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In-Person Mindfulness-based Intervention for Adolescents with Autism Spectrum Disorder and Their Caregivers

S

Southwest Autism Research & Resource Center

Status

Enrolling

Conditions

Autism Spectrum Disorder
Autism

Treatments

Behavioral: MINDful TIME

Study type

Interventional

Funder types

Other

Identifiers

NCT06577623
00016672b

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

MINDful TIME group
Experimental group
Description:
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
Treatment:
Behavioral: MINDful TIME

Trial contacts and locations

1

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Central trial contact

Nicole Matthews, Ph.D.

Data sourced from clinicaltrials.gov

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