Clinical trial NCT06596226: Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism
Official title: Evaluating The Efficacy of Pathways Parent-Mediated Intervention's Mutual Gaze Protocol on Social Skills in Young Children Suspected of Having Autism: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Keywords: Autism Intervention
Social development
Social communication
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: Texas Higher Education Coordinating Board
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: 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
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: University of Texas at Dallas
state: Texas
Study officials:
affiliation: University of Texas at Dallas
name: Pamela Rollins, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anagnostou E, Jones N, Huerta M, Halladay AK, Wang P, Scahill L, Horrigan JP, Kasari C, Lord C, Choi D, Sullivan K, Dawson G. Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder. Autism. 2015 Jul;19(5):622-36. doi: 10.1177/1362361314542955. Epub 2014 Aug 5.
citation: (Anagnostou et al., 2015; Chatham et al., 2018; McCracken et al., 2021).
citation: Chatham CH, Taylor KI, Charman T, Liogier D'ardhuy X, Eule E, Fedele A, Hardan AY, Loth E, Murtagh L, Del Valle Rubido M, San Jose Caceres A, Sevigny J, Sikich L, Snyder L, Tillmann JE, Ventola PE, Walton-Bowen KL, Wang PP, Willgoss T, Bolognani F. Adaptive behavior in autism: Minimal clinically important differences on the Vineland-II. Autism Res. 2018 Feb;11(2):270-283. doi: 10.1002/aur.1874. Epub 2017 Sep 21.
citation: McCracken JT, Anagnostou E, Arango C, Dawson G, Farchione T, Mantua V, McPartland J, Murphy D, Pandina G, Veenstra-VanderWeele J; ISCTM/ECNP ASD Working Group. Drug development for Autism Spectrum Disorder (ASD): Progress, challenges, and future directions. Eur Neuropsychopharmacol. 2021 Jul;48:3-31. doi: 10.1016/j.euroneuro.2021.05.010. Epub 2021 Jun 19.
citation: Mullen, E. M. (1995). Mullen Scales of Early Learning. American Guidance Service, Guilford Press.
citation: Wetherby, A., & Prizant, B. (2002). Communication and Symbolic Behavior Scales- Developmental Profile (1st normed ed.). Paul H. Brookes.
citation: Sparrow, S. S., Cicchetti, D. V., & Saulnier, C. A. (2016). Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). Pearson.