90 Participants Needed

Telehealth vs In-Person Behavior Therapy for Autism

Recruiting at 1 trial location
SH
Overseen ByScott Hall, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Stanford University
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

My child's main caregiver can help with the treatment for 12 weeks.
The child has been diagnosed with ASD (autism) and has a diagnostic report confirming the diagnosis.
I can safely manage my child's difficult behavior during the study.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parent-mediated behavior therapy delivered via telehealth or in-person

4 weeks
Weekly sessions (telehealth or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Parent-Mediated Behavior Therapy
  • Psychoeducation
Trial Overview The study is testing if parent-mediated behavior therapy for kids with ASD can work just as well over telehealth as it does in person. Parents will be trained to help manage their child's challenging behaviors.
How Is the Trial Designed?
3Treatment groups
Active Control
Placebo Group
Group I: In-person treatmentActive Control1 Intervention
Group II: Telehealth-enabled treatmentActive Control1 Intervention
Group III: PsychoeducationPlacebo Group1 Intervention

Parent-Mediated Behavior Therapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Parent-Mediated Behavioral Treatment for:
🇪🇺
Approved in European Union as Parent-Mediated Behavioural Therapy for:
🇨🇦
Approved in Canada as Parent-Mediated Intervention for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Behavior Change Institute

Collaborator

Trials
1
Recruited
90+

Published Research Related to This Trial

In a pilot study involving 27 parents of children with autism spectrum disorders (ASD), those who received therapist-assisted telehealth interventions showed significantly higher engagement and completion rates compared to those using a self-directed approach.
High levels of parent engagement with the ImPACT Online program were linked to improved knowledge and implementation of interventions, suggesting that this telehealth model could effectively support families of children with ASD, especially in rural or underserved areas.
Parent Engagement With a Telehealth-Based Parent-Mediated Intervention Program for Children With Autism Spectrum Disorders: Predictors of Program Use and Parent Outcomes.Ingersoll, B., Berger, NI.[2022]
Telehealth-based parent-mediated interventions (PMIs) for autism spectrum disorder (ASD) have shown promising results, with parents reporting higher knowledge, satisfaction, and compliance compared to standard treatments, based on a systematic review of six studies.
Children receiving these interventions demonstrated improvements in social skills, communication, and intelligence, highlighting the potential of digital approaches in managing ASD, especially during the COVID-19 pandemic.
Managing Autism Spectrum Disorder in the Face of Pandemic Using Internet-Based Parent-Mediated Interventions: A Systematic Review of Randomized Controlled Trials.Yosep, I., Prayogo, SA., Kohar, K., et al.[2022]
Therapist-assisted telehealth interventions significantly improved parent learning compared to self-directed programs, indicating that support from a therapist enhances the effectiveness of parent-mediated strategies for autistic children.
While both intervention types did not significantly reduce parenting stress or improve self-efficacy, parents who completed the program reported a more positive perception of their child's impact, suggesting that engagement is key to realizing benefits from self-directed programs.
Relative Efficacy of Self-directed and Therapist-assisted Telehealth Models of a Parent-mediated Intervention for Autism: Examining Effects on Parent Intervention Fidelity, Well-being, and Program Engagement.Ingersoll, B., Frost, KM., Straiton, D., et al.[2023]

Citations

Effects of Parent-Implemented Interventions on Outcomes ...The findings of this meta-analysis confirmed overall favorable effects of PIIs for children with ASD. Moderately strong improvements in child ...
Meta-analysis of effectiveness of parent-mediated ...For parents of children with ASD, high satisfaction rates were reported, and the interventions led to increased daily living skills in autistic children, ...
Parent-mediated interventions versus usual care in children ...This protocol for a systematic review with meta-analysis aims to describe the methods and purpose of synthesising current evidence regarding the effects
Parent-Mediated Interventions for Children With Autism ...This systematic review suggests that parent-mediated interventions for children with ASD can improve various aspects of communication and ASD symptoms.
Comparative Analysis of Effectiveness of Online Versus ...This research was conducted to compare the effectiveness of online versus in-person parent-mediated interventions in preschool autistic children in resource- ...
Community implementation of a brief parent mediated ...Coaches reported high satisfaction. Toddlers were appropriately identified to receive the intervention. Referral processes improved, including ...
Characteristics of effective parent-mediated interventions ...Outcomes of parent-mediated interventions include long-term symptom reduction, improved prognosis for a wide range of behavioural and brain functions and ...
A parent-mediated intervention to enhance levels of ...We found that children with ASD show improvement in the areas of language, speech, coping strategies & emotions, independence, and social play.
Parent-mediated and Telehealth Intervention for Children ...Clinical trial for Autism Spectrum Disorder , Parent-mediated and Telehealth Intervention for Children With Autism Spectrum Disorder.
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