Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05689541
Other study ID # 2022-0939
Secondary ID EDUC/KINESIOLOGY
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2022
Est. completion date April 19, 2023

Study information

Verified date May 2023
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date April 19, 2023
Est. primary completion date November 11, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mobile app intervention
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.

Locations

Country Name City State
United States University of Wisconsin- Madison Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 2 weeks on study
Secondary 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. 2 weeks post mobile app implementation period (up to 12 weeks on study)
See also
  Status Clinical Trial Phase
Completed NCT05207956 - App for Strengthening Services In Specialized Therapeutic Support N/A
Completed NCT03286621 - Development of Eye-tracking Based Markers for Autism in Young Children
Completed NCT02608333 - Efficiency of Early Intervention for Autism Spectrum Disorder N/A
Recruiting NCT05935722 - Evaluation of a Home-based Parenting Support Program: Parenting Young Children N/A
Active, not recruiting NCT06259539 - A YouTube Curriculum for Children With Autism and Obesity N/A
Active, not recruiting NCT06303791 - Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders N/A
Enrolling by invitation NCT05017779 - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth N/A
Completed NCT04772898 - Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder N/A
Recruiting NCT04987541 - The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder N/A
Completed NCT04308915 - Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders N/A
Completed NCT06038435 - The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder N/A
Terminated NCT04049981 - Investigation of Mechanisms of Action in Superpower Glass Phase 1/Phase 2
Completed NCT03693313 - The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP) N/A
Recruiting NCT04107064 - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program N/A
Recruiting NCT03812068 - Parent-mediated Developmental Behavioral Intervention N/A
Completed NCT03206996 - Exposure Therapy for Auditory Sensitivity in Autism N/A
Completed NCT02299700 - Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder N/A
Completed NCT03422016 - Electroretinogram in Autistic Spectrum Disorders
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Recruiting NCT05114538 - Improving the Part C Early Intervention Service Delivery System for Children With ASD N/A