Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06323850
Other study ID # HM20028878
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date June 15, 2024
Est. completion date February 2025

Study information

Verified date May 2024
Source Virginia Commonwealth University
Contact Stacey Reynolds
Phone 410-241-2140
Email reynoldsse3@vcu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Community mobility is critical for living independently and engaging in one's community. It is especially important for people in their early adult years, as this is often a time of transition to employment and living independently. Community mobility can be particularly challenging for adults with Autism Spectrum Disorders (ASD) (henceforth referred to as autistic adults based on the preferred identity-first language of our autistic partners). Some autistic adults are unable to meet the demands of driving. Public transportation is an option for autistic adults; and autistic adults are more likely to use public transportation than their non-autistic counterparts. However, using public transportation may be just as challenging as driving for the autistic population. Rideshare (also called ride-hailing) is a relatively new form of transportation in which passengers get from point A to point B in private vehicles driven by their owners. A digital app, usually accessed on a smartphone, matches passengers and drivers, coordinates routes using a GPS system, and facilitates payment through a linked financial account. Rideshare has the potential to address many of the issues autistic adults have accessing the community. It is faster and more direct than the public train or bus, there is limited social interaction required, and rides can be scheduled at any time. Despite it's potential to increase transportation in autistic adults, there are no evidence-based training programs to support Rideshare use in this population.


Description:

Rideshare services are widely adopted across the globe and provide a safer, more flexible, and less taxing transportation option for many individuals. Rideshare can help people to get to more places they want to go and allows for spontaneity since a ride can be arranged in the moment, at any time of day. Rideshare picks passengers up and drops them off at their specific destination, eliminating the need to walk to bus stops, wait at stations, or transfer to more than one bus or train. Not only does this save time, it may increase safety especially at night or during inclement weather. Rideshare may also be more reliable for getting to work on time. Finally, while communicating with the driver may be a challenge, there is only one person with which to interact versus potentially many people waiting at stations or on the bus or train. While the use of Rideshare has the potential to improve community access and expand occupational engagement for autistic adults, few training resources exist to introduce clients to this mode of transportation, assess readiness, or build confidence. Our Rideshare training program has proven feasible to conduct with autistic adults living in an urban-based semi-structured independent housing residence. This study will test the effectiveness and implementation of the SRP program in a wider range of autistic adults living in the central Virginia region


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - study participants have to be 18+ years of age - living within 100 miles of Richmond, Virginia - Participants have to have diagnosis of ASD given by a licensed medical professional. - Participants need to have a stable internet connection - ability to communicate independently (verbally or via alternative communication device) in English - have the motoric skills needed to independently use a smartphone (fine motor) and get in and out of a car (gross motor). - Participants must own a smartphone and be familiar with texting and/or email. Exclusion Criteria: - participants who have a severe or profound intellectual disability (IQ below 35) given that the training was designed for those with moderate IQ and above with the potential to travel alone to familiar places - exclude any individual who already uses Rideshare independently. - exclude pregnant women.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention Phase
After participants have been enrolled, they will be assigned to one of the trainer-pairs and will work with them to schedule the first two sessions. Most clients will be able to schedule one virtual session per week and one ride along session per week for the first five weeks, with the remaining three weeks allotted to practice ride-along sessions and module repetition (as needed). The additional time also provides a buffer if subjects are unavailable for a week during the intervention phase.
Virtual Training Sessions
Virtual sessions will take place over Zoom each session lasting 20-30 minutes. Each of the five virtual sessions will be aligned with the five online modules. For each module, exercises are built in to test comprehension. If the participant does not complete an exercise accurately, the lead trainer will explain why the response was incorrect and prompt them to repeat the video modeling exercise. The support training partner will take notes to support the formative assessment process and complete fidelity checks.
Ride-Along Training Sessions
The first ride-along session will be the baseline session for assessing level of independence (number of cues needed) and safety. The participant will have up to 8 ride-along sessions to reach full independence (no cues needed) and full marks on the safety assessment. The lead trainer will provide the cues as needed to complete each step of the Rideshare process.

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University Organization for Autism Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the intervention by conducting an effectiveness-implementation waitlist-controlled trial using our Safe Rideshare Program (SRP) , evaluate autistic adults participating in the SRP intervention find the intervention acceptable? Autistic adults participating in the SRP will rate 75% of the items on the Acceptability Intervention Measure (AIM) as Agree or Completely Agree. The AIM is a 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Acceptability refers to determining how well an intervention will be received by the target population and the extent to which the new intervention or its components might meet the needs of the target population and organizational setting. Baseline and after phase 1 (5 weeks)
Primary Evaluate if the trainers conducting the SRP intervention find the intervention to be appropriate Trainers conducting the SRP intervention will rate 75% of the items on the Intervention Appropriateness Measure (IAM) as Agree or Completely Agree. The AIM is a 5-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Acceptability refers to determining how well an intervention will be received by the target population and the extent to which the new intervention or its components might meet the needs of the target population and organizational setting. Baseline and after phase 1 (5 weeks)
Primary Autistic adults who have participated in the SRP program display greater independence in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group) Autistic adult who have participated in the SRP program will display greater independence in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group) Baseline and after phase 1 (5 weeks)
Primary Autistic adults who have participated in the SRP program display greater safety in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group)? Autistic adult who have participated in the SRP program will display greater safety when using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group) Baseline and after phase 1 (5 weeks)
Secondary In the wait-list group, is there a change in community engagement, social participation, and employment from the waitlist phase (no intervention) to the 2-month follow-up period (after the intervention) There will be a statistically significant change in community engagement, social participation and employment activities between the waitlist phase and 2-month follow-up period. Baseline and after phase 1 (5 weeks) and 3 months post intervention
Secondary How do SRP participants use of Rideshare for community, social, and/or employment activities after the intervention This is an exploratory research question and the investigators will use descriptive statistics and visual analyses to look at trends in how Rideshare is used after participation in the SRP program. The investigators will also gather qualitative data through post-intervention interviews with participants to help determine the impact of the program and what improvements are needed. Baseline and after phase 1 (5 weeks) and 3 months post intervention
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT04167839 - Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement N/A
Terminated NCT04049981 - Investigation of Mechanisms of Action in Superpower Glass Phase 1/Phase 2
Active, not recruiting NCT06080087 - Implementation Toolkit to Enhance EBP Among Marginalized Families N/A
Recruiting NCT04107064 - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program N/A
Completed NCT03206996 - Exposure Therapy for Auditory Sensitivity in Autism N/A
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Completed NCT05588570 - Coaching Children With Anxiety and Autism Through Telehealth N/A
Enrolling by invitation NCT06058104 - Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism N/A
Completed NCT02847182 - Cord Blood Infusion for Children With Autism Spectrum Disorder Phase 2
Completed NCT03002363 - The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance Phase 1
Withdrawn NCT02414451 - Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response N/A
Completed NCT02911194 - a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD) N/A
Completed NCT02508922 - Trial of Vitamin D3 Supplementation in Paediatric Autism N/A
Completed NCT02720900 - Prebiotic Intervention for Autism Spectrum Disorders N/A
Completed NCT02536365 - Sensory Integration Therapy in Autism: Mechanisms and Effectiveness N/A
Completed NCT02708290 - Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Recruiting NCT02255565 - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study Phase 4
Recruiting NCT01836562 - A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism Phase 1/Phase 2
Completed NCT02154828 - Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)