Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism

The University of Texas System (UT)

Status: Enrolling

Conditions: Autism

Treatments: Behavioral: Pathways Parent Mediated Intervention; Behavioral: Pathways Parent Mediated Intervention without Mutual Gaze

Study type: Interventional

Funder types: Other

Identifiers

NCT06596226

UTD IRB 24-804

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 30 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups

Pathways with a Mutal Gaze Protocol

Experimental group

Description:

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.

Treatment:

Behavioral: Pathways Parent Mediated Intervention

Pathways without Mutual Gaze Protocol

Active Comparator group

Description:

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.

Treatment:

Behavioral: Pathways Parent Mediated Intervention without Mutual Gaze