Evaluating the Efficacy of Pathways Parent-Mediated Early Autism Intervention on Social Attention and Language

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the efficacy of Pathways parent-mediated early autism intervention (Pathways) and a parent education intervention (PEI) delivered to culturally and linguistically diverse families with children 12-42 months of age suspected of or diagnosed with autism. Question 1: Is Pathways more effective than a PEI at (a) fostering the development of social orienting, joint attention, and social communication and language in children with a research diagnosis of autism and (b) relieving their parents' stress? Question 2: Is the magnitude of the relationship between early and later developing attention greater in children whose parents receive Pathways compared to children whose parents receive PEI? Question 3: Is the magnitude of the relationship between joint attention and social communication and language greater in children whose parents receive Pathways compared to children whose parents receive PEI? Participants will be randomized into 24 weeks of Pathways or PEI. Participants will receive a battery of assessments to evaluate the child's cognitive, social attention, social communication, language, and adaptive functioning, and parental stress at four different time points spaced every 12 weeks from baseline to three-month follow-up.

Official Title
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Evaluating the Efficacy of Pathways Early Autism Intervention on Social Orienting, Joint Attention and Social Language: A Randomized Control Trial

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Pathways Intervention
* Behavioral: Parent Education Intervention (PEI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caregivers and their children who are between 12-42 months old at the start of the study; diagnosed with or suspected of having autism have no other known neurological or genetic concerns or disorders; have a primary home language of English or Spanish; has an ASD diagnosis corroborated by the Autism Diagnostic Observation Schedule (ADOS-2) administered by study researchers; live in Dallas Texas within a 30-mile radius of the downtown location of the UTD/Callier Center for Communication Disorders. Exclusion Criteria: anyone not meeting the inclusion criteria

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 42 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pathways Intervention<br>Twenty-four weeks of a manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated early autism intervention that uses a coaching model. | Behavioral: Pathways Intervention<br>* Pathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers (in English or Spanish) in the family's home or other convenient location. Caregivers will receive a written and audio version of the program manual in English or Spanish, depending on the family's home language. Sessions will review information about autism, interactional strategies, and Applied Behavioral Analysis (ABA) techniques from the program manual, demonstrate intervention strategies, and provide caregivers with practice feedback and self-reflection.<br>|
| Active Comparator: Parent Education Intervention (PEI)<br>Twenty-four weeks of individual caregiver training without the child being present. | Behavioral: Parent Education Intervention (PEI)<br>* Caregivers will access a 20-30-minute video lesson and associated handouts (in English or Spanish, depending on the parent's home language) every other week for 24 weeks. On the off week, the caregiver will meet with a trained clinician (in English or Spanish) for 30 minutes without the child. Lessons will cover autism, social attention delays, evidence-based interventions, self-regulation, talking with your child, playing with your child, principles of managing behavior, knowing your rights, and self-care. The first and last visit will occur in the family's home or another convenient location. All other visits will take place over Zoom videoconferencing software.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in child social orienting | Assessors blind to group and time will code video recordings from two structured clinician-child interactions (CCI). Both CCIs will be recorded using an iPad or small video camera for a wide-angle view of the interaction and hidden camera eyeglasses worn by the clinician to capture the location and direction of the child's eye gaze. Change in the rate of social orienting (number of occurrences/total time engaged with the clinicians across the two structured interactions) will be measured. | Assessed for changes every 12 weeks from baseline to 36 weeks | 
| Changes in child Joint attention | Assessors blind to group and time will code video recordings from two structured clinician-child interactions (CCI). Both CCIs will be recorded using an iPad or small video camera for a wide-angle view of the interaction and hidden camera eyeglasses worn by the clinician to capture the location and direction of the child's eye gaze. Change in the rate of joint attention (number of occurrences/total time engaged with the clinicians across the two structured interactions) will be measured. | Assessed for changes every 12 weeks from baseline to 36 weeks | 
| Change in child social communication | 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. The CSBS-DP is a direct assessment of early social communication. | Assessed for changes every 12 weeks from baseline to 36 weeks | 
| Change in child language | Change in the raw scores obtained on The Preschool Language Scales 5th Edition (PLS-5) will be measured. The PLS-5 is a standardized measure of language. | Assessed for changes every 12 weeks from baseline to 36 weeks | 
| change in intentional communication | Assessors blind to group and time will code video recordings from six minutes of a structured clinician-child interactions using the Early Communication Indicator (ECI). The ECI is a weighted measure of intentional communication. | Assessed for changes every 12 weeks from baseline to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in parenting stress | Change in percentile scores obtained on Parenting Stress Index-4 (PSI-4) will be measured. PSI-4 is a standardized parent questionnaire on which parents rate agreement on 36 items using a five-point Likert scale. | Assessed for changes every 12 weeks from baseline to 36 weeks | 
| changes in child adaptive functioning | Change in raw scores obtained on Vineland Adaptive Behavior Scales, Second Edition (Vineland II) will be measured. The Vineland II is a standardized parent interview to assess adaptive functioning. | Assessed for changes from baseline to 24 weeks and from 24-to-36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Intervention, parent mediated intervention, social orienting, joint attention, social development, social communication, language, parenting stress