Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism (NCT06596226) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism
United States80 participantsStarted 2024-09-10
Plain-language summary
Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure," used in Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism, particularly those from diverse cultural and language backgrounds.
What Will Happen: Researchers will compare two versions of the Pathways Intervention:
* Version 1: Includes mutual gaze strategies.
* Version 2: Does not include mutual gaze strategies.
What to Expect: Participants will:
* Attend 12 sessions of Pathways Intervention, each lasting 1.5 hours (or 15 weeks if there are cancellations).
* Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.
Who can participate
Age range
16 Months – 30 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 if child is 16-20 months old, or 8.1 or lower if child is 21-30 months old 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 or Spanish
* Parents must live within a 30-mile radius of the Callier Center Dallas or Callier Center Richardson.
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 or Spanish
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improved Social skills
Timeframe: 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
2
Improved Social Communication Skills
Timeframe: 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
3
Change in Adaptive Functioning
Timeframe: 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