What is the mechanism of action of this treatment?

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions such as Applied Behavior Analysis (ABA), the Early Start Denver Model (ESDM), and the SCERTS program. These interventions work by improving social communication, adaptive behaviors, and cognitive functions through structured, individualized programs. Family involvement is crucial, as parent-mediated interventions enhance the effectiveness of these treatments by promoting consistent, supportive interactions at home. This comprehensive approach helps ASD patients by addressing core symptoms, improving daily functioning, and fostering independence, which is essential for their long-term development and quality of life.

What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions, such as the Early Start Denver Model (ESDM) and the Social Communication/Emotional Regulation/Transactional Support (SCERTS) program. These interventions generally have low risk of side effects but may require significant time and effort from families. Complementary and alternative therapies (CAM) like music therapy are also used, which are low risk but have unproven benefits. Pharmacological treatments, though not detailed in the context, can include medications like antipsychotics, which may have side effects such as weight gain, drowsiness, and metabolic changes. It is important for caregivers to work closely with healthcare providers to monitor and manage any potential side effects.

What prior FDA approvals exist?

The FDA has approved medications like risperidone and aripiprazole for the treatment of irritability associated with Autism Spectrum Disorder (ASD). These medications help manage symptoms such as aggression, self-injury, and severe tantrums. While these drugs address behavioral symptoms, the Technology-Enhanced Family Navigation trial focuses on facilitating engagement in mental health and community services, which is more aligned with behavioral and psychological interventions rather than pharmacotherapy. This trial aims to improve access and engagement in supportive services, which is crucial for comprehensive ASD management.

What other types of research exist?

Promising, novel alternatives to Technology-Enhanced Family Navigation for ASD patients include: 1) Immersive Virtual Reality (VR) interventions, which have shown to be safe, feasible, and effective for teaching social skills and police interaction skills to adolescents and adults with ASD. 2) Telehealth delivery of cognitive-behavioral interventions, which has demonstrated feasibility and acceptability for addressing anxiety in youth with ASD. 3) Machine learning models using home videos for early detection and intervention, which can provide early access to care in resource-limited settings.

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Technology-Enhanced Family Navigation for Autism (ATTAIN NAV Trial)

N/A

Waitlist Available

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up distributed at study completion, an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help families of children with autism and additional mental health issues by using specially trained guides called Family Navigators. These guides will use new technology tools to make it easier for families to find and use mental health services. The goal is to ensure that children get the right help quickly and effectively.

Who is the study for?

This trial is for children aged 4-16 with autism, who speak English or Spanish and are getting care at a participating practice. Caregivers of these children can also participate. Healthcare providers must work at the practice and have experience with autistic kids. For part of the study, kids need an official autism diagnosis and show significant symptoms on a checklist.

What is being tested?

The ATTAIN NAV model is being tested to see if it helps families get mental health services faster for their autistic children in primary care settings. It's about adapting family navigation using technology to improve access to care.

What are the potential side effects?

Since this intervention involves technology-enhanced services rather than medication, there aren't typical medical side effects; however, participants may experience increased stress or frustration if they encounter difficulties navigating the system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ distributed at study completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~distributed at study completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and distributed at study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention Measure (AIM)

Appropriateness of Intervention Measure (AIM)

Eyberg Child Behavior Inventory (ECBI)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Stage 3 EnrollmentExperimental Treatment1 Intervention

Addition of 2 clinics with modifications over 4 months including 5 PCPs per clinic (4 total clinics).

Group II: Stage 2 EnrollmentExperimental Treatment1 Intervention

Addition of 2 clinics with modifications over 4 months including 5 PCPs per clinic (4 total clinics).

Group III: Stage 1 EnrollmentExperimental Treatment1 Intervention

Enrollment of 2 clinics over 4 months including 5 PCPs per clinic (2 total clinics).

Group IV: 1 Month Baseline PeriodActive Control1 Intervention

Initial baseline period for rollout at 6 different clinics throughout the year-long intervention period using a step-wedge design.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions such as Applied Behavior Analysis (ABA), the Early Start Denver Model (ESDM), and the SCERTS program. These interventions work by improving social communication, adaptive behaviors, and cognitive functions through structured, individualized programs. Family involvement is crucial, as parent-mediated interventions enhance the effectiveness of these treatments by promoting consistent, supportive interactions at home. This comprehensive approach helps ASD patients by addressing core symptoms, improving daily functioning, and fostering independence, which is essential for their long-term development and quality of life.

Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.Basic science and treatment innovation.