Telehealth vs In-Person Behavior Therapy for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether behavior therapy for children with autism is as effective via video calls as it is in person. The therapy, called Parent-Mediated Behavior Therapy, helps children who often display aggressive or self-harming behaviors. Families with children aged 2 to 7, living in specific counties in New Mexico and Texas, and experiencing frequent challenging behaviors might be suitable candidates. The study compares in-person therapy, telehealth therapy, and a basic education group to determine which is most effective. Participants need a consistent schedule and reliable cell phone service.
As a Phase 2 and Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. It offers participants a chance to contribute to potentially groundbreaking therapy advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that parent-led behavior therapy is generally safe for children with autism spectrum disorder (ASD). In one study, parents reported high satisfaction with this therapy, noting it helped them better support their children and reduced their own stress. Another study found that this therapy led to lasting improvements in children's language, coping skills, and social play. These results suggest that the therapy is well-tolerated and does not cause significant side effects. While the main focus is on its effectiveness, the available safety information provides confidence in using it for children with ASD.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how parent-mediated behavior therapy for autism can be delivered in innovative ways. Unlike traditional in-person therapy sessions, this trial examines the potential of telehealth-enabled treatment, which can make therapy more accessible by allowing parents and children to engage from the comfort of their own home. This approach could provide greater flexibility and reach for families who have difficulty accessing in-person sessions due to distance or scheduling conflicts. Additionally, comparing telehealth to both in-person therapy and psychoeducation will help determine the most effective method for delivering behavior therapy to children with autism.
What evidence suggests that this trial's treatments could be effective for autism?
Research shows that therapy led by parents can greatly benefit children with autism. In this trial, participants will receive either in-person or telehealth-enabled Parent-Mediated Behavior Therapy. Studies find that in-person sessions often enhance children's communication and daily living skills, with parents reporting high satisfaction. For therapy conducted through telehealth, studies have shown it helps parents better manage their children's behaviors and reduces their stress. Both telehealth and in-person methods have demonstrated positive results, suggesting these approaches can be beneficial regardless of delivery method. Additionally, some participants will receive Psychoeducation as a comparator in this trial.26789
Are You a Good Fit for This Trial?
This trial is for children aged 3 to 5 with Autism Spectrum Disorder (ASD) who show challenging behavior daily. It's also for their English-speaking parents or caregivers, who can manage these behaviors safely and commit to a 12-week treatment program.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Parent-mediated behavior therapy delivered via telehealth or in-person
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Parent-Mediated Behavior Therapy
- Psychoeducation
Parent-Mediated Behavior Therapy is already approved in United States, European Union, Canada for the following indications:
- Autism Spectrum Disorder (ASD) - Challenging Behaviors
- Autism Spectrum Disorder (ASD) - Challenging Behaviors
- Improvement of Adaptive Functioning
- Autism Spectrum Disorder (ASD) - Challenging Behaviors
- Enhancement of Parent-Child Interaction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
United States Department of Defense
Collaborator
Behavior Change Institute
Collaborator