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NCT05604326Completed

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

Evaluating the Efficacy of Pathways Early Autism Intervention on Social Orienting, Joint Attention and Social Language: a Randomized Control Trial

Source: ClinicalTrials.gov · Last updated 21 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
58 (actual)
First submitted
27 Oct 2022
Start date
27 Oct 2022
Primary completion date
1 Feb 2025
Lead sponsor
The University of Texas at Dallas
Diseases
Autism
NCT number
NCT05604326

What you commit to

  • Study type: Interventional
  • Participants enrolled: 58
  • From 27 Oct 2022 to the primary completion date, 1 Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • anyone not meeting the inclusion criteria

Who the study is looking for

  • Caregivers and their children who
  • are between 12-42 months old at the start of the study;
  • diagnosed with or suspected of having autism
  • have no other known neurological or genetic concerns or disorders;
  • have a primary home language of English or Spanish;
  • has an ASD diagnosis corroborated by the Autism Diagnostic Observation Schedule (ADOS-2) administered by study researchers;
  • live in Dallas Texas within a 30-mile radius of the downtown location of the UTD/Callier Center for Communication Disorders.

Age in the registry: 12 months to 42 months · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The University of Texas/Callier Center for Communication Disorders
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.