Clinical trial NCT06577623: In-Person Mindfulness-based Intervention for Adolescents with Autism Spectrum Disorder and Their Caregivers
Official title: In-Person Mindfulness-based Intervention for Adolescents with Autism Spectrum Disorder and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Lead sponsor: Southwest Autism Research & Resource Center
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2024-08-29
Enrollment: 28
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label feasibility and acceptability trial.
Primary purpose: TREATMENT

Brief 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.

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.

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 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

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 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 Stress Index for Parents of Adolescents (SIPA) 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
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Center
state: Arizona
Study officials:
affiliation: Southwest Autism Research & Resource Center
name: Nicole Matthews, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: