NCT05604326

Evaluating the Efficacy of Pathways Parent-Mediated Early Autism Intervention on Social Attention and Language

Completed NA Last updated 21 March 2025

What this trial tests

NA trial testing Pathways Intervention in Autism Spectrum Disorder in 58 participants. Completed in 1 February 2025.

Timeline

27 October 2022

Primary endpoint
1 February 2025

1 February 2025

Quick facts

Lead sponsor	The University of Texas at Dallas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	58
Start date	27 October 2022
Primary completion	1 February 2025
Estimated completion	1 February 2025
Sites	1 location across United States

Drugs / interventions tested

• Pathways Intervention
• Parent Education Intervention (PEI)

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

The University of Texas at Dallas

Who can join

Adults 12 Months to 42 Months, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.