Clinical trial NCT05604326: Evaluating the Efficacy of Pathways Parent-Mediated Early Autism Intervention on Social Attention and Language
Official title: Evaluating the Efficacy of Pathways Early Autism Intervention on Social Orienting, Joint Attention and Social Language: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Intervention
parent mediated intervention
social orienting
joint attention
social development
social communication
language
parenting stress
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study aims to evaluate the efficacy of all ten units of Pathways parent-coaching early autism intervention. A limitation of our previous 12-week intervention research was that in 12 weeks, we could only assess efficacy for the first five Pathways units. The first five units focus on dyadic social skills (i.e., social orienting, mutual gaze, getting the social partner's attention, and mutual imitation). The last five Pathways units (units 6-10) build on these foundational skills and focus on facilitating triadic social skills (i.e., joint attention, social communication, and language). Joint attention is an essential component of social communication and provides the context for social communication and language. Therefore, it is vital to establish the efficacy of the entire Pathways program (i.e., all ten units) on the development of social orienting, joint attention, social communication, and language.

Aim 1: To identify the effectiveness of the entire Pathways program on (a) 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.

Aim 2: To identify the relationship between early social orienting and later joint attention, social communication, and language skills.

We hypothesize that Pathways will moderate the effect of (1) growth in social orienting after receiving 12 weeks of intervention and (2) growth in joint attention and social communication and language after receiving 24 weeks of intervention. Further, we hypothesize social orienting after 12 weeks of intervention is significantly related to joint attention at 24 weeks. Finally, we expect that joint attention at 24 weeks will be significantly related to language at 36 weeks (i.e., at a 3-month follow-up). In terms of parenting stress, we expect to find a significant effect of Pathways on decreasing parent stress during the first 12 weeks of intervention, followed by a plateau.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in child social orienting
timeFrame: Assessed for changes every 12 weeks from baseline to 36 weeks
measure: Changes in child Joint attention
timeFrame: Assessed for changes every 12 weeks from baseline to 36 weeks
measure: Change in child social communication
timeFrame: Assessed for changes every 12 weeks from baseline to 36 weeks
measure: Change in child language
timeFrame: Assessed for changes every 12 weeks from baseline to 36 weeks
measure: change in intentional communication
timeFrame: Assessed for changes every 12 weeks from baseline to 36 weeks
Secondary outcomes:
measure: Changes in parenting stress
timeFrame: Assessed for changes every 12 weeks from baseline to 36 weeks
measure: changes in child adaptive functioning
timeFrame: Assessed for changes from baseline to 24 weeks and from 24-to-36 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas/Callier Center for Communication Disorders
state: Texas
Study officials:
affiliation: University of Texas at Dallas
name: Pamela R Rollins, Ed.D
role: PRINCIPAL_INVESTIGATOR
References: