Primary outcome
Mean Change from Baseline in Children's Depression Inventory (CDI) Scores
Time frame: Post-intervention (8 weeks); 2-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
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
Adolescent-report measure of mindfulness. Scores range from 0 to 40 with higher scores indicating higher levels of mindfulness.
7 secondary outcomes
Mean Change from Baseline in Beck Youth Inventories (BYI) Scores
Time frame: Post-intervention (8 weeks); 2-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
Mean Change from Baseline in Adaptive Behavior Assessment System (ABAS-3) Scores
Time frame: Post-intervention (8 weeks); 2-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
Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores
Time frame: Post-intervention (8 weeks); 2-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
Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores
Time frame: Post-intervention (8 weeks); 2-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
Nicole Matthews, Ph.D. principal investigator
Southwest Autism Research & Resource Center
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 in people with Autism Spectrum Disorder and Autism, run by Southwest Autism Research & Resource Center 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 4 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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). 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.