Evaluating a technique to improve social skills in young children at risk for autism
Evaluating The Efficacy of Pathways Parent-Mediated Intervention's Mutual Gaze Protocol on Social Skills in Young Children Suspected of Having Autism: A Randomized Control Trial
This study is testing a new way to help young children at risk for autism improve their social skills and communication through special sessions that teach them to make eye contact.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 16 Months to 30 Months |
| Sex | All |
| Sponsor | The University of Texas at Dallas Academic / other |
| Locations | 1 site (Richardson, Texas) |
| Trial ID | NCT06596226 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of the 'mutual gaze procedure' as part of the Pathways Early Intervention program in enhancing social communication, language, and everyday skills in children aged 16-30 months who are at high risk for autism. Participants will be randomly assigned to one of two groups: one receiving the intervention with mutual gaze strategies and the other without. The intervention consists of 12 sessions lasting 1.5 hours each, with evaluations conducted at baseline, post-intervention, and three months later to track progress. The study focuses on children from diverse cultural and language backgrounds, ensuring assessments are culturally appropriate.
Who should consider this trial
Good fit: Ideal candidates are children aged 16-30 months who show social communication challenges and are at high risk for autism.
Not a fit: Children outside the age range or those with other known neurological or genetic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve social communication and adaptive skills in young children at risk for autism.
How similar studies have performed: While the specific mutual gaze approach may be novel, similar interventions targeting social skills in young children with autism have shown promising results in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children must be between 16-30 months old at the start of the study; * Children must receive social disability index of 7 or lower on the EarliPointTM assessment with a researcher (i.e., human) confirming social challenges are present; * Parents must report no other known neurological or genetic concerns or disorders * Parents must be fluent in English * Parents must live within a 30-mile radius of the Callier Center Dallas. Exclusion Criteria: * Children younger than 16 months or older than 30 months at the start of the study * Children who are not at high risk for autism based on an EarliPointTM assessment (with researcher confirmation of social challenges) * Children whose parents report they have any other known neurological or genetic concerns or disorders; * Children whose parents are not fluent in English.
Where this trial is running
Richardson, Texas
- University of Texas at Dallas — Richardson, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Pamela Rollins, EdD — The University of Texas at Dallas
- Study coordinator: Pamela Rollins, EdD
- Email: rollins@utdallas.edu
- Phone: 9728833153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.