Pathways Intervention for Autism Spectrum Disorders

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

Study Summary

The goal of this clinical trial is to compare the efficacy of Pathways parent-mediated early autism intervention (Pathways) and a parent education intervention (PEI) delivered to culturally and linguistically diverse families with children 12-42 months of age suspected of or diagnosed with autism. Question 1: Is Pathways more effective than a PEI at (a) fostering the development of social orienting, joint attention, and social communication and language in children with a research diagnosis of autism and (b) relieving their parents' stress? Question 2: Is the magnitude of the relationship between early and later developing attention greater in children whose parents receive Pathways compared to children whose parents receive PEI? Question 3: Is the magnitude of the relationship between joint attention and social communication and language greater in children whose parents receive Pathways compared to children whose parents receive PEI? Participants will be randomized into 24 weeks of Pathways or PEI. Participants will receive a battery of assessments to evaluate the child's cognitive, social attention, social communication, language, and adaptive functioning, and parental stress at four different time points spaced every 12 weeks from baseline to three-month follow-up.

Eligible Conditions
  • Autism Spectrum Disorders
  • Autism Spectrum Disorder

Treatment Effectiveness

Study Objectives

5 Primary · 5 Secondary · Reporting Duration: Assessed for changes from baseline to 24 weeks and from 24-to-36 weeks

Week 36
Change in child language
Change in child social communication
Changes in child Joint attention
Changes in child social orienting
Changes in parenting stress
change in intentional communication
Week 36
Changes in motor skills
changes in child adaptive functioning
changes in cognitive skills
changes in parent responsivity

Trial Safety

Trial Design

2 Treatment Groups

Parent Education Intervention (PEI)
1 of 2
Pathways Intervention
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Pathways Intervention · No Placebo Group · N/A

Pathways Intervention
Behavioral
Experimental Group · 1 Intervention: Pathways Intervention · Intervention Types: Behavioral
Parent Education Intervention (PEI)
Behavioral
ActiveComparator Group · 1 Intervention: Parent Education Intervention (PEI) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed for changes from baseline to 24 weeks and from 24-to-36 weeks

Who is running the clinical trial?

The University of Texas at DallasLead Sponsor
48 Previous Clinical Trials
105,188 Total Patients Enrolled
Pamela R Rollins, Ed.DPrincipal InvestigatorUniversity of Texas at Dallas

Eligibility Criteria

Age < 18 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a student at the University of Texas at Dallas.
You have no other known neurological or genetic concerns or disorders.
You have a primary home language of English or Spanish.
You are between 12-42 months old at the start of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: November 12th, 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.