Training Early Social Language in Autism

NCT03427138 | Unknown

• 1 other identifier: 4190E
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine whether a targeted behavioral intervention can lead to both changes in early communication skills and in neural responses in toddlers and preschoolers with autism.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (9)

• Change in EEG Frequency Data- Resting State

  EEG frequency data as measured during resting state

  Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

• Change in EEG Frequency Data- Grasping Objects

  EEG frequency data as measured while subjects grasps an object

  Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

• Change in EEG Frequency Data- Observing actions

  EEG frequency data as measured while child observes objects grasped and pointed to by others.

  Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

• Change in joint attention measured with the Early Social and Communication scales (ESCS)

  This behavioral assessment follows standardized guidelines to capture the full range of joint attention and behavior request skills (initiate and response). A child has a higher score on the ESCS when they demonstrate behavior requests (e.g. pointing to, or asking for, desired objects), or respond to behavior requests (e.g. giving objects to other people) and joint attention (e.g. three-point gaze). In the ESCS, a higher score would indicate higher social and communication abilities.

  Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

• Change in play level measured with the Structured Play Assessment (SPA)

  Developed by Ungerer \& Sigman (1981), this assessment evaluates the child's number and variety of functional and symbolic play acts when introduced sequentially to 5 toy sets.

  Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

• Change in imitation measured with the Elicited Imitation Battery (adapted from Rogers et al., 2003)

  The child is presented with 3 manual actions (e.g., holding palm up), 3 actions on objects. The child's movements will be coded on a 5-point scale from 0 (no movement) to 5 (imitating all the different experimenter actions).

  Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

• Change in language measured with the Elicitation of Language Sample Assessment-Toddler version (ELSA-T)

  This 15-minute assessment is developed at the Center for Autism Research Excellence at Boston University. It evaluates expressive language abilities of participants.

  Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

• Change in parent-child interactions

  A 10-minute play-based parent-child interaction, using a standard set of age-appropriate toys will be recorded and used as part of the child's expressive language sample.

  Assessment occurs at week 1, week 6, and week 12, with an intervention in weeks 2-11

• Change in predictive gaze measured with eye-tracking

  During the EEG task, eye movements are recorded to assess the child's ability to predict action outcomes.

  Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11

Study Arms (2)

Jasper

EXPERIMENTAL

JASPER (Joint Attention Symbolic Play Engagement Regulation) is a targeted intervention that focusses on early communication skills.

Behavioral: Jasper

Parent Education

EXPERIMENTAL

Parent education intervention focusses on parenting a child with autism.

Behavioral: Parent Education

Interventions

Jasper BEHAVIORAL

Families in the joint attention intervention will receive 10 weeks of the JASPER (Joint Attention Symbolic Play Engagement Regulation) protocol. JASPER is a treatment approach based on a combination of developmental and behavioral principles developed by Dr. Connie Kasari at the Center for Autism Research and Treatment, at University of California, Los Angeles. Our research staff will be trained on the specific techniques of JASPER guided by Connie Kasari (consultant on project) and her colleagues The study's intervention involves 2 days/week of 60-minute sessions with a trained experimenter (which may take place in the lab or home, depending on the needs of the family). The primary goal for the intervention will be to increase the frequency and range/variety of joint attention and to advance the child to higher levels (e.g., from requesting to initiating joint attention acts).

Jasper

Parent Education BEHAVIORAL

Families in the parent education intervention. Parent education will be provided in group sessions. During the sessions information is presented about ASD, how to deal with behavioral difficulties and available services, and parents are given an opportunity to share experiences. Parents will attend a weekly session for 10 weeks. 10 different topics will be discussed, which include: causes and symptoms of autism, diagnosis process, treatment options, enhancing communicative abilities in children with autism, emotion regulation, dealing with distress, correcting behavior difficulties, applying structure and routines.

Parent Education

Eligibility Criteria

• Age: 18 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 18 and 59 months with a confirmed or suspected DSM5 diagnosis of autism spectrum disorder
• The included parents or guardians are required to be the primary caregivers of these children
• Families must speak English in the home at least 75% of the time.

You may not qualify if:

• Seizure disorder (may influence EEG data)
• Gestational age \<32 weeks
• History of serious head trauma
• Genetic syndrome (e.g., fragile X syndrome)

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• University of Maryland, College Park: collaborator
• University of Chicago: collaborator
• Centre National de la Recherche Scientifique, France: collaborator
• University of California, Los Angeles: collaborator
• Boston Medical Center: collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Links

• Lab webpage with information about the study

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Activator Appliances

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Functional; Orthodontic Appliances; Orthodontics; Dentistry; Orthodontic Appliances, Removable

Study Officials

• Helen Tager-Flusberg, PhD

  Boston University Charles River Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychological & Brain Sciences

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 9, 2018
• Study Start: July 1, 2016
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Currently available and continuing indefinitely
• Access Criteria: By request through NDAR

Locations

US (1)