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

40 Participants Needed

Trial Summary

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 I-TEAM treatment for Autism Spectrum Disorder?

The I-TEAM treatment may benefit from interdisciplinary approaches, as seen in the LEND programs, which improved knowledge, skills, and attitudes in professionals working with developmental disabilities, including autism. Additionally, the ASD Care Pathway showed potential in reducing hospital stays and crisis interventions, suggesting that structured, team-based approaches can enhance care for individuals with autism. ^{1 2 3 4 5}

Is the I-TEAM treatment for Autism Spectrum Disorder safe for humans?

The research highlights concerns about the safety of psychotropic medications often used in autism treatment, noting adverse events like nervous system issues and metabolic problems, especially with drugs like risperidone. It emphasizes the need for careful monitoring and reporting of adverse events to ensure safety. ^{2 6 7 8 9}

How does the I-TEAM Toolkit treatment for Autism Spectrum Disorder differ from other treatments?

The I-TEAM Toolkit for Autism Spectrum Disorder is unique because it likely incorporates information and communication technologies (ICTs) like computers and robots, which are particularly engaging for children with autism. This approach focuses on enhancing social skills through interactive and attractive methods, setting it apart from traditional therapies. ^{10 11 12 13 14}

What is the purpose of this trial?

Although the efficacy of early intervention (EI) for autistic children and their families has been established, many marginalized families with diverse cultural and linguistic backgrounds still report inequitable access to evidence-based practices (EBP). There are several strategies to increase EBP implementation that are especially relevant to marginalized families who report inequitable access to coaching from EI providers, such as increasing the capacity of EI providers to coach families in a culturally responsive way. However, EI providers are provided with limited professional development in both family coaching and cultural responsiveness, which results in perpetuation of EBP implementation failure. Thus, it is crucial to develop and validate an implementation toolkit that comprises strategies to enhance cultural responsiveness in the uptake of EBPs among EI providers. Therefore, the overall purpose of this research is to identify facilitators and barriers of EBP implementation among marginalized families in EI to aid the development an implementation toolkit with a focus on capacity building of EI providers to implement EBP with cultural responsiveness. This will involve conducting individual interviews with EI providers.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

A Quality Improvement Network for Interdisciplinary Training in Developmental Disabilities. [2022]

2. Switzerland 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Patterns of Intervention Utilization Among School-Aged Children with Autism Spectrum Disorder: Findings from a Multi-Site Research Consortium. [2023]

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

Considerations from the 2017 IMFAR Preconference on Measuring Meaningful Outcomes from School-Age to Adulthood. [2019]

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

Does an Autism Spectrum Disorder Care Pathway Improve Care for Children and Adolescents with ASD in Inpatient Psychiatric Units? [2018]

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

Pharmacogenetics May Prevent Psychotropic Adverse Events in Autism Spectrum Disorder: An Observational Pilot Study. [2023]

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

The challenge of detecting adverse events in adults with autism spectrum disorder who have intellectual disability. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. [2023]

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

Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis. [2020]

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

ICT and autism care: state of the art. [2019]

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

Effectiveness of Work, Activities of Daily Living, Education, and Sleep Interventions for People With Autism Spectrum Disorder: A Systematic Review. [2018]

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

SPARK: A US Cohort of 50,000 Families to Accelerate Autism Research. [2023]

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

Social Participation and Navigation: Formative Evaluation of a Remote Intervention for Autistic Adolescents and Young Adults. [2023]

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

Classification of functioning and impairment: the development of ICF core sets for autism spectrum disorder. [2022]