Mind the Gap Intervention for Autism

(MTG Trial)

Recruiting at 3 trial locations

Overseen By Consuelo Garcia, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Health Resources and Services Administration (HRSA)

Disqualifiers: Children under 2 or over 8, others

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

Compensation: Varies

Number of Visits: 12

308 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of Instruction) with and without the addition of an implementation strategy, UNITED. In all groups, the research team will train community practitioners using remote delivery of professional development modules specific to the intervention, and active coaching for up to 12 sessions as dictated by the intervention procedures during a time span of 6 months. The research team will pair UNITED with three interventions that cover the ages of early childhood, childhood, and adolescence. These include Mind the Gap (MTG), a family navigation intervention for children newly diagnosed under age 8, Remaking Recess (RR), a school-based social/peer engagement intervention for children ages 5-12, and Self-Determination Learning Model of Instruction (SDMLI), a self-advocacy intervention for adolescents (13-22 years; 22 is the upper age limit of high school for individuals with disabilities). For MTG, peer navigators (staff working in an organization that already works with parents) and parents (with children with ASD) will meet via phone or video conference for up to 12 sessions within a 6 month span (an hour each time). They will go over sessions that were created by the research group that help parents understand the system of acquiring services. The total time commitment for peer navigators is about 18 hours and for parents with children with ASD is about 8.5 hours. Identified families connected to the community organization will be matched with one peer navigator who will then guide and support the caregiver through completion of the MTG modules with active coaching of the family. Family needs and preferences will guide topic selection. Active coaching will occur via zoom, or over the phone, based on family preference and some recorded sessions will be shared with the research group for analyses. Mind the Gap will be available in English, Spanish, and Korean.

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 safety data exists for the Mind the Gap Intervention for Autism?

Research on interventions for young autistic children often lacks detailed reporting on safety, with only a small number of studies mentioning adverse events or effects. This highlights the need for better methods to track and report any potential negative impacts of such interventions. ^{1 2 3 4 5}

How is the Mind the Gap treatment for autism different from other treatments?

Mind the Gap is unique because it focuses on educating caregivers about autism and helping them navigate services, addressing barriers like mistrust and cultural differences. It uses community partnerships and culturally-informed practices to support families, which is different from traditional treatments that often focus directly on the child. ^{6 7 8 9 10}

What data supports the effectiveness of the Mind the Gap treatment for autism?

The research on early intervention programs for autism, like the Early Start Denver Model, shows that such treatments can improve cognitive, adaptive, and social skills in children with autism. Although Mind the Gap is not specifically mentioned, similar early interventions have demonstrated positive effects, suggesting potential benefits. ^{5 11 12 13 14}

Are You a Good Fit for This Trial?

This trial is for families with children aged 2 to 8 diagnosed with Autism Spectrum Disorder (ASD) or Neurodevelopmental Disorders (NDD), who haven't started ASD-specific services outside of school. Participants must speak English, Korean, or Spanish and have a family income below 250% of the federal poverty level. Peer navigators from community organizations serving children with ASD/NDD are also eligible.

Inclusion Criteria

Agency staff (coordinators, directors, managers, supervisors) working on community organizations with peer navigator capacity

Peer navigators working at participating community organizations with peer navigator capacity

Exclusion Criteria

I do not work in an organization with a peer navigator role and cannot meet the study's requirements.

Peer Navigators: people not working in an organization that has a peer navigator capacity, cannot commit to the times and requirements of the study

Families with children under the age of 2 or over 8 years of age, does not have ASD or NDD, parents are not fluent in English, Spanish, or Korean, child already receiving services accessed with an ASD diagnosis, family income is over 250% federal guidelines for poverty rate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Coaching

Training of peer navigators and active coaching sessions with families over a 6-month period

6 months

Up to 12 sessions (remote)

Implementation

Implementation of Mind the Gap intervention with or without UNITED strategy

6 months

Follow-up

Participants are monitored for effectiveness and satisfaction after intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mind the Gap

Trial Overview The 'Mind the Gap' intervention is being tested, which involves peer navigators helping parents understand how to access services for their child with ASD/NDD through up to 12 sessions over six months via phone or video conference. The effectiveness of additional implementation strategies will also be evaluated.

How Is the Trial Designed?

Group I: UNITED Experimental Treatment 1 Intervention

UNITED is premised on the idea that successful implementation in organizations like schools and early intervention systems requires a team-based approach, in which the team is thoughtfully assembled, develops a plan for implementation, assigns roles and responsibilities, and carefully tracks and supports implementation and sustainment in all its stages within a few meetings and ongoing coaching from the research staff.

Group II: Implementation as Usual (IAU) Active Control 1 Intervention

The organizations will implement Mind the Gap as usual. The research team will be available to provide support on the Mind the Gap intervention as needed.

Who Is Running the Clinical Trial?

Health Resources and Services Administration (HRSA)

Lead Sponsor

Trials

88

Recruited

152,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

Published Research Related to This Trial

Early intervention programs for children with autism have shown positive effects in improving developmental functioning and reducing maladaptive behaviors, based on randomized controlled trials, although the long-term impact on independence and social functioning remains unclear.

Currently, no treatments for early autism meet the highest efficacy standards, with only a few being classified as 'possibly efficacious,' indicating that more rigorous research is needed to identify the most effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based comprehensive treatments for early autism. Rogers, SJ., Vismara, LA.[2022]

The COMPASS intervention, adapted for transition-age youth with autism spectrum disorder (ASD), significantly improved Individualized Education Program (IEP) outcomes compared to a placebo control group, with a large effect size (d = 2.1).

High fidelity in consultant implementation and improved teacher adherence over time highlight the effectiveness of ongoing coaching in enhancing educational outcomes for students with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Control Trial of COMPASS for Improving Transition Outcomes of Students with Autism Spectrum Disorder. Ruble, LA., McGrew, JH., Toland, M., et al.[2020]

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]

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]

Citations

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

Integrating Measurement-Based Care into Treatment for Autism Spectrum Disorder: Insights from a Community Clinic. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Evidence-based comprehensive treatments for early autism. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Implementation of the Early Start Denver Model in an Italian community. [2019]

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

Randomized Control Trial of COMPASS for Improving Transition Outcomes of Students with Autism Spectrum Disorder. [2020]

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

The Autism Impact Measure (AIM): Meaningful Change Thresholds and Core Symptom Changes Over One Year from an Online Survey in the U.S. [2023]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Defining the hidden evidence in autism research. Forty per cent of rigorously designed clinical trials remain unpublished - a cross-sectional analysis. [2021]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Autism spectrum disorder/Takiwātanga: An Integrated Data Infrastructure-based approach to autism spectrum disorder research in New Zealand. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Mind the gap: an intervention to support caregivers with a new autism spectrum disorder diagnosis is feasible and acceptable. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation of a Parent-Mediated Discrete Trial Teaching Intervention for Children with Autism Spectrum Disorder. [2023]

12. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of clinical and cost-effectiveness of the PASS Plus intervention for young children with autism spectrum disorder in New Delhi, India: study protocol for the COMPASS trial. [2023]

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

A global public health strategy for autism spectrum disorders. [2022]

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

Autism Caregiver Coaching in Africa (ACACIA): Protocol for a type 1-hybrid effectiveness-implementation trial. [2023]