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Development of a Parent-mediated Mobile App Intervention for Parents of Children With Autism Spectrum Disorder Participating in an Adapted Horseback Riding Program

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile app intervention
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin- Madison

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 9, 2023
Last Updated
May 25, 2023
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT05689541
Brief Title
Development of a Parent-mediated Mobile App Intervention for Parents of Children With Autism Spectrum Disorder Participating in an Adapted Horseback Riding Program
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
April 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Mobile app intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Qualitative Exploration of Needs and Perceptions of Participants as measured by Number of Completed Interviews and Focus Group Discussions
Description
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.
Time Frame
up to 2 weeks on study
Secondary Outcome Measure Information:
Title
Usability of the mobile app as measured by the System Usability Scale Score
Description
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.
Time Frame
2 weeks post mobile app implementation period (up to 12 weeks on study)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Columna
Organizational Affiliation
UW-Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin- Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development of a Parent-mediated Mobile App Intervention for Parents of Children With Autism Spectrum Disorder Participating in an Adapted Horseback Riding Program

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