NCT05689541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

January 9, 2023

Last Update Submit

May 25, 2023

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Usability of the mobile app as measured by the System Usability Scale Score

    2 weeks post mobile app implementation period (up to 12 weeks on study)

Study Arms (1)

Single group

OTHER
Other: Mobile app intervention

Interventions

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.

Single group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin- Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Luis Columna

    UW-Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 19, 2023

Study Start

August 8, 2022

Primary Completion

November 11, 2022

Study Completion

April 19, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)