Fit Families Program: A Multisite Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in Parenting Stress Index (PSI)- Short form
研究概览
简要总结
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.
详细描述
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):
- 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.
- 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents (one per family) of children with developmental and intellectual disabilities ages 4 to 11 will be included. Because this study is focused on families (parents) of children with developmental and intellectual disabilities, in order to participate, developmental and intellectual disabilities must be the primary disability. Children could have other disabilities besides developmental and intellectual disabilities, but developmental and intellectual disabilities must be their primary disability. Diagnostic severity of developmental and intellectual disabilities will not be a factor in recruitment. Recruitment will be based on diagnosis and the ability to participate in the program activities. Children must be ambulatory and able to follow verbal or picture directions with support. Children with significant communication needs will still be considered for the study. For adults (parents of children with developmental and intellectual disabilities) there will not be an age restriction. In addition, parents should be ambulatory and not have any restrictions to do physical activity. Lastly, because this study is focused on the States of Wisconsin and New York, participants need to reside either in the State of Wisconsin or in the State of New York, particularly upstate New York.
- •Note: While the children will be benefiting from this program, participants in this study will be the parents
排除标准
- •Children with developmental and intellectual disabilities younger than 4 years old and older than 11 years old will be excluded from this research study. Because this study is focused on families (parents) of children with developmental and intellectual disabilities, parents of children with other primary disabilities, or parents who do not have children with developmental and intellectual disabilities will be excluded. Participants cannot exhibit aggressive behavior. Children who are non-ambulatory or participants (children) with significant behavioral or sensory impairments will also be excluded based on application information, including existing behavior intervention plans and existing school information. Participants who are not residents of the States of New York or Wisconsin will not be able to participate in this study.
结局指标
主要结局
Change in Parenting Stress Index (PSI)- Short form
时间窗: 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.
DCDQ: Developmental Coordination Disorder Questionnaire
时间窗: 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).
TOPSE: Tool to measure Parenting Self-Efficacy
时间窗: 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
Change in Adaptive Behavior Assessment System (ABAS-3)
时间窗: 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.
次要结局
未报告次要终点