I-TEAM Toolkit for Autism Spectrum Disorder

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Not receiving early intervention, others

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 develop a toolkit, called I-TEAM, to assist early intervention (EI) providers in working more effectively with families from diverse cultural backgrounds who have young children with autism. The focus is on ensuring these providers offer culturally responsive support, granting all families equal access to effective practices. The study involves interviews with EI providers to identify factors that help or hinder their use of evidence-based methods. Families who may be a good fit include those from minoritized backgrounds with a young child receiving early intervention services. As an unphased trial, this study allows families to contribute to developing resources that can enhance support for diverse communities.

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 prior data suggests that this toolkit is safe for use in early intervention?

Research shows that treatments for Autism Spectrum Disorder (ASD) are generally safe, particularly those emphasizing early intervention and family support. While specific safety data for the I-TEAM Toolkit is unavailable, similar toolkits have been safely used in schools and developmental programs. These interventions typically involve coaching and training rather than medication or surgery, resulting in a low risk of side effects. The trial is labeled "Not Applicable" in terms of phases, indicating a focus on the toolkit's application and instruction rather than testing a new drug or medical procedure, which usually implies a lower risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-TEAM Toolkit for Autism Spectrum Disorder because it offers a new, comprehensive approach to supporting individuals on the spectrum. Unlike current treatments, which often focus on isolated aspects like behavioral therapy or medication, the I-TEAM provides a holistic set of tools and strategies tailored to each individual’s needs. This method aims to enhance social, communication, and adaptive skills more effectively than existing options by integrating various therapeutic elements into one cohesive program. The potential to customize interventions for greater personal relevance and impact is a key feature that sets the I-TEAM apart from traditional methods.

What evidence suggests that the I-TEAM toolkit is effective for enhancing cultural responsiveness in early intervention for autism?

Research has shown that early intervention for autistic children is effective, particularly when it respects cultural differences. However, many families from marginalized communities struggle to access these proven methods, limiting their benefit from early intervention. The I-TEAM project in this trial aims to address this by training early intervention providers to support families in a culturally respectful manner. Participants in the intervention group will access the I-TEAM, while the waitlist control group will gain access after the intervention group completes the 8-week program. Studies have found that providers with better attitudes and motivation can use these methods more effectively. By focusing on cultural understanding, I-TEAM aims to make early intervention more accessible and beneficial for families from all backgrounds. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Early Intervention (EI) providers over the age of 18 who currently work with marginalized families of young children within Part-C. Participants must be willing to complete the I-TEAM program as instructed.

Inclusion Criteria

Willing to complete I-TEAM as instructed

Currently working with minoritized families of young children within Part-C

I am over 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Intervention group will receive access to the I-TEAM for 8 weeks

8 weeks

Waitlist Control

Waitlist control group will not receive access to the I-TEAM until the Intervention group has completed the 8-week intervention

8 weeks

Follow-up

Participants are monitored for changes in cultural self-efficacy, social validity, and coaching fidelity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• I-TEAM

Trial Overview

The study is testing an implementation toolkit called I-TEAM, designed to enhance culturally responsive evidence-based practices among EI providers working with autistic children from marginalized backgrounds.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Intervention group will receive access to the I-TEAM

Group II: Waitlist control Active Control 1 Intervention

Waitlist control group will not receive access to the I-TEAM until the Intervention group has completed the 8-week intervention.

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

In a study involving 280 caregivers of children aged 6 to 11 on the autism spectrum, it was found that children received a wide range of interventions, with some receiving up to 79.3 hours per week, highlighting the complexity of treatment environments.

Children with higher autism symptom levels and certain demographic factors received more evidence-based interventions, suggesting that these factors should be considered when designing clinical trials for autism treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of Intervention Utilization Among School-Aged Children with Autism Spectrum Disorder: Findings from a Multi-Site Research Consortium. Sridhar, A., Kuhn, J., Faja, S., et al.[2023]

In a 36-month study involving 83 adults with autism spectrum disorder and intellectual disability, it was found that half of the participants were on polypharmacy, taking a median of four medications, primarily antipsychotics.

The study identified 64 adverse events, mostly linked to risperidone, with significant concerns about safety, including unexpected side effects like hypercholesterolemia and rhabdomyolysis, highlighting the need for increased awareness of medication safety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge of detecting adverse events in adults with autism spectrum disorder who have intellectual disability. Ballester, P., Espadas, C., Londoño, AC., et al.[2022]

Remote interventions like the SPAN program can significantly enhance motivation and engagement in autistic adolescents and young adults during intervention processes.

Feedback from 15 stakeholders helped shape adaptations of SPAN for autistic AYA, leading to the development of a new SPAN-ASD website and intervention manual, with plans for future usability testing and pilot studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Participation and Navigation: Formative Evaluation of a Remote Intervention for Autistic Adolescents and Young Adults. Lamash, L., Gal, E., Bedell, G.[2023]

Out of 150 studies on non-medication interventions for young autistic children, only 11 reported any adverse events, highlighting a significant gap in safety reporting in this area of research.

Among the studies that did report on participant withdrawal, 10 identified reasons that could be classified as adverse events, suggesting that researchers need to improve their methods for tracking and reporting these occurrences to better inform families and professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. Bottema-Beutel, K., Crowley, S., Sandbank, M., et al.[2023]

The interdisciplinary review team (IRT) model for monitoring psychotropic medications in children with autism spectrum disorder (ASD) emphasizes a collaborative approach involving medical professionals, behavior analysts, and parents, which aims to standardize treatment effectiveness evaluations.

Case studies showed that this model can lead to successful medication reduction or elimination, highlighting the importance of data-driven decision-making and administrative support in improving treatment outcomes for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotropic Medication Monitoring in a Human Services Organization for Children with Autism Spectrum Disorder: Description and Evaluation of Interdisciplinary Team Review. Bird, F., Harper, JM., Luiselli, JK., et al.[2022]

Adults with autism spectrum disorders (ASD) have significantly higher rates of prescription drug use and polypharmacy compared to adults without ASD, with nearly 75% of those with ASD having over 20 prescription drug claims annually.

The study found that 85% of adults with ASD used at least one psychotropic medication, with common prescriptions including antipsychotics and anticonvulsants, highlighting the need for careful monitoring of treatment efficacy and safety due to the high rates of polypharmacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis. Vohra, R., Madhavan, S., Sambamoorthi, U., et al.[2020]

The implementation of the ASD Care Pathway (ASD-CP) in a public hospital child psychiatric service led to a 40% reduction in the average length of hospital stays for youth with autism spectrum disorder, from 22.4 days to 13.4 days.

Crisis interventions, such as holds and restraints, decreased by 77% after the ASD-CP was implemented, indicating a potential improvement in the management of patients with ASD, although these results approached statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an Autism Spectrum Disorder Care Pathway Improve Care for Children and Adolescents with ASD in Inpatient Psychiatric Units? Kuriakose, S., Filton, B., Marr, M., et al.[2018]

LEND programs across the U.S. provide essential interdisciplinary training for pediatric providers, addressing the growing demand for services for children with developmental disabilities like autism spectrum disorder (ASD).

Data from 22 LEND programs over five years show that trainees significantly improved their knowledge, skills, and attitudes in key areas such as team building and family partnerships, highlighting the effectiveness of these training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Quality Improvement Network for Interdisciplinary Training in Developmental Disabilities. Smith, JD., Nidey, N., Chödrön, GS., et al.[2022]

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TEAM

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sciencedirect.com/science/article/abs/pii/S1750946724001260

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Autism & Safety Toolkit

The first toolkit made by autistic self-advocates, focusing on safety issues that affect us and the tools to deal with them.

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First Responder Toolkit

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Safety Toolkit Resources

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cdc.gov/autism/php/toolkit/index.html

Autism Partner Toolkit | Autism Spectrum Disorder (ASD)

This partner toolkit provides free resources, including links to educational materials on autism. You can share these resources with your friends, family, ...