Autism Spectrum DisorderNCT05689541
Development of a Parent-mediated Mobile App Intervention for Parents of Children With Autism Spectrum Disorder Participating in an Adapted Horseback Riding Program
A study testing Mobile app intervention in people with Autism Spectrum Disorder, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this exploratory sequential mixed methods study is to develop and refine a parent-mediated mobile app intervention focused on improving the motor outcomes of children with autism spectrum disorder (ASD) participating in an adapted horseback riding program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Mobile app intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 19 Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: Parents of children with ASD participating in adapted horseback riding sessions at Three Gaits Inc
- Identify as a parent of a child with ASD ages 6-15
- Have access to a mobile device (mobile phone-iOS or android)
- Be willing to download the mobile app on their device
- Be willing to partake in two focus group interviews each for 45-60 minutes over the summer session
- Be willing to complete the end-of-study survey (approximately 20 minutes)
- English-speaking
Inclusion Criteria: Certified Therapeutic Riding Instructors leading the Adapted Horseback Riding sessions at Three Gaits Inc
- Have a certification (certified therapeutic riding instructor) from the Professional Association of Therapeutic Riding (PATH) Intl.
- Minimum 1 year of experience leading/conducting the adapted horseback riding sessions for children with ASD
- English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin- Madison
Madison, Wisconsin, 53705
About this study
Official title: Development and Refinement of a Parent-mediated Mobile App Intervention for Parents of Children With Autism Spectrum Disorder Participating in an Adapted Horseback Riding Program
The purpose of this exploratory sequential mixed methods study is to develop and refine a parent-mediated mobile app intervention focused on improving the motor outcomes of children with autism spectrum disorder (ASD) participating in an adapted horseback riding program.
Read the detailed description
An exploratory sequential design will be used for the development and refinement of the parent-mediated mobile app. In this three-phase mixed-methods research design, priority will be given to the collection and analysis of the qualitative data in the first phase. Building from the exploratory results of the first phase, the investigator will then conduct a development phase to build the mobile-app intervention. Finally, in the third phase, the investigator will quantitatively assess the acceptability of the newly developed mobile-app intervention.
Qualitative phase:
- Focus group discussions with certified therapeutic riding instructors.
- A semi-structured individual interview will be conducted with parents.
During the focus group with certified therapeutic riding instructors and individual interviews with parents, the previously developed Fit Families app will be presented as a model. The focus group discussions and individual interviews for riding instructors and parents respectively, aim to gain an understanding of the content that will be incorporated into the new parent-mediated mobile app.
The technology acceptance model will guide these interviews and focus group discussions and will be conducted for 45-60 minutes. The technology acceptance model is comprised of four constructs: perceived ease of use, perceived usefulness, attitudes, and actual behaviors. Accordingly, the interview and focus group questions will focus on gaining feedback on aspects such as the user interface, time commitment, different types of games, activities, and homework activities prescribed to children with ASD participating in the adapted horseback riding sessions.
After the initial interviews with the parents and certified therapeutic riding instructors, an approximate time of 6 weeks will be assigned for the development phase. Mid-development interviews with therapeutic riding instructors will guide ongoing development and refine the design/games of the mobile app.
During a group 45-60 minute long training session with the major stakeholders (parents and riding instructors), the fully developed version of the "mobile-app intervention" will be presented. The investigator will train the parents on how to use the mobile app and also answer any questions they might have regarding the usage of the app.
The parents will then be instructed to use the app for two weeks. During this usage period, parents will partake in the games and activities of the app with their children with ASD in their home/community settings.
Similarly, during the training session with the certified therapeutic riding instructors, the mobile app will be presented to understand their perceptions and gain feedback on the first full version of the mobile app intervention.
Quantitative phase:
Upon completion of the 2 weeks implementation period of the newly developed mobile app intervention, parents of children with ASD will be provided with a Qualtrics survey to understand the usability of the app. The parents will be asked to complete a System Usability Scale survey within one week of receiving it.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Mobile app intervention
- 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.
Mobile app interventionOther
A mobile-based application will be developed to provide parents with a supplemental curriculum that will include games and activities focusing on motor outcomes. The focus of these games and activities will correspond with the adapted horseback riding program's weekly lesson plan. The mobile app will be created with Glide, which allows us to create a mobile application with basic spreadsheet skills.
The mobile app will aim to incorporate 10-12 games and activities designed to improve specific motor outcomes. Parents will be instructed to partake in the app-delivered activities with their children daily for at least 30-45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Other | Not described Receives: Other: Mobile app intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Exploration of Needs and Perceptions of Participants as measured by Number of Completed Interviews and Focus Group Discussions
The Primary Outcome is to develop a mobile app using qualitative data collected through focus group discussions with therapeutic riding instructors and individual parent interviews; guided by the technology acceptance model. The technology acceptance model is comprised of four constructs: perceived ease of use, perceived usefulness, attitudes, and actual behaviors. Accordingly, the interview and focus group questions will focus on gaining feedback on aspects such as the user interface, time commitment, different types of games, activities, and homework activities prescribed to children with ASD participating in the adapted horseback riding sessions.
Measured: up to 2 weeks on study
Secondary outcomes (1)
Usability of the mobile app as measured by the System Usability Scale Score
The System Usability Scale is the most widely used standardized questionnaire for the assessment of the perceived usability of technology/digital tools. Parents use the app for 2 weeks with their children and fill out this survey by rating on a scale of 1 (strongly disagree) to 5 (strongly agree). The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
Measured: 2 weeks post mobile app implementation period (up to 12 weeks on study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start8 Aug 2022
- Primary completion11 Nov 2022
- Study completion19 Apr 2023
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Columna, Principal investigator, UW-Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689541
- Sponsor's protocol ID
- 2022-0939
- Other IDs
- EDUC/KINESIOLOGY, 10/6/2022
- Status last verified
- May 2023
- First submitted
- 9 Jan 2023
- Last updated
- 26 May 2023
- 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 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Refinement of a Parent-mediated Mobile App Intervention for Parents of Children With Autism Spectrum Disorder Participating in an Adapted Horseback Riding Program
- ClinicalTrials.gov ID
- NCT05689541
- Acronym / sponsor ID
- 2022-0939
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 19 Jan 2023 (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 this exploratory sequential mixed methods study is to develop and refine a parent-mediated mobile app intervention focused on improving the motor outcomes of children with autism spectrum disorder (ASD) participating in an adapted horseback riding program.
Detailed description
An exploratory sequential design will be used for the development and refinement of the parent-mediated mobile app. In this three-phase mixed-methods research design, priority will be given to the collection and analysis of the qualitative data in the first phase. Building from the exploratory results of the first phase, the investigator will then conduct a development phase to build the mobile-app intervention. Finally, in the third phase, the investigator will quantitatively assess the acceptability of the newly developed mobile-app intervention.
Qualitative phase:
- Focus group discussions with certified therapeutic riding instructors.
- A semi-structured individual interview will be conducted with parents.
During the focus group with certified therapeutic riding instructors and individual interviews with parents, the previously developed Fit Families app will be presented as a model. The focus group discussions and individual interviews for riding instructors and parents respectively, aim to gain an understanding of the content that will be incorporated into the new parent-mediated mobile app.
The technology acceptance model will guide these interviews and focus group discussions and will be conducted for 45-60 minutes. The technology acceptance model is comprised of four constructs: perceived ease of use, perceived usefulness, attitudes, and actual behaviors. Accordingly, the interview and focus group questions will focus on gaining feedback on aspects such as the user interface, time commitment, different types of games, activities, and homework activities prescribed to children with ASD participating in the adapted horseback riding sessions.
After the initial interviews with the parents and certified therapeutic riding instructors, an approximate time of 6 weeks will be assigned for the development phase. Mid-development interviews with therapeutic riding instructors will guide ongoing development and refine the design/games of the mobile app.
During a group 45-60 minute long training session with the major stakeholders (parents and riding instructors), the fully developed version of the "mobile-app intervention" will be presented. The investigator will train the parents on how to use the mobile app and also answer any questions they might have regarding the usage of the app.
The parents will then be instructed to use the app for two weeks. During this usage period, parents will partake in the games and activities of the app with their children with ASD in their home/community settings.
Similarly, during the training session with the certified therapeutic riding instructors, the mobile app will be presented to understand their perceptions and gain feedback on the first full version of the mobile app intervention.
Quantitative phase:
Upon completion of the 2 weeks implementation period of the newly developed mobile app intervention, parents of children with ASD will be provided with a Qualtrics survey to understand the usability of the app. The parents will be asked to complete a System Usability Scale survey within one week of receiving it.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Other | Other: Mobile app intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Mobile app interventionA mobile-based application will be developed to provide parents with a supplemental curriculum that will include games and activities focusing on motor outcomes. The focus of these games and activities will correspond with the adapted horseback riding program's weekly lesson plan. The mobile app will be created with Glide, which allows us to create a mobile application with basic spreadsheet skills. The mobile app will aim to incorporate 10-12 games and activities designed to improve specific motor outcomes. Parents will be instructed to partake in the app-delivered activities with their children daily for at least 30-45 minutes. | Other | Single group |
Primary outcome
Qualitative Exploration of Needs and Perceptions of Participants as measured by Number of Completed Interviews and Focus Group Discussions
Time frame: up to 2 weeks on study
The Primary Outcome is to develop a mobile app using qualitative data collected through focus group discussions with therapeutic riding instructors and individual parent interviews; guided by the technology acceptance model. The technology acceptance model is comprised of four constructs: perceived ease of use, perceived usefulness, attitudes, and actual behaviors. Accordingly, the interview and focus group questions will focus on gaining feedback on aspects such as the user interface, time commitment, different types of games, activities, and homework activities prescribed to children with ASD participating in the adapted horseback riding sessions.
1 secondary outcome
Usability of the mobile app as measured by the System Usability Scale Score
Time frame: 2 weeks post mobile app implementation period (up to 12 weeks on study)
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 26 May 2023.
- 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 Columna principal investigator
UW-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 Mobile app intervention 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. 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?
Qualitative Exploration of Needs and Perceptions of Participants as measured by Number of Completed Interviews and Focus Group Discussions (time frame: up to 2 weeks on study). 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 26 May 2023.