Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Autism
  • Autism Spectrum Disorder
  • Stress
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Feasibility studyMasking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

This study is designed to: Conduct 3 focus groups with caregivers of autistic children to understand specific stressors that they experience; Gather baseline data including blood samples (for immune system markers; collected only from the parents of children with autism) and surveys of health and we...

This study is designed to: Conduct 3 focus groups with caregivers of autistic children to understand specific stressors that they experience; Gather baseline data including blood samples (for immune system markers; collected only from the parents of children with autism) and surveys of health and well-being; Administer an individualized wellness program by using motivational interviews (MI) to individually tailor the program for each participant, train participants to use an app designed to support the adoption of lifestyle changes; Coach participants over the 4-6 months of their program; and Assess the usability of the app and the impact of the wellness program on caregiver's health and well-being. First, to facilitate the tailoring of the program, the investigator will consult with a subsample of participants about the user-friendliness of the app, observe the participant navigating the app, and ask them about unique or specific stressors that they experience (Focus group). Based on feedback received from the session, the app will be revised and the coach training will be adapted in response to the grandparent caregivers' life stressors. Participants will be invited to the University of Wisconsin-Madison campus (for parents of children with autism) or to the Rainbow Project (for grandparent sample) where they will: complete baseline surveys of physical and mental health, mindfulness, stress, and wellbeing (Center for Epidemiology Depression Scale -Revised; Five Facet Mindfulness Questionnaire; Perceived Stress Scale; Psychological Well-being Scale; Rand Short Form-36), get introduced to the study procedures and research team (Principal Investigator, Researcher, and MI-trained Masters-level occupational therapy and counseling graduate students); and participate in focus groups to introduce the 5Minutes4Myself program, offer data on current lifestyles, and receive training (for grandparents) on how to use the app (For parents of children with autism only) receive a blood test for serum cytokines. A phlebotomist will be on-hand for blood draws. Parking will be provided to participants for events hosted on campus (focus group and post-intervention assessments). Parking is available at Rainbow Project for grandparents. Participants will be assigned coaches. They will work together in an initial lifestyle coaching session and continue meeting monthly for 4-6 months. To assess the fidelity of the coaching sessions, motivation interviewing sessions (initial and monthly) will be audio-- or video--taped to assess fidelity via the Motivational Interviewing Treatment Integrity tool (MITI). Participants will be asked to complete an assessment of their satisfaction with the coaching. Data will be archived for the ongoing project. The coaches will use Motivational Interviewing strategies to identify barriers to implementing the mindfulness program, foster commitment talk, and elicit the participant's strategy for implementing the mindfulness program in their daily life. Participants may request additional consultation through the weekly app goal check-in or via email. The app will host all baseline surveys allowing them to be completed electronically. The baseline surveys will be completed prior to the first coaching session. The app will also be used as a "habit builder" providing personalized notifications as to when a goal activity will be created, will have three option goal check ins for each goal (doing great, making progress, don't ask), and will collect usage data for audio mindfulness podcasts that are part of the program. Usage data will show how often and for how long participants listened to a podcast during the intervention. After completing the 4-6 month intervention, participants will return for another workshop that will include: Completion of Focus Group session 3; Re-administration of 'baseline' surveys (now considered 'post-intervention'); Assessing the usability of the app via the MSUS; and Final blood draw for only the parents of children with autism.

Tracking Information

NCT #
NCT03771001
Collaborators
Not Provided
Investigators
Principal Investigator: Elizabeth Larson, PhD University of Wisconsin, Madison