Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism
- Conditions
- Autism
- Interventions
- Behavioral: Pathways Parent Mediated InterventionBehavioral: Pathways Parent Mediated Intervention without Mutual Gaze
- Registration Number
- NCT06596226
- Lead Sponsor
- The University of Texas at Dallas
- Brief 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.
- Detailed Description
Purpose of the Study: The primary goal of this clinical trial is to evaluate whether a parent-mediated treatment can improve social communication, language, and adaptive functioning in 16-30-month-old children from diverse cultural and language backgrounds who are at high risk for autism (referred to as children with social challenges).
Study Design:
* Study Phase: N/A
* Intervention Model: Participants are assigned to one of two groups in parallel.
Study Description:
* Participants: 80 children aged 16-30 months who show social communication challenges and are at high risk for autism will be randomly assigned to one of two groups:
1. Group 1: Pathways Intervention with mutual gaze strategies.
2. Group 2: Pathways Intervention without mutual gaze strategies.
* Intervention Sessions: Participants will attend 12 sessions, each lasting 1.5 hours, over approximately 15 weeks (allowing for possible cancellations) of parent-mediated intervention in their homes or another convenient location.
Assessments: To track progress and evaluate long-term effects, participants will undergo several culturally and linguistically appropriate assessments at three time points:
1. Baseline: Within two weeks before starting the intervention.
2. Post-Intervention: Within two weeks after completing the intervention.
3. Three-Month Follow-Up: 12-15 weeks after completing the intervention.
Each evaluation will take around two hours and will include:
* Child Assessments:
* Mullen Scale of Early Learning (MSEL): Assesses general developmental age (administered only at baseline).
* Communication and Symbolic Behavior Scales-Developmental Profile (CSBS-DP): Evaluates social communication.
* EarliPointTM: Measures social, verbal, and nonverbal cognition.
* Caregiver Questionnaires:
* Vineland Adaptive Behavior Scales, Third Edition (VABS-III): Assesses adaptive functioning.
* PhenX Toolkit Core Measures: Collects family and child demographic information, including parents' and grandparents' place of birth (administered only at baseline).
The CSBS-DP and VABS-III have been validated as appropriate measures for determining meaningful changes in children with or at high risk for autism, based on previous research
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pathways with a Mutal Gaze Protocol Pathways Parent Mediated 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. Pathways without Mutual Gaze Protocol Pathways Parent Mediated Intervention without Mutual Gaze 12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version) without the Mutual Gaze protocol. Pathways uses a coaching model.
- Primary Outcome Measures
Name Time Method Improved Social skills 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 Assessors blind to group assignment will evaluate each child for social skills using the EarliPointTM The EarliPointTM is an FDA-authorized eye-tracking tool that uses artificial intelligence (AI) eye-tracking technology to assess social disability in children between 16 and 30 months by measuring the number of social interactions a child observes on the portable eye-tracking screen. EarliTech will be used to measure improved social skills. There are 2 different EarliTech Scores: social disability and Verbal and nonverbal. Social disability scores range from -15 to +25, higher scores indicate better ability. Verbal and nonverbal scores range from 0-90, high scores indicate better ability.
Improved Social Communication Skills 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 Change in the raw scores obtained on the social, speech and symbolic composite of The Communication and Symbolic Behavior Scales- Developmental Profile (CSBS-DP) will be measured. Raw scores for the social, speech and symbolic composite range from 0-64, 0-54 and 0-53 respectively, 0 being the worst score. The CSBS-DP is a direct assessment of early social communication.
Change in Adaptive Functioning 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 The Vineland II is a standardized parent interview to assess adaptive functioning. Change in raw scores obtained on Vineland Adaptive Behavior Scales, Second Edition (Vineland II) will be measured. The Vineland II has 4 domains - Communication, Daily Living, Social Skills and Relationships, Physical Activity. The raw scores for these domains range from 0-252, 0-286, 0-224, 0-154 respectively (lower scores being worse outcomes).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas at Dallas
🇺🇸Richardson, Texas, United States