Telehealth vs In-Person Behavior Therapy for Autism

Recruiting at 1 trial location

Overseen By Scott Hall, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Stanford University

Disqualifiers: Severe behavior, Sensory impairment, Genetic condition, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the research is to determine whether parent-mediated behavior therapy for challenging behavior commonly displayed by children with autism spectrum disorder (ASD) can be as effective when delivered via telehealth as when delivered in-person.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Parent-Mediated Behavior Therapy for Autism?

Research shows that both self-directed and therapist-assisted telehealth parent-mediated interventions can improve language and social skills in children with autism. Therapist-assisted programs may offer additional benefits, such as better parent intervention fidelity and improved social skills in children. ^{1 2 3 4 5}

Is parent-mediated behavior therapy safe for humans?

Parent-mediated behavior therapy, including telehealth versions, is generally considered safe for humans. Studies have shown that parents and children benefit from these interventions, with improvements in skills and satisfaction, and no significant safety concerns have been reported. ^{2 4 6 7 8}

How is Parent-Mediated Behavior Therapy for autism different from other treatments?

Parent-Mediated Behavior Therapy is unique because it involves training parents to deliver therapy to their children, which can be done through telehealth, making it more accessible. This approach empowers parents to be active participants in their child's treatment, potentially improving intervention fidelity and parent-child interactions, especially when therapist assistance is provided. ^{1 2 3 4 9}

Eligibility Criteria

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

The child has been diagnosed with ASD (autism) and has a diagnostic report confirming the diagnosis.

My child's main caregiver can help with the treatment for 12 weeks.

I can safely manage my child's difficult behavior during the study.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: In-person treatment Active Control 1 Intervention

Group II: Telehealth-enabled treatment Active Control 1 Intervention

Group III: Psychoeducation Placebo Group 1 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:

• Autism Spectrum Disorder (ASD) - Challenging Behaviors

Approved in European Union as Parent-Mediated Behavioural Therapy for:

• Autism Spectrum Disorder (ASD) - Challenging Behaviors
• Improvement of Adaptive Functioning

Approved in Canada as Parent-Mediated Intervention for:

• Autism Spectrum Disorder (ASD) - Challenging Behaviors
• Enhancement of Parent-Child Interaction

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+

Findings from Research

Telehealth can effectively train parents in naturalistic teaching strategies to enhance communication skills in children with autism, as demonstrated in a study with five parent-child dyads.

Parents achieved high fidelity in training and reported positive experiences, while children showed variable improvements in communication and increased positive affect, making this approach a cost-effective alternative to traditional training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a telehealth platform on ABA-based parent training targeting social communication in children with autism spectrum disorder. Ferguson, J., Dounavi, K., Craig, EA.[2022]

In a pilot randomized controlled trial involving families of young children with Autism Spectrum Disorder (ASD), both self-directed and therapist-assisted telehealth interventions improved parent skills and perceptions, but the therapist-assisted group showed greater benefits in parent fidelity and positive perceptions of their child.

Children in the therapist-assisted group not only improved in language skills but also showed significant gains in social skills, suggesting that therapist support enhances the effectiveness of parent-mediated interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a Self-Directed and Therapist-Assisted Telehealth Parent-Mediated Intervention for Children with ASD: A Pilot RCT. Ingersoll, B., Wainer, AL., Berger, NI., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 42 children with Autism Spectrum Disorder (ASD) who received a 3-month parent-mediated intervention, all participants showed significant improvements in symptom severity and adaptive functioning at both 3-month and 18-month follow-ups.

At the 18-month follow-up, 16.7% of the children achieved the 'best possible' outcome, with scores indicating they no longer qualified for an ASD diagnosis, highlighting the effectiveness of early intervention in altering developmental trajectories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of children with ASD - Preliminary findings from a 18 month follow up study. Manohar, H., Kandasamy, P.[2021]

Parent-mediated interventions for autism are effective, and remote delivery methods, like telehealth, can successfully reach families during disruptions like the COVID-19 pandemic.

Among different telehealth modalities, video feedback resulted in the highest parental compliance and participation, while psychoeducation had lower compliance and higher drop-out rates, indicating that the type of intervention delivery can significantly impact engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-Feedback Approach Improves Parental Compliance to Early Behavioral Interventions in Children with Autism Spectrum Disorders during the COVID-19 Pandemic: A Pilot Investigation. Aiello, S., Leonardi, E., Cerasa, A., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Parent-mediated interventions can effectively support children with autism spectrum disorder (ASD), but their success varies based on numerous factors related to the child, parent, and study design, as highlighted in a systematic review of 41 articles.

The review identified 45 different factors influencing intervention outcomes, emphasizing the need for improved study quality and consistency in measuring effectiveness to better understand which children benefit most from these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of factors that may influence the outcomes and generalizability of parent-mediated interventions for young children with autism spectrum disorder. Trembath, D., Gurm, M., Scheerer, NE., et al.[2020]

A feasibility trial involving 14 parents of autistic children showed that behavioral parent training (BPT) can be effectively delivered via telehealth, maintaining high fidelity in implementation and receiving positive feedback from participants.

The telehealth format of BPT demonstrated promise in reducing disruptive behaviors in autistic children, improving their adaptive skills, and decreasing parental stress, suggesting it could be a valuable alternative to traditional in-person training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training via Telehealth for Autistic Children: Further Exploration of Feasibility During the COVID-19 Pandemic. Martin, RJ., Crowley-Zalaket, J., Gould, K., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The impact of a telehealth platform on ABA-based parent training targeting social communication in children with autism spectrum disorder. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of a Self-Directed and Therapist-Assisted Telehealth Parent-Mediated Intervention for Children with ASD: A Pilot RCT. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Parent Engagement With a Telehealth-Based Parent-Mediated Intervention Program for Children With Autism Spectrum Disorders: Predictors of Program Use and Parent Outcomes. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical outcomes of children with ASD - Preliminary findings from a 18 month follow up study. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Video-Feedback Approach Improves Parental Compliance to Early Behavioral Interventions in Children with Autism Spectrum Disorders during the COVID-19 Pandemic: A Pilot Investigation. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Managing Autism Spectrum Disorder in the Face of Pandemic Using Internet-Based Parent-Mediated Interventions: A Systematic Review of Randomized Controlled Trials. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Systematic review of factors that may influence the outcomes and generalizability of parent-mediated interventions for young children with autism spectrum disorder. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training via Telehealth for Autistic Children: Further Exploration of Feasibility During the COVID-19 Pandemic. [2023]