Mindfulness-Based Intervention for Teens With Autism Spectrum Disorder and Their Caregivers

Autism Spectrum Disorder Clinical Trial

Official title:

Pilot Randomized Controlled Trial of a Telehealth Mindfulness-based Intervention for Adolescents With Autism Spectrum Disorder and Their Caregivers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05685589
• Other study ID #: 00016672
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Southwest Autism Research & Resource Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• MINDful TIME
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.

Locations

Country	Name	City	State
United States	Southwest Autism Research and Resource Center	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Southwest Autism Research & Resource Center	Arizona State University, Blue Cross Blue Shield of Arizona Foundation for Community and Health Advancement

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post-intervention (8 weeks); 2-month follow-up
Primary	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.	Post-intervention (8 weeks); 2-month follow-up
Primary	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.	Post-intervention (8 weeks); 2-month follow-up
Secondary	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.	Post-intervention (8 weeks); 2-month follow-up
Secondary	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.	Post-intervention (8 weeks); 2-month follow-up
Secondary	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.	Post-intervention (8 weeks); 2-month follow-up
Secondary	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.	Post-intervention (8 weeks); 2-month follow-up
Secondary	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.	Post-intervention (8 weeks); 2-month follow-up
Secondary	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.	Post-intervention (8 weeks); 2-month follow-up
Secondary	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.	Post-intervention (8 weeks); 2-month follow-up
Secondary	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.	Post-intervention (8 weeks); 2-month follow-up