University of Wisconsin- Madison
Madison, Wisconsin, 53706, United States
NCT Number: NCT05451459
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.
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Notify Me4 year–11 year
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53706, United States
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):
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Note: While the children will be benefiting from this program, participants in this study will be the parents
Exclusion criteria
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
Time frame: Baseline, 3 week post intervention (15 weeks)
The Parenting Stress Index (PSI)- short form is used to measure the relative stress in the parent-child relationship. Parents complete the PSI Short Form test sheet including basic demographic information on the top of the questionnaire first. For most items, parents should respond by circling SA (strongly agree), A (agree), NS (not sure), D (disagree), SD (strongly disagree). Higher raw scores indicate higher levels of stress. Percentile scores that fall between 15 and 80 are considered typical.
Time frame: Baseline, 3 week post intervention (15 weeks)
To evaluate adaptive behavior skills of the child. The ABAS-3 covers three broad adaptive domains: Conceptual, Social, and Practical. Within these domains, it assesses 11 adaptive skill areas (each form assesses 9 or 10 skill areas based on age range). Items focus on practical, everyday activities required to function, meet environmental demands, care for oneself, and interact with others effectively and independently. On a four-point response scale, raters indicate whether the individual can perform each activity, and if so, how frequently they perform it when needed. The ratings for each skill are converted into a score from 1 to 19 with a higher score indicative of higher adaptive behavior skills.
Time frame: Baseline, 3 week post intervention (15 weeks)
The Developmental Coordination Questionnaire (DCDQ) is a parent report measure developed to assist in the identification of Developmental Coordination Disorder (DCD) in children. Parents are asked to compare their child's motor performance to that of his/her peers using a 5 point Likert scale. Most of the motor skills that this questionnaire asks about are things that a child does with his or her hands, or while moving. The scale ranges from 1 (not at all like your child) to 5 (extremely like your child).
Time frame: Baseline, 3 week post intervention (15 weeks)
TOPSE: Tool to measure Parenting Self-Efficacy is used to measure play and enjoyment. The scale ranges from 0 (completely disagree) to 10 (completely agree). On a ten-point response scale, raters indicate how much they agree with each statement
University of Wisconsin, Madison
Other
Fit Families Program: A Multisite Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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