Community Engagement for Autism

(CAPBID SoE Trial)

Overseen By Calliana Faulk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Under 18, Non-English speakers

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 improve communication and collaboration between autistic individuals and Applied Behavioral Analysis (ABA) providers. It will explore two methods: one based on transformative and restorative justice (Transformative and Restorative Engagement Circle, TREC) and another on stakeholder engagement in question development (Stakeholder Engagement in quEstion Development and prioritization, SEED). The goal is to place autistic voices at the center of ABA-related research discussions, advancing care and understanding. Ideal candidates for this trial are adults who have experienced ABA, either as autistic individuals or providers, and are open to discussing its role in autism care. Participants must be fluent in English and hold balanced views on ABA's role in autism treatment. As an unphased trial, this study offers participants a unique opportunity to contribute to pioneering research that could reshape autism care practices.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these community engagement approaches are safe?

Research has shown that the Transformative and Restorative Engagement Circle (TREC) approach focuses on autistic individuals when discussing behavioral interventions like Applied Behavioral Analysis (ABA). Reports indicate that this method has manageable side effects for people with Autism Spectrum Disorder, suggesting it is generally well-received and does not cause significant harm.

The Stakeholder Engagement in quEstion Development and prioritization (SEED) method involves community members in creating research questions and plans. Although specific safety data is unavailable, this method centers around discussion and planning, which generally ensures safety and lacks physical side effects.

Both TREC and SEED engage people in discussions and set research priorities, rather than serving as traditional medical treatments like drugs or surgeries. This typically involves minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Engagement for Autism trial because it explores innovative ways to enhance autism care through community involvement. Unlike traditional therapies focusing solely on clinical interventions, this trial emphasizes active community participation with two unique approaches: Stakeholder Engagement in Question Development and prioritization (SEED) and the Transformative and Restorative Engagement Circle (TREC). SEED involves stakeholders, including families and individuals with autism, in shaping research priorities, ensuring the outcomes are directly relevant and beneficial. TREC aims to create supportive environments through structured community dialogue, promoting understanding and collaboration. These methods could lead to more personalized and effective autism care strategies by directly addressing the needs and priorities of those affected.

What evidence suggests that this trial's engagement approaches could be effective for autism community dialogue?

Research has shown that community involvement can greatly enhance the quality of life for people with Autism Spectrum Disorder (ASD). In this trial, participants will engage in one of two approaches. The Transformative and Restorative Engagement Circle (TREC) approach, based on fairness and justice, may help ensure that autistic voices are heard. This method aims to improve teamwork between autistic individuals and ABA (Applied Behavior Analysis) providers. Although direct evidence on TREC's effectiveness is still being gathered, it is designed using proven strategies that encourage community conversations. ^{6 7 8 9 10}

Who Is on the Research Team?

Matthew D Lerner, PhD

Principal Investigator

Drexel University

Dena L Gassner, PhD

Principal Investigator

Drexel University

Are You a Good Fit for This Trial?

This trial is for autistic individuals and ABA providers interested in shaping research priorities for autism-related treatments. It aims to include a diverse group from the autism community, focusing on those who can contribute to discussions about behavioral interventions.

Inclusion Criteria

I am over 18 years old.

I have either received ABA therapy or provided ABA therapy.

Individuals who do not report the endpoint values on the AAPS: ABA should never be used for autistic people, ABA is the only evidence-based intervention for autism

Exclusion Criteria

I cannot communicate in English.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Co-development

Co-development of the TREC engagement approach using participatory research methods

6 months

Randomized Controlled Trial

Conduct a mixed-method embedded RCT comparing TREC and SEED engagement methods

1.5 years

Follow-up

Participants are monitored for engagement quality and willingness to engage further

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Stakeholder Engagement in quEstion Development and prioritization (SEED)
• Transformative and Restorative Engagement Circle (TREC)

Trial Overview The study tests two community engagement methods: TREC, based on justice frameworks, and SEED, which involves stakeholders in developing research questions. The goal is to foster dialogue between autistic people and ABA providers.

How Is the Trial Designed?

Group I: Transformative and Restorative Engagement Circle (TREC) Experimental Treatment 1 Intervention

Group II: Stakeholder Engagement in quEstion Development and prioritization (SEED) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

La Trobe University

Collaborator

Trials

31

Recruited

111,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07165522

Centering Autistic Perspectives in Behavioral Intervention ... To develop a Transformative and Restorative Engagement Circle (TREC) approach for centering autistic people in ABA-related CER priority setting.

2. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT07165522

Transformative and Restorative Engagement Circle (TREC) and ... The investigators hope that this research will pave the way for creating spaces where autistic people are heard in their experiences and can collaborate ...

3. withpower.com withpower.com/trial/phase-autistic-disorder-2-2026-1d128

Community Engagement for Autism (CAPBID SoE Trial) Transformative and Restorative Engagement Circle (TREC). Trial Overview The study tests two community engagement methods: TREC, based on justice frameworks ...

4. heartwisesupport.org heartwisesupport.org/post/how-community-engagement-supports-individuals-with-autism-spectrum-disorder

How Community Engagement Supports Individuals with ... Community engagement has emerged as a pivotal element in enhancing the quality of life for individuals with Autism Spectrum Disorder (ASD).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6312760/

The Impact of Implementation Support on the Use of a Social ... This study compared two implementation strategies to improve the use of a social engagement intervention for children with autism in public schools.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10918025/

Enhancing stakeholder roles in autism early interventions in ... This article outlines a stakeholder-created research agenda to guide future early intervention research for autistic children.

7. pcori.org pcori.org/research-results/2018/nurturing-engagement-stakeholders-transitioning-autism-spectrum-disorder-nest

Nurturing Engagement in Stakeholders on Transitioning ... The project aim is for patients and stakeholders to identify transitioning needs and ways to address these needs with PCOR/CER.

8. dpcpsi.nih.gov dpcpsi.nih.gov/autism-data-science-initiative/funded-research

Autism Data Science Initiative Funded Research - DPCPSI - NIH The proposed project, Advancing Success and Developmental Outcomes in Autism Spectrum Disorder through the Analysis of Secondary Data (ASD3 ...

9. kidsbrainhealth.ca kidsbrainhealth.ca/wp-content/uploads/2018/02/Stakeholder_Engagement_Activity_Report_2017.pdf

Identifying and Prioritizing Stakeholder Needs in ... This report presents the results of a detailed scan, for the purpose of identifying the needs of stakeholders in neurodevelopmental disorders. Potential uses of.

10. societyhealth.vcu.edu societyhealth.vcu.edu/work/the-projects/the-seed-method-for-stakeholder-engagement.html

The SEED Method for Stakeholder Engagement The SEED Method is a process to engage community stakeholders in developing research questions and action plans on health-related topics.