Autism Spectrum DisorderNCT05685589
Mindfulness-Based Intervention for Teens With Autism Spectrum Disorder and Their Caregivers
A study testing MINDful TIME in people with Autism Spectrum Disorder, run by Southwest Autism Research & Resource Center at 1 site in United States.
Trial summary
This project will evaluate the effectiveness of MINDful TIME, an 8-week mindfulness-based program designed to improve mental health in adolescents with autism spectrum disorder and their caregivers. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2023to 8 Apr 2024
- 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 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
- Participants must live in the state of Arizona, USA
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
Official title: Pilot Randomized Controlled Trial of a Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers
This project will evaluate the effectiveness of MINDful TIME, an 8-week mindfulness-based program designed to improve mental health in adolescents with autism spectrum disorder and their caregivers. MINDful TIME includes weekly psychoeducational group meetings conducted through videoconferencing and use of a commercially available mindfulness meditation app. The investigators predict that adolescents in the mindfulness intervention group will demonstrate increases in self-reported mindfulness and reductions in self- and parent-reported anxiety and depression relative to a delayed treatment control group. The investigators will also explore whether caregivers in the treatment group demonstrate improvements in quality of life.
Read the detailed description
Interested individuals and their parent/caregiver who meet preliminary eligibility criteria during the phone screen will be scheduled for a 1-2 hour virtual study visit to complete an intake interview for study and a brief IQ test. If individuals have completed this assessment at SARRC within the last five years, they will not be re-assessed; however, they will complete a 30-minute virtual intake visit to complete the intake interview, learn about the intervention and determine if they would like to participate.
Participants in the treatment group will complete three virtual study visits (Baseline, intervention exit, 2-month follow-up), whereas participants in the delayed treatment control group will complete four virtual study visits (Baseline, wait for the period exit, intervention exit, 2 month-follow-up). After completing their second-time point (i.e., wait period exit) participants in the delayed treatment control group will be enrolled in the 8-week intervention.
The investigators anticipate that the duration of an individual participant's participation in the study from baseline data collection to study completion will be approximately 6 months. Participants may be enrolled up to 8 months prior to their baseline data collection depending on when they are recruited into the study and whether they participate in cohort 1 or cohort 2.
- Conditions
- Autism Spectrum Disorder
- Being tested
- MINDful TIME
- 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 Ten Percent Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for at least 10 minutes each day during and after the 8-week intervention.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Intervention | Experimental | 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 Ten Percent Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for at least 10 minutes each day during and after the 8-week intervention. Receives: Behavioral: MINDful TIME |
| Delayed Treatment Control | No intervention | Participants will be instructed to engage in treatment as usual during their 8-week wait period. After their wait period, participants will be enrolled in the mindfulness-based intervention. |
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 (8)
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 Social Responsiveness Scale (SRS-2) Scores
Parent-report measure of adolescent presence and severity of social impairment within autism spectrum.
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 Family Quality of Life Scale (FQOL) Scores
Parent-report measure of family quality of life in family interaction, parenting, emotional well-being, physical/material well-being, and disability-related support. Scores range from 1 to 5, with higher scores indicating higher satisfaction with family quality of life.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start4 Jan 2023
- Primary completion30 Jan 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Autism Research & Resource Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, Blue Cross Blue Shield
- Responsible party
- Principal investigator, Nicole Matthews, Ph.D., Southwest Autism Research & Resource Center
- Investigators
- Blair Braden, Ph.D, Principal investigator, Arizona State UniversityNicole Matthews, Ph.D, Principal investigator, Southwest Autism Research and Resource Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685589
- Sponsor's protocol ID
- 00016672
- Status last verified
- Jul 2024
- First submitted
- 5 Jan 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.
Publications
Matthews NL, Mitchell MM, Honda H, Malligo A, Boyd S, Pagni BA, Blair Braden B. Pilot randomized controlled trial of MINDful TIME, a novel telehealth mindfulness-based intervention for autistic adolescents and their caregivers. Autism. 2025 Jul;29(7):1864-1882. doi: 10.1177/13623613251328484. Epub 2025 Mar 31.
PubMed 40160168
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of a Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers
- ClinicalTrials.gov ID
- NCT05685589
- Acronym / sponsor ID
- 00016672
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Southwest Autism Research & Resource CenterUniversity, hospital or other
- Collaborators
- Arizona State University, Blue Cross Blue Shield
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 17 Jan 2023 (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.
This project will evaluate the effectiveness of MINDful TIME, an 8-week mindfulness-based program designed to improve mental health in adolescents with autism spectrum disorder and their caregivers. MINDful TIME includes weekly psychoeducational group meetings conducted through videoconferencing and use of a commercially available mindfulness meditation app. The investigators predict that adolescents in the mindfulness intervention group will demonstrate increases in self-reported mindfulness and reductions in self- and parent-reported anxiety and depression relative to a delayed treatment control group. The investigators will also explore whether caregivers in the treatment group demonstrate improvements in quality of life.
Detailed description
Interested individuals and their parent/caregiver who meet preliminary eligibility criteria during the phone screen will be scheduled for a 1-2 hour virtual study visit to complete an intake interview for study and a brief IQ test. If individuals have completed this assessment at SARRC within the last five years, they will not be re-assessed; however, they will complete a 30-minute virtual intake visit to complete the intake interview, learn about the intervention and determine if they would like to participate.
Participants in the treatment group will complete three virtual study visits (Baseline, intervention exit, 2-month follow-up), whereas participants in the delayed treatment control group will complete four virtual study visits (Baseline, wait for the period exit, intervention exit, 2 month-follow-up). After completing their second-time point (i.e., wait period exit) participants in the delayed treatment control group will be enrolled in the 8-week intervention.
The investigators anticipate that the duration of an individual participant's participation in the study from baseline data collection to study completion will be approximately 6 months. Participants may be enrolled up to 8 months prior to their baseline data collection depending on when they are recruited into the study and whether they participate in cohort 1 or cohort 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Intervention | Experimental | Behavioral: 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 Ten Percent Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for at least 10 minutes each day during and after the 8-week intervention. |
| Delayed Treatment Control | No intervention | –Participants will be instructed to engage in treatment as usual during their 8-week wait period. After their wait period, participants will be enrolled in the mindfulness-based intervention. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 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 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 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 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 Ten Percent Happier, a commercially-available mobile app. Participants will be encouraged to meditate using the mobile app for at least 10 minutes each day during and after the 8-week intervention. | Behavioural | Mindfulness-based Intervention |
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.
8 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 Social Responsiveness Scale (SRS-2) 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 Family Quality of Life Scale (FQOL) 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
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 17 Jul 2024.
- Derived from this study: PubMed 40160168Matthews NL, Mitchell MM, Honda H, Malligo A, Boyd S, Pagni BA, Blair Braden B. Pilot randomized controlled trial of MINDful TIME, a novel telehealth mindfulness-based intervention for autistic adolescents and their caregivers. Autism. 2025 Jul;29(7):1864-1882. doi: 10.1177/13623613251328484. Epub 2025 Mar 31.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in a publication will be available upon request to approved researchers.
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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.
Blair Braden, Ph.D principal investigator
Arizona State University
Nicole Matthews, Ph.D principal investigator
Southwest Autism Research and 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, 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 6 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 17 Jul 2024. 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?
On the ClinicalTrials.gov record for NCT05685589, which also lists 1 linked publication.
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 17 Jul 2024.