Telehealth Support for Autism

Overseen By Meagan Talbott, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: No previous enrollment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how telehealth tools can assist families with infants who might have autism spectrum disorder (ASD). It will test two main tools: TEDI, which evaluates infants' development, and HIIYH (Help is in Your Hands), which provides parents with videos on supporting their child's communication skills. Families will be divided into two groups; one will receive immediate access to the HIIYH materials, while the other will not. Ideal participants are families who have already participated in the earlier TEDI study. As an unphased trial, this study offers families the chance to contribute to innovative research that could enhance early support for infants with ASD.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on telehealth tools and does not mention medication changes.

What prior data suggests that these telehealth tools are safe for families with concerns about ASD?

Research shows that telehealth tools, such as "Help is in Your Hands" (HIIYH), have assisted families with children who have autism. Although specific safety data for HIIYH is unavailable, similar telehealth methods have been positively received. Studies indicate that both families and healthcare providers find telehealth helpful, especially for children with autism in remote areas.

The research does not highlight any major safety issues with using telehealth for autism support. Instead, it emphasizes how well these tools help parents improve their children's communication skills. Since telehealth involves online resources and is non-invasive, it is generally considered safe. This trial focuses on the effectiveness and user-friendliness of these tools, rather than testing a new drug or physical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about "Help is in Your Hands" because it offers a fresh approach to supporting toddlers with autism through accessible telehealth modules. Unlike traditional in-person therapies, which can be costly and time-consuming, this program provides online narrated videos that teach parents interactive strategies to boost their child's communication skills right at home. This innovative delivery method not only empowers parents but also makes support more accessible, potentially reaching families who might otherwise face barriers to receiving care.

What evidence suggests that these telehealth tools are effective for supporting communication development in infants with ASD?

Research has shown that the "Help is in Your Hands" (HIIYH) program, which participants in this trial may receive, can help toddlers develop better communication skills. Studies have found that early support can enhance social and language skills in children with autism. This program provides online lessons with videos that guide parents on interacting with their child to boost communication. Evidence from similar programs suggests that regular use of these methods can improve communication and behavior. Overall, these tools aim to provide parents with practical resources to support their child's development. ^{6 7 8 9 10}

Who Is on the Research Team?

Meagan Talbott, Ph.D.

Principal Investigator

University of California Davis, MIND Institute

Are You a Good Fit for This Trial?

This trial is for families who were previously enrolled in a study evaluating infants' behavioral development (R21 HD100372). It's designed to help those with concerns about Autism Spectrum Disorder (ASD) in their infants by using telehealth tools.

Inclusion Criteria

Previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott)

Exclusion Criteria

No previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment and Randomization

Parents complete online questionnaires and are randomized to receive immediate access to additional online materials or no additional materials

1 week

Online

Intervention

Parents receive access to 'Help is in Your Hands' online materials or no additional materials for 12 weeks

12 weeks

Online

Follow-up

Parents complete online questionnaires and participate in a live telehealth behavioral session with toddlers and caregivers

4 weeks

Online

What Are the Treatments Tested in This Trial?

Interventions

• Help is in Your Hands

Trial Overview

The study tests two telehealth tools: 'Telehealth Evaluation of Development for Infants' (TEDI) and 'Help is in Your Hands' (HIIYH), which provides videos and information to support child communication. Families will be randomly chosen to either receive HIIYH immediately or after 12 weeks.

How Is the Trial Designed?

Group I: HIIYH Experimental Treatment 1 Intervention

Help is in Your Hands is a series of online modules for parents with narrated videos of specific interactive strategies for supporting toddlers' communication development.

Group II: Comparison Active Control 1 Intervention

No additional materials

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

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]

The telehealth system established between the Autism Resource Centre of Brittany and Vannes' Hospital has improved diagnostic precision and support for autistic patients and their families, demonstrating effective collaboration despite geographical distances.

Families reported high satisfaction with the telehealth meetings, which facilitated communication between health professionals and provided timely access to specialized care, while also reducing travel costs and environmental impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Telepsychiatry at the service of autism]. Saint-André, S., Neira Zalentein, W., Robin, D., et al.[2011]

A family-based reporting system for adverse events in pediatric inpatients did not significantly increase the reporting rates by healthcare providers, indicating a disconnect between family and staff perceptions of safety events.

Out of 321 events reported by families, 48% were legitimate safety concerns, highlighting that families can provide valuable insights into patient safety that are often overlooked by healthcare staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification by families of pediatric adverse events and near misses overlooked by health care providers. Daniels, JP., Hunc, K., Cochrane, DD., et al.[2022]

In 2011, the MedWatch system received 600,000 adverse event reports, highlighting its role in improving drug and device safety awareness, but it also faces challenges with reporting bias and data accuracy.

A study analyzing 10.2 million reports found that while patient information was mostly accurate, suspect product data was often incomplete or incorrect, with significant gaps in key details like dosage and product lot numbers, which could lead to incorrect conclusions about drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the completeness and accuracy of MedWatch data. Getz, KA., Stergiopoulos, S., Kaitin, KI.[2017]

Adverse events occurred in 1% of pediatric hospitalizations, with 0.6% being preventable, indicating that a significant number of children experience harm due to medical management rather than their underlying conditions.

The most common types of preventable adverse events were birth-related (32.2%) and diagnostic-related (30.4%), highlighting the need for targeted research and interventions in these areas to improve patient safety in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and preventable adverse events in children. Woods, D., Thomas, E., Holl, J., et al.[2007]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

A survey of 640 caregivers at Cincinnati Children's Hospital Medical Center revealed that 92% were satisfied with telehealth appointments for Psychology and Psychiatry services after the COVID-19 pandemic, indicating high acceptance and effectiveness of this approach.

Despite overall satisfaction, there were significant drops in satisfaction among caregivers of patients in Group Therapy and those with diagnoses classified as 'Other', suggesting areas for improvement in telehealth services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Telehealth Satisfaction Among Caregivers of Pediatric and Adult Psychology and Psychiatry Patients with Intellectual and Developmental Disability in the Wake of Covid-19. Rosen, V., Blank, E., Lampert, E., et al.[2022]

Telehealth services for individuals with autism spectrum disorder (ASD) have been shown to be as effective as traditional face-to-face services, based on a review of 14 studies involving 284 participants ranging from 19 months to adulthood.

The use of telehealth in ASD interventions not only matches in-person services but also outperforms groups that did not receive telehealth, indicating potential benefits for families and educators, though more research is needed for direct applications with children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth and autism: A systematic search and review of the literature. Sutherland, R., Trembath, D., Roberts, J.[2019]

Caregiver training interventions for children with autism can effectively enhance social interaction, communication, and positive behaviors, and these interventions can be successfully delivered via telehealth, showing similar positive outcomes as in-person training.

Telehealth methods offer advantages such as cost-effectiveness and increased accessibility, making them a promising solution to address the global treatment gap for families of children with autism, although further research is needed to evaluate their effectiveness across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth-delivered caregiver training for autism: Recent innovations. Pacione, L.[2023]

Most parents were unaware of the adverse events following immunization (AEFI) surveillance system but expressed interest in participating, indicating a potential for increased reporting through parental involvement.

Parents preferred online reporting over paper forms due to its convenience and speed, and they would be more likely to report AEFI if the website was endorsed by their vaccine provider and offered secure, interactive features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Factors determining utilization of a Web site by parents in order to report side effects of vaccines]. Kimpton, A., Dubé, E., Sauvageau, C., et al.[2021]

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Telehealth Support for Autism · Info for Participants

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This paper evaluates the feasibility of using telehealth to help provide care for children with ASD in remote communities.

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