Engagement + Coaching Intervention for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Autism Spectrum Disorder+2 More
Engagement + Coaching Intervention - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effectiveness of two interventions for Autism Spectrum Disorder: one that engages families and one that coaches families. The trial will be conducted in phases, with the first phase comparing the effectiveness of the two interventions in three sites. The second phase will study the feasibility of implementing the interventions in a new site.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism Spectrum Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Autism Spectrum Disorder

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: Baseline, 3, 6, 9, and 12 months after the start of intervention

Month 12
Autism Diagnostic Observation Schedule (ADOS)
Mullen Scales of Early Learning (MSEL)
Vineland Adaptive Behavior Scales (VABS-3)
Month 12
Child social communication change over time
Observation of DSM-5 features of autism spectrum disorder change over time
Parent contingent responsiveness change over time

Trial Safety

Safety Progress

1 of 3

Other trials for Autism Spectrum Disorder

Trial Design

2 Treatment Groups

Engagement + Coaching Intervention
1 of 2
Engagement Intervention
1 of 2
Active Control

220 Total Participants · 2 Treatment Groups

Primary Treatment: Engagement + Coaching Intervention · No Placebo Group · N/A

Engagement + Coaching Intervention
Behavioral
ActiveComparator Group · 1 Intervention: Engagement + Coaching Intervention · Intervention Types: Behavioral
Engagement Intervention
Behavioral
ActiveComparator Group · 1 Intervention: Engagement Intervention · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3, 6, 9, and 12 months after the start of intervention

Who is running the clinical trial?

Kaiser PermanenteOTHER
504 Previous Clinical Trials
22,193,511 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
470 Patients Enrolled for Autism Spectrum Disorder
Children's Hospital of PhiladelphiaOTHER
644 Previous Clinical Trials
7,847,507 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
8,843 Patients Enrolled for Autism Spectrum Disorder
University of Massachusetts, BostonOTHER
31 Previous Clinical Trials
15,375 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
471 Patients Enrolled for Autism Spectrum Disorder
Boston Medical CenterOTHER
357 Previous Clinical Trials
876,891 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
440 Patients Enrolled for Autism Spectrum Disorder
University of MiamiOTHER
787 Previous Clinical Trials
384,190 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
33 Patients Enrolled for Autism Spectrum Disorder
Boston UniversityOTHER
414 Previous Clinical Trials
10,027,746 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
74 Patients Enrolled for Autism Spectrum Disorder
Florida State UniversityLead Sponsor
156 Previous Clinical Trials
26,804 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
11,335 Patients Enrolled for Autism Spectrum Disorder
Amy Wetherby, PhDPrincipal InvestigatorFlorida State University Autism Institute
2 Previous Clinical Trials
320 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
240 Patients Enrolled for Autism Spectrum Disorder

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.