Autism Spectrum DisorderNCT04612647
Fit Families Program: Fundamental Motor Skill Intervention in Children With Autism Spectrum Disorders and Their Parents
A study testing 12-week FMS Intervention and Physical Activities & Activity Booklets in people with Autism Spectrum Disorder, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The investigators aim 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 and a variety of other factors (child behaviors, communication, and adaptive skills) and to identify patterns… 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2020to 24 May 2020
- 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
The investigators aim 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 and a variety of other factors (child behaviors, communication, and adaptive skills) and 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.
Read the detailed description
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 and physical education-related activity items (e.g., ball, hoop). The hypothesis is 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.
Note: Due to COVID-19 for the post-test, instead of parents attending the UW-Facilities, they will be asked to videotape themselves and their children while performing the test of gross motor development (TGMD) activities. For the follow-up test (Fall 2020) we will expect to conduct these in person. However, if the situation due to COVID-19 remains the same, the investigators will ask families to follow the same procedures (videotape themselves and their children).
- Conditions
- Autism Spectrum Disorder
- Being tested
- 12-week FMS Intervention, Physical Activities & Activity Booklets
- 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) Aquatic Opportunities, and 4) Physical activity and Sports (during intervention)
Physical Activities & Activity BookletsBehavioural
expected to engage in physical activity at least 3 hours per week
| 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) Aquatic Opportunities, and 4) Physical activity and Sports (during intervention)-[Parents and Children-Workshop Group]. In addition to the workshops, this group and the home-based group will receive information (activity booklets) and physical education (physical activity)-related equipment. Receives: Other: 12-week FMS Intervention; Behavioral: Physical Activities & Activity Booklets |
| Home-based group | Experimental | Participants in the home-based group will not participate in the four half-day workshops, but they will receive the same information (activity booklets) and physical activity equipment as the workshop group (during intervention)-[Parents and Children-Home Group]. Receives: Behavioral: Physical Activities & Activity Booklets |
| wait-listed home-based group | No intervention | 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 and 3 months after the completion of the 12-week period. Immediately following the follow-up test (3 months after the intervention), 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. |
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), 3 months post intervention (24 weeks)
Number of Participants Whose Perceptions Qualitatively Improve 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)
Fidelity of Intervention reported as Number of Parents who Implements the Intervention as Intended
Fidelity checklists will be used to determine the fidelity of the intervention. Parents will be asked to email a video of 1-2 lessons per week along with a completed task analysis checklist. Parents will be asked to confirm whether or not each task was completed on the checklist. The research team will complete the same form while viewing the video to ensure whether the parent knows and is implementing the steps intended and if there are fidelity differences between the workshop and home-based group.
Measured: up to 12 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start2 Jan 2020
- Primary completion24 May 2020
- Study completion24 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 41 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
- NCT04612647
- Sponsor's protocol ID
- 2019-1256
- Other IDs
- A176000, EDUC/KINESIOLOGY/KINESIO
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. 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
- NCT04612647
- Acronym / sponsor ID
- 2019-1256
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 24 May 2020 (actual)
- Study completion
- 24 May 2020 (actual)
- First posted
- 3 Nov 2020 (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 investigators aim 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 and a variety of other factors (child behaviors, communication, and adaptive skills) and 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.
Detailed description
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 and physical education-related activity items (e.g., ball, hoop). The hypothesis is 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.
Note: Due to COVID-19 for the post-test, instead of parents attending the UW-Facilities, they will be asked to videotape themselves and their children while performing the test of gross motor development (TGMD) activities. For the follow-up test (Fall 2020) we will expect to conduct these in person. However, if the situation due to COVID-19 remains the same, the investigators will ask families to follow the same procedures (videotape themselves and their children).
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 BookletsParticipants in the workshop group will be offered four one-day workshops (3-hours each) covering topics of 1) Sensory Integration, 2) Communication, 3) Aquatic Opportunities, and 4) Physical activity and Sports (during intervention)-[Parents and Children-Workshop Group]. In addition to the workshops, this group and the home-based group will receive information (activity booklets) and physical education (physical activity)-related equipment. |
| Home-based group | Experimental | Behavioral: Physical Activities & Activity BookletsParticipants in the home-based group will not participate in the four half-day workshops, but they will receive the same information (activity booklets) and physical activity equipment as the workshop group (during intervention)-[Parents and Children-Home Group]. |
| wait-listed home-based group | No intervention | –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 and 3 months after the completion of the 12-week period. Immediately following the follow-up test (3 months after the intervention), 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) Aquatic Opportunities, and 4) Physical activity and Sports (during intervention) | Other | Workshop group |
| Physical Activities & Activity Bookletsexpected to engage in physical activity at least 3 hours per week | Behavioural | Home-based group, Workshop group |
Primary outcome
Change in Gross Motor Development as Measured by TGMD-3
Time frame: Baseline, 3 week post intervention (15 weeks), 3 months post intervention (24 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.
Number of Participants Whose Perceptions Qualitatively Improve 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.
Fidelity of Intervention reported as Number of Parents who Implements the Intervention as Intended
Time frame: up to 12 weeks
Fidelity checklists will be used to determine the fidelity of the intervention. Parents will be asked to email a video of 1-2 lessons per week along with a completed task analysis checklist. Parents will be asked to confirm whether or not each task was completed on the checklist. The research team will complete the same form while viewing the video to ensure whether the parent knows and is implementing the steps intended and if there are fidelity differences between the workshop and home-based group.
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.
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 3 Nov 2020.
- Individual participant dataSharing planned: No
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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 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 3 Nov 2020. 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), 3 months post intervention (24 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.