Mind the Gap Intervention for Autism

(MTG Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of various interventions for children and adolescents with autism spectrum disorder (ASD) or other neurodevelopmental disorders (NDD). It tests three approaches: a family support program for young children, a social engagement program for school-age children, and a self-advocacy program for teens, each with and without an additional strategy called UNITED to enhance implementation. The aim is to evaluate the effectiveness of these interventions when combined with a team-based support strategy known as the Mind the Gap intervention. Families with a child aged 2-8 who has ASD or NDD, who are not currently receiving specific services outside of school, and whose income is under 250% of the poverty line may be a good fit. The trial also involves peer navigators and agency staff from community organizations. As an unphased trial, this study offers families the chance to contribute to pioneering research that could shape future interventions for ASD and NDD.

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 these interventions are safe for children and adolescents with autism?

Research shows that the Mind the Gap (MTG) program is well-liked by caregivers. Previous studies found caregivers were satisfied with the program, describing the content as positive and helpful. Feedback from both caregivers and coaches was generally good.

The MTG program helps families learn about autism spectrum disorder (ASD) and guides them in finding services. While no specific negative effects are mentioned, the program is non-invasive and typically low risk. Studies suggest the program is practical and suitable for families. Overall, no major safety issues have been reported for Mind the Gap. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mind the Gap intervention for autism because it emphasizes a team-based approach to implementation in schools and early intervention systems. Unlike traditional methods that may rely on individual practitioners, Mind the Gap encourages assembling a team to plan, assign roles, and support the intervention's rollout and sustainability. This collaborative strategy could enhance the effectiveness and adoption of autism interventions by ensuring ongoing coaching and structured support, potentially leading to more consistent and impactful outcomes for individuals with autism.

What evidence suggests that this trial's interventions could be effective for autism?

Studies have shown that the Mind the Gap program effectively helps caregivers of young children with autism. Research indicates that this program assists caregivers in understanding and navigating the system to obtain necessary services. Previous findings revealed that 78% of participants remained in the program, and coaches delivered 83% of the planned sessions. This suggests that Mind the Gap is both practical and well-received by families. In this trial, participants will join either the UNITED arm, which uses a team-based approach to implementation, or the Implementation as Usual (IAU) arm, where organizations implement Mind the Gap as usual. Overall, evidence supports that Mind the Gap can significantly improve service use for families with newly diagnosed children. ^{1 4 6 7 8}

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

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7487627/

Mind the gap: an intervention to support caregivers with a new ... The goal of Mind the Gap is to engage caregivers of young children with ASD to increase service use. We developed Mind the Gap using principles ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04972825

Study Details | NCT04972825 | AIR-B4: Mind the Gap The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32944273/

Mind the gap: an intervention to support caregivers with a ... Conclusion: Mind the Gap demonstrates evidence of feasibility, and data from the pilot suggest that it addresses intervention engagement ...

4. researchgate.net researchgate.net/publication/344317342_Mind_the_gap_an_intervention_to_support_caregivers_with_a_new_autism_spectrum_disorder_diagnosis_is_feasible_and_acceptable

Mind the gap: an intervention to support caregivers with a ... Retention was high (78%). Coaches could deliver the intervention with fidelity, completing, on average, 83% of program components. Engagement also was high; ...

5. researchgate.net researchgate.net/publication/373511292_Improving_Service_Access_for_Under-resourced_Parents_of_Children_on_the_Autism_Spectrum_a_Randomized_Controlled_Trial

Improving Service Access for Under-resourced Parents of ... Retention was high (78%). Coaches could deliver the intervention with fidelity, completing, on average, 83% of program components. Engagement also was high; ...

6. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT04972825

AIR-B4: Mind the Gap The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determination Learning Model of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9287703/

Using Novel Implementation Tools for Evidence-based ... Mind the gap: an intervention to support caregivers with a new autism spectrum disorder diagnosis is feasible and acceptable. Pilot ...

8. autismspectrumnews.org autismspectrumnews.org/empowering-caregivers-through-an-innovative-peer-navigator-program/

Empowering Caregivers Through an Innovative Peer ... Mind the Gap is an AIR-B project to connect families with support services in their area and to put families with a recent diagnosis in a better position.