Pathways Mutual Gaze Protocol for Autism

N/A

Recruiting

Led By Pamela Rollins, EdD

Research Sponsored by The University of Texas at Dallas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Children must be between 16-30 months old at the start of the study;

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (i.e., within two weeks prior to the start of intervention); post-intervention (i.e., within two weeks after completing the intervention); at three-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a technique called the "mutual gaze procedure" can help improve social communication, language, and everyday skills in young children at high risk for autism. The study will compare

Who is the study for?

This trial is for young children aged 16-30 months who are at high risk for autism and have social challenges, with parents fluent in English. It's aimed at those living within 30 miles of the Callier Center Dallas without other neurological or genetic disorders.

What is being tested?

The study tests two versions of Pathways Early Intervention to improve social skills in kids suspected of autism: one includes mutual gaze techniques, while the other doesn't. Participants will attend sessions and have developmental check-ups before, after, and three months post-intervention.

What are the potential side effects?

Since this intervention involves behavioral strategies rather than medication, traditional side effects are not expected. However, there may be variations in individual responses to therapy based on child temperament and family dynamics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 16 and 30 months old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (i.e., within two weeks prior to the start of intervention); post-intervention (i.e., within two weeks after completing the intervention); at three-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (i.e., within two weeks prior to the start of intervention); post-intervention (i.e., within two weeks after completing the intervention); at three-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (i.e., within two weeks prior to the start of intervention); post-intervention (i.e., within two weeks after completing the intervention); at three-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Adaptive Functioning

Improved Social Communication Skills

Improved Social skills

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pathways with a Mutal Gaze ProtocolExperimental Treatment1 Intervention

12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version). Pathways uses a coaching model.

Group II: Pathways without Mutual Gaze ProtocolActive Control1 Intervention

0 / 1Eligibility criteria met