Clinical trial NCT05685589: Mindfulness-Based Intervention for Teens With Autism Spectrum Disorder and Their Caregivers
Official title: Pilot Randomized Controlled Trial of a Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Southwest Autism Research & Resource Center
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: Blue Cross Blue Shield of Arizona Foundation for Community and Health Advancement
First posted: 2023-01-17
Enrollment: 42
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Change from Baseline in Children's Depression Inventory (CDI) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
measure: Mean Change from Baseline in Multidimensional Anxiety Scale for Children (MASC) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
measure: Mean Change from Baseline in Child and Adolescent Mindfulness Measure (CAMM) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
Secondary outcomes:
measure: Mean Change from Baseline in Beck Youth Inventories (BYI) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
measure: Mean Change from Baseline in World Health Organization-Five Wellbeing Index (WHO-5) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
measure: Mean Change from Baseline in Adaptive Behavior Assessment System (ABAS-3) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
measure: Mean Change from Baseline in Social Responsiveness Scale (SRS-2) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
measure: Mean Change from Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
measure: Mean Change from Baseline in Five Facets Mindfulness Questionnaire (FFMQ) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
measure: Mean Change from Baseline in Family Quality of Life Scale (FQOL) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
measure: Mean Change from Baseline in Stress Index for Parents of Adolescents (SIPA) Scores
timeFrame: Post-intervention (8 weeks); 2-month follow-up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Center
state: Arizona
Study officials:
affiliation: Arizona State University
name: Blair Braden, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Autism Research and Resource Center
name: Nicole Matthews, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: