Fit Families Program for Families of Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The purpose of the study is twofold. First, to identify the effect of a 12-week fundamental
      motor skills (FMS) (e.g., throwing, catching, running) intervention on the active
      participation in physical recreation activities as well as a variety of other factors (child
      behaviors, communication, and adaptive skills). Second, to identify patterns, benefits,
      constraints, and strategies to active participation in physical recreation activities among
      families of children with autism spectrum disorders (ASD) (pre-post) through in-person or via
      phone interviews with parents and children with ASD. Participants will be randomly assigned
      to one of three protocols: 1) Workshop group, 2) Home-based group, and 3) Wait-listed
      home-based group. Participants in all groups will receive an activity booklet (in the form of
      an App) and physical education-related activity items (e.g., ball, hoop).

      The investigators hypothesize that both the workshop and home-based groups will improve in
      all measures from pre to post compared to the wait-list control group. The investigators want
      to determine if the differences in the workshop and home-based groups differ significantly or
      are equitable in terms of gains in all areas.
    

Detailed description: 
      Participants will be randomly assigned to one of three groups (e.g., workshop, home-based, or
      control group) (pre-intervention)- [Parents and Children]. Group assignment will occur once
      pre-measurements/interviews data has been collected. Each family will be notified via email
      or phone which group they have been assigned (e.g., workshop, home-based, or control group)
      families within one week of the initial visit.

      * Note: Depending on the COVID situation and if necessary, some components of the program
      from in-person may be moved to virtual learning. Thus, instead of having three groups, there
      will be two groups. One online and a wait-listed control group. Parents will be notified
      about these changes verbally and/or via email.

      Parents and children assigned to the workshop group will be asked to participate in a 12 week
      FMS intervention (no more than three hours per session) and would be expected to engage in
      the physical activities provided (at least 3 hours per week). The homegroup would also be
      expected to engage in the physical activities provided (at least 3 hours per week). Instead
      of attending the in-person workshop, these participants will be able to attend the workshops
      remotely on zoom. A zoom link will be provided to the families the day before the workshop so
      they can join the event. The waitlist control group will continue the normal activities and
      would not be provided with physical activities or be expected to participate in any physical
      activities. Prior to the first workshop, parents in the home-based and the workshop group
      will be provided with the dates they should come to the Medical Science Building or Schools
      in the Madison School District (depending on availability) to collect the equipment and
      activity booklets (via the APP). Also, the investigators will indicate to parents in the
      workshop group that they will receive an email from the study team with additional
      information about the workshop and how to prepare for it. Parents in the wait-list control
      group will be notified of the tentative dates for the post and follow-up data collection, and
      a tentative time they will be able to benefit from the program (most likely fall 2021- spring
      2022).

      Participants in the workshop group will be offered four one-day workshops (3-hours each)
      covering topics of 1) Sensory Integration, 2) Communication, 3) Physical activity, and 4)
      Sports (during intervention)-[Parents and Children-Workshop Group]. These workshops will be
      offered in person. For the homegroup, these workshops will be offered online via Zoom. In
      addition to the workshops, this group and the home-based group will receive information
      (activity booklets via the Fit Families App) and physical education (physical
      activity)-related equipment. These activities are very similar to activities children will do
      during their physical education classes. Each face-to-face workshop is divided into two
      sessions. In the first session, parents attend a seminar and learn techniques and routines
      integrating the workshop topic into PA experiences that they will practice with their
      children in the second session. During the first session, children participate in physical
      activities led by trained staff, separate from their parents. After a mid-morning break, the
      parents and children are reunited and the parents practice the activities they learned with
      their children, under guided supervision and modeling from staff. This second session with
      support serves as a means of reinforcing recently presented skills and individualizing the
      instruction to the needs of each child and family.

      Families in this study (both groups) will be part of a private Facebook page in which they
      can ask questions or share information related to the program. In addition, study staff will
      be sharing teaching tips and answer questions families may have using the Facebook page.
      Making Facebook as an alternative and easy option for these families. WebEx or Zoom requires
      that users download an application into their computers or devices. The online portions of
      the program will be either pre-recorded or distributed live to each family (depending on
      conversations with Help Desk). Families will need to have access to internet services either
      through their phones or personal computers or devices. Note: To study team knowledge, these
      families have already access to the internet or mobile technology because, in order to
      participate in the study, they are required to complete an online application. The online
      session will not include the practice component in which parents practice the skills learned
      with their children. In turn, the investigators will ask families to share a video on the
      private Facebook page of them with their children practicing the skills. Parents will be
      given the option to send these videos privately to the study team or if they prefer, they can
      share their videos with the participants in the study (similar to what they will be doing in
      the face-to-face interactions). Each family will receive the equipment related to the
      workshop 2 days prior to the workshop. The study team will coordinate the pick-up time and
      location with each family. The duration of the online workshop is equivalent to face-to-face
      interactions (approximately 2 and a half hours). Breaks will be provided as requested by the
      participants.

      * Note: depending on the COVID pandemic and university regulations in terms of in-person
      contact, the study team may mail the equipment to the participant utilizing a local company
      (e.g., UPS, etc).

      Participants in the home-based group will not participate in the four half-day workshops
      (face to face), but they will receive the same information remotely (workshop content) and
      will have access to the activity booklets (via the App) and physical activity equipment as
      the workshop group (during intervention)-[Parents and Children-Home Group]. These two groups
      (workshop group and home-based group) will be part of two separate closed Facebook page in
      which only participants enrolled in the page will have access to the content. The purpose of
      this Facebook page is to have a place in which parents can share information or ask questions
      to other parents about the physical activities and the physical education-related equipment
      they will receive. The study team will have access to the Facebook page to monitor the page
      and provide feedback when needed.

      Participants in the workshop and home-based group will be contacted by members of the
      research team on a weekly basis (during the length of the program) by phone or via email
      (depending on parental preferences) to follow up on the progress of each family and to
      clarify questions they may have regarding the information provided. In addition, participants
      in both intervention groups will receive weekly motivational text messages encouraging them
      to continue practicing the activities.

      Note: The study team will be taking photographs and videos of participants (parents and
      children) during the workshops at the Medical Science Building or Schools in the Madison
      School District (depending on availability) and/or during data collection. The photos and the
      videos will be used for educational purposes.

      The third group (wait-list home-based group) will serve as the control group (during
      intervention)-[Parents and Children-Control Group]. This group will be instructed to continue
      their typical routines and activities for the duration of the intervention. They will be
      asked to attend the pre and post-test, as well as a follow-up three weeks after the
      completion of the 12-week period. Immediately following the follow-up test, participants in
      the wait-list home-based group will be offered the home-based program (e.g., receiving the
      same intervention protocol and materials (physical education equipment and lesson
      plans/workbook) following all procedures as described for that group previously.

      The initial cohort of this study was registered to NCT04612647.
    

Intervention name(s): 12-week FMS Intervention; Physical Activities & Activity Booklets (via FitFamilies app)
Intervention type(s): Other; Behavioral
Intervention description(s): 4 sessions, no more than 3 hours per session covering 1) Sensory Integration, 2) Communication, 3) Physical activity, and 4) and Sports (during intervention); expected to engage in physical activity at least 3 hours per week, parent workshops provide them with resources to engage in Physical activity
Other intervention name(s): Parent workshops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other