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

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.

Conditions

• Autism Spectrum Disorder

Interventions

BEHAVIORAL

Pathways Intervention

Pathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers (in English or Spanish) in the family's home or other convenient location. Caregivers will receive a written and audio version of the program manual in English or Spanish, depending on the family's home language. Sessions will review information about autism, interactional strategies, and Applied Behavioral Analysis (ABA) techniques from the program manual, demonstrate intervention strategies, and provide caregivers with practice feedback and self-reflection.

BEHAVIORAL

Parent Education Intervention (PEI)

Caregivers will access a 20-30-minute video lesson and associated handouts (in English or Spanish, depending on the parent's home language) every other week for 24 weeks. On the off week, the caregiver will meet with a trained clinician (in English or Spanish) for 30 minutes without the child. Lessons will cover autism, social attention delays, evidence-based interventions, self-regulation, talking with your child, playing with your child, principles of managing behavior, knowing your rights, and self-care. The first and last visit will occur in the family's home or another convenient location. All other visits will take place over Zoom videoconferencing software.

Sponsors & Collaborators

• The University of Texas at Dallas

  lead OTHER

Principal Investigators

• Pamela R Rollins, Ed.D · University of Texas at Dallas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

42 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-27

Primary Completion

2025-02-01

Completion

2025-02-01

Countries

• United States

Study Locations