Fit Families Multisite
Condition: Developmental Disability; Intellectual Disability
MeSH terms: Intellectual Disability; Developmental Disabilities
Study type: Interventional

Summary: 
      The purpose of the study is twofold. First, the investigator wants to identify the effect of
      a 12-week online fundamental motor skills (FMS) (e.g., throwing, catching, running)
      intervention on active participation in physical recreation activities as well as a variety
      of other factors(parental stress, parental self-efficacy, and children's adaptive skills).
      Second, the investigator also wants to identify patterns, benefits, constraints, and
      strategies to active participation in physical recreation activities among families of
      children with developmental disabilities such as autism, down syndrome, etc (post-program)
      via focus groups interviews (via zoom) with parents. Participants will be randomly assigned
      to one of two protocols: 1) Intervention group and 2) wait-listed home-based group.
      Participants in both groups will receive an activity booklet (in the form of an App) and
      physical education-related activity items (e.g., ball, hoop). The investigator hypothesizes
      that both the intervention group will improve in all measures from pre to post compared to
      the wait-list control group. The study team wants to determine if the differences in the
      intervention group differ significantly or are equitable in terms of gains in all areas.
    

Detailed description: 
      Prior to participating in the program, interested families will complete an electronic
      screening questionnaire via Qualtrics (Initial Screening Evaluation) to identify if their
      family are eligible to participate in this study. On the Initial Screening Evaluation,
      parents will be asked to report on their children's previous diagnoses, ambulatory ability,
      significant behavior needs, ability to follow directions, and independent or assisted
      communication. Parents will need to confirm that their children are ambulatory and are
      diagnosed with a developmental disability. Children with significant communication needs will
      still be considered for the study. No new disability diagnostic assessment will be conducted.
      Diagnostic severity of disability will not be a factor in recruitment. The information
      provided will not be used as part of the data collection process. If participants are not
      eligible to participate, this information will be deleted (see Initial Screening Evaluation).

      Once the initial Screening Evaluation has been received, the Principal Investigator (PI), Dr.
      Luis Columna, or his graduate and/or undergraduate students will contact participants to
      confirm that they have received the application. During this phone call, the study team will
      explain in more detail the purpose of the program, time commitment, potential risk, benefits,
      and answer any questions about the study.

      The following steps describe the structure of the intervention (activities):

        1. Parents in both groups will be asked to complete a Qualtrics survey (includes questions
           from Parenting Stress Index, TOPSE, DCDQ, and ABAS-3) inquiring about demographic
           information and or child's disability. This qualtrics survey will be embedded in the Fit
           Families App. *Note: The Fit Families app, which was developed by the study team using
           the Glide app. In this app, parents will receive a secured qualtrics link that will
           allow them to complete the surveys. The Fit Families App will not collect the data.
           However, it will be the mechanism to distribute the qualtrics surveys to the
           participants.

        2. After the completion of the questionnaires, participants will be randomly assigned to
           one of two groups (e.g., intervention group or Wait-list control group). Group
           assignment will occur once pre-survey data has been collected. Each family will be
           notified via email or phone which group they have been assigned (e.g., Intervention or
           control group) within one week of the initial survey. The intervention group will be
           provided with the dates of the intervention workshop and mailed a set of physical
           activity equipment to use for practicing the skills outlined in the workshop. Similar
           approaches have been used in previous Fit Families program.

             -  Participants in the intervention group will be offered four one-day group workshops
                (2-3 hours each) covering topics of 1) Sensory Integration, 2) Communication, 3)
                Physical activity, and 4) Sports. These workshops will be offered online via Zoom
                and will be video recorded. In addition to the workshops, the intervention group
                will receive information (activity booklets via the Fit Families App) and physical
                education (physical activity)-related equipment, which will be mailed to them. The
                activities discussed in the workshops are very similar to activities children will
                do during their physical education classes. During each workshop, parents will
                attend an online seminar and learn techniques and routines integrating the workshop
                topic into experiences. While attending the workshops, parents can ask questions
                using the chat feature of zoom or provided the opportunity to unmute themselves and
                ask questions to the speakers. The parents will also be able to show or send the
                study team videos/photos of them doing the activities with their child (which the
                research team will keep for research purposes if participant consents) so they can
                obtain feedback on their practice. The study team will provide a break in between
                for the participants. At the end of the workshop parents will be instructed to
                practice the skills they learned with their child for the next 3 weeks (for at
                least 3 hrs per week)

      Zoom requires that users download an application to their computer or devices. The online
      portions of the workshop program will be either pre-recorded or distributed live to each
      family (depending on conversations with the Help Desk). Families will need to have access to
      internet services either through their phones or personal computers or devices. Note: To the
      investigator's 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 study team will ask
      families to share a video via box of them with their children practicing the skills. Each
      family will receive the equipment related to the workshop 2 days prior to the workshop. Staff
      from the Department of Kinesiology, in coordination with Dr. Columna or his graduate and
      undergraduate students, will mail the equipment to each family to the families in Wisconsin.
      The equipment to the families in Upstate New York, will be mailed by staff personnel from
      Syracuse University. The personnel at Syracuse will not have access to the identifiable data
      collected on participants. The duration of the online workshop will be approximately 2 and a
      half hours). Breaks will be provided as requested by the participants.

      Participants in the intervention group will then be contacted by members of the research team
      on a weekly basis (during the length of the program) by text, or via email (depending on
      parental preferences) to encourage participation and usage of the games and activities
      provided.

      At the culmination of the program, participants in the intervention group will be invited to
      participate in a focus group (via zoom) with members of the research team to explore their
      perception regarding communication strategies, patterns of physical recreation, perceived
      benefits, and constraints (see attached interview questions) and the duration of the focus
      group will be between 45 to 90 minutes. Breaks will be provided if necessary or if requested.
      The focus groups will also be video recorded.

      • The wait-list home-based group will serve as the control group (during intervention). This
      group will be instructed to continue their typical routines and activities for the duration
      of the 12-week intervention. At the end of the 12 weeks, they will be asked to complete the
      post-test surveys (same as questionnaires completed prior to randomization). Their
      participation in the research will be complete at this time. However, because the
      intervention has been shown to potentially benefit families, immediately following the
      post-test, participants in the wait-list home-based group will be offered the chance to
      complete the home-based intervention program (e.g., receiving the same intervention protocol
      and materials (physical education equipment and lesson plans/workbook) as described for the
      intervention group). No data will be collected for research from them during this time
    

Intervention name(s): 12-week FMS Intervention; Physical Activities & Activity Booklets (via FitFamilies app)
Intervention type(s): Other; Behavioral
Intervention description(s): 4 virtual workshops (2-3 hours each) covering topics of 1) Sensory Integration, 2) Communication, 3) Physical activity, and 4) Sports (during intervention); expected to engage in physical activity at least 3 hours per week, virtual workshops provide them with resources to engage in Physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other