Autism Spectrum DisorderNCT05159102
Fit Families Program for Families of Children With Autism Spectrum Disorder
A study testing 12-week FMS Intervention and Physical Activities & Activity Booklets (via FitFamilies app) in people with Autism Spectrum Disorder, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- 12-week FMS Intervention and Physical Activities & Activity Booklets (via FitFamilies app)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2021to 8 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASD must be the primary disability of the child
- Children will be considered to have ASD if they score above the clinical cutoff or 15 on both the lifetime and current versions of the SCQ. Diagnostic severity of ASD will not be a factor in recruitment.
- Children must be able 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
- No age restriction for adults (parents of children with ASD)
- Parents should be ambulatory and not have any restriction to do physical activity
Who cannot join
- Parents of children with other primary disabilities, or parents who do not have children with ASD 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fit Families Program: Fundamental Motor Skill Intervention in Children With Autism Spectrum Disorders and Their Parents
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- 12-week FMS Intervention, Physical Activities & Activity Booklets (via FitFamilies app)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week FMS InterventionOther
4 sessions, no more than 3 hours per session covering 1) Sensory Integration, 2) Communication, 3) Physical activity, and 4) and Sports (during intervention)
Physical Activities & Activity Booklets (via FitFamilies app)Behavioural
Also called Parent workshops
expected to engage in physical activity at least 3 hours per week, parent workshops provide them with resources to engage in Physical activity
| Study group | Role | What they receive |
|---|---|---|
| Workshop group | Experimental | 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. 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. Receives: Other: 12-week FMS Intervention; Behavioral: Physical Activities & Activity Booklets (via FitFamilies app) |
| Home-based group | Experimental | 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]. Receives: Other: 12-week FMS Intervention; Behavioral: Physical Activities & Activity Booklets (via FitFamilies app) |
| wait-listed home-based group | Other | 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 posttest, 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. Receives: Behavioral: Physical Activities & Activity Booklets (via FitFamilies app) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Development as Measured by TGMD-3
The Test of Gross Motor Development - second edition (TGMD-3) is a measure of fundamental motor skills. The total possible range of scores is 47-158, where higher scores are indicative of improved gross motor development.
Measured: Baseline, 3 week post intervention (15 weeks)
Change in qualitative perceptions of the participants as measured via semi-structured interview.
Children will participate in one-on-one semi-structured interviews with the research team to explore their perception regarding communication strategies (between parent and child), patterns of physical recreation, perceived benefits, and constraints.
Measured: baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks), follow up (24 weeks)
Change in Social Communication Questionnaire (SCQ)
The SCQ is a 40-item survey where each question is a 'yes' or 'no' answer. The total possible range of scores is 0-39 (verbal children) or 0-33 (non-verbal children) with higher scores indicative of greater frequency of symptoms.
Measured: baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks)
Change in Parenting Stress Index (PSI)- Short form
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.
Measured: Baseline, 3 week post intervention (15 weeks)
Change in Sensory Profile (Dunn 1999)
The Sensory Profile (Dunn, 1999) is designed to function as a part of a broader assessment of a child's functioning, which may include other observations, history, and diagnostic tests. The parent/caregiver reports the frequency of the behaviors in question, utilizing a Likert scale of always, frequently, occasionally, sometimes, and never. The Sensory Profile consists of 125 items grouped into three main sections: sensory processing, modulation, and behavioral and emotional responses.
Measured: Baseline, 3 weeks post intervention (15 weeks)
Change in the Behavioral Assessment System for Children (BASC-III) (Reynolds & Kamphaus, 2015)
To evaluate social behavior, problem behavior, and emotionality of the child. The narrative and scale classifications in this report are based on T scores obtained using norms. Scale scores in the Clinically Significant range suggest a high level of maladjustment. Scores in the At-Risk range may identify a significant problem that may not be severe enough to require formal treatment or may identify the potential of developing a problem that needs careful monitoring.
Measured: Baseline, 3 week post intervention (15 weeks)
Change in Adaptive Behavior Assessment System (ABAS-3)
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.
Measured: Baseline, 3 week post intervention (15 weeks)
Change in Physical Activity Questionnaire
Parents will be asked to complete a weekly Qualtrics survey inquiring about the type of activities and time they spend participating in those activities. In this survey, parents will comment on the FMS strategies they used or did not use during the week(s).
Measured: Baseline, weekly throughout the 12 weeks, post intervention (15 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start6 Aug 2021
- Primary completion8 Jan 2022
- Study completion8 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis A Columna, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159102
- Sponsor's protocol ID
- 2019-1256 New Cohort
- Other IDs
- A176000, EDUC/KINESIOLOGY/KINESIO
- Status last verified
- Jan 2022
- First submitted
- 11 Oct 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prieto LA, Meera B, Barry A, Swarup G, Asmus J, Ku B, Roth K, Foley JT, Columna L. A randomized parent-mediated physical activity intervention for autistic children. Autism Res. 2023 Jul;16(7):1450-1461. doi: 10.1002/aur.2969. Epub 2023 Jun 26.
PubMed 37357811
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit Families Program: Fundamental Motor Skill Intervention in Children With Autism Spectrum Disorders and Their Parents
- ClinicalTrials.gov ID
- NCT05159102
- Acronym / sponsor ID
- 2019-1256 New Cohort
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 8 Jan 2022 (actual)
- Study completion
- 8 Jan 2022 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Workshop group | Experimental | Other: 12-week FMS Intervention, Behavioral: Physical Activities & Activity Booklets (via FitFamilies app)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. 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. |
| Home-based group | Experimental | Other: 12-week FMS Intervention, Behavioral: Physical Activities & Activity Booklets (via FitFamilies app)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]. |
| wait-listed home-based group | Other | Behavioral: Physical Activities & Activity Booklets (via FitFamilies app)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 posttest, 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. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- ASD must be the primary disability of the child
- Children will be considered to have ASD if they score above the clinical cutoff or 15 on both the lifetime and current versions of the SCQ. Diagnostic severity of ASD will not be a factor in recruitment.
- Children must be able 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
Key exclusion criteria (3 listed)
- Parents of children with other primary disabilities, or parents who do not have children with ASD 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week FMS Intervention4 sessions, no more than 3 hours per session covering 1) Sensory Integration, 2) Communication, 3) Physical activity, and 4) and Sports (during intervention) | Other | Home-based group, Workshop group |
| Physical Activities & Activity Booklets (via FitFamilies app)Also: Parent workshopsexpected to engage in physical activity at least 3 hours per week, parent workshops provide them with resources to engage in Physical activity | Behavioural | Home-based group, Workshop group, wait-listed home-based group |
Primary outcome
Change in Gross Motor Development as Measured by TGMD-3
Time frame: Baseline, 3 week post intervention (15 weeks)
The Test of Gross Motor Development - second edition (TGMD-3) is a measure of fundamental motor skills. The total possible range of scores is 47-158, where higher scores are indicative of improved gross motor development.
Change in qualitative perceptions of the participants as measured via semi-structured interview.
Time frame: baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks), follow up (24 weeks)
Children will participate in one-on-one semi-structured interviews with the research team to explore their perception regarding communication strategies (between parent and child), patterns of physical recreation, perceived benefits, and constraints.
Change in Social Communication Questionnaire (SCQ)
Time frame: baseline (approximately 2 weeks prior to intervention), post intervention (12 weeks)
The SCQ is a 40-item survey where each question is a 'yes' or 'no' answer. The total possible range of scores is 0-39 (verbal children) or 0-33 (non-verbal children) with higher scores indicative of greater frequency of symptoms.
Change in Parenting Stress Index (PSI)- Short form
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.
Change in Sensory Profile (Dunn 1999)
Time frame: Baseline, 3 weeks post intervention (15 weeks)
The Sensory Profile (Dunn, 1999) is designed to function as a part of a broader assessment of a child's functioning, which may include other observations, history, and diagnostic tests. The parent/caregiver reports the frequency of the behaviors in question, utilizing a Likert scale of always, frequently, occasionally, sometimes, and never. The Sensory Profile consists of 125 items grouped into three main sections: sensory processing, modulation, and behavioral and emotional responses.
Change in the Behavioral Assessment System for Children (BASC-III) (Reynolds & Kamphaus, 2015)
Time frame: Baseline, 3 week post intervention (15 weeks)
To evaluate social behavior, problem behavior, and emotionality of the child. The narrative and scale classifications in this report are based on T scores obtained using norms. Scale scores in the Clinically Significant range suggest a high level of maladjustment. Scores in the At-Risk range may identify a significant problem that may not be severe enough to require formal treatment or may identify the potential of developing a problem that needs careful monitoring.
Change in Adaptive Behavior Assessment System (ABAS-3)
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.
Change in Physical Activity Questionnaire
Time frame: Baseline, weekly throughout the 12 weeks, post intervention (15 weeks)
Parents will be asked to complete a weekly Qualtrics survey inquiring about the type of activities and time they spend participating in those activities. In this survey, parents will comment on the FMS strategies they used or did not use during the week(s).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 37357811Prieto LA, Meera B, Barry A, Swarup G, Asmus J, Ku B, Roth K, Foley JT, Columna L. A randomized parent-mediated physical activity intervention for autistic children. Autism Res. 2023 Jul;16(7):1450-1461. doi: 10.1002/aur.2969. Epub 2023 Jun 26.
- Initial Fit Families Program StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis A Columna, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week FMS Intervention and Physical Activities & Activity Booklets (via FitFamilies app) in people with Autism Spectrum Disorder, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gross Motor Development as Measured by TGMD-3 (time frame: Baseline, 3 week post intervention (15 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05159102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.