Evaluating BOSCC and ELSA as Outcome Measures in the Context of a JASPER Intervention Trial

NCT04146428 | Completed

• 1 other identifier: 19-001638
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 4

Brief Summary

Research teams in Boston University, UCLA, and Weill Cornell will recruit 90 participants in 3 years (10 participants per site per year) and evaluate JASPER, play-based intervention, using the BOSCC and ELSA-T. Participants will be randomized to receive JASPER facilitated either by a clinician or the caregiver. After 10 weeks, the participants will be evaluated using the CGI to determine if they are "responders" or "non-responders". Nonresponders will be given a mix of clinician and caregiver-facilitated JASPER and responders will remain the course for the following 10 weeks. Coding of the BOSCC and ELSA-T will be the outcome measures and change will be evaluated throughout the study.

Conditions

Autism Spectrum Disorder

Keywords

BOSCC; ELSA-T; JASPER; autism

Outcome Measures

Primary Outcomes (2)

• Change in frequency of language utterances and number of conversation turns using the Elicitation of Language Samples for Analysis- Toddlers (ELSA-T)

  Dr. Tager-Flusberg's team created the ELSA, for collecting natural language samples (NLSs) from minimally to low verbal school-aged children and adolescents with ASD and developed a novel approach for deriving quantitative measures of linguistic communication (frequency of child utterances and number of conversational turns), in real-time from the language samples that could be useful for a range of clinical intervention trials. In this study, ELSA will be used on toddlers in this study, which has already been piloted.

  Entry (1st month of the study), T2 (10 weeks after entry), T3 (20 weeks after entry)

• Change in social communication using the Brief Observation of Social Communication Change (BOSCC)

  The BOSCC is a standardized measure of social communication change in children with ASD based on 12-minute videos of clinician- or caregiver-child interactions.

  Entry (1st month of the study), T2 (10 weeks after entry), T3 (20 weeks after entry)

Other Outcomes (7)

• ADOS Toddler Module or Module 1 or Module 2 (depends on child's language level)

  Entry (1st month of the study)

• Determine eligibility on nonverbal mental age using the Mullen Scales of Early Learning (MSEL)

  Entry (1st month of the study)

• Vineland Adaptive Behavior Scale- III

  Entry (1st month of the study)

Study Arms (2)

clinician-mediated JASPER

EXPERIMENTAL

This group will consist of the child and therapist having one-on-one, JASPER sessions, twice a week.

Behavioral: clinician-mediated JASPER

parent-mediated JASPER

EXPERIMENTAL

This group will consist of the therapist assisting the parent implement JASPER on the child twice a week.

Behavioral: parent-mediated JASPER

Interventions

clinician-mediated JASPER BEHAVIORAL

JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the clinician/therapist.

clinician-mediated JASPER

parent-mediated JASPER BEHAVIORAL

JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the parent.

parent-mediated JASPER

Eligibility Criteria

• Age: 18 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Minimally verbal children eligible for the ADOS Toddler Module or Module 1 (pre or minimally verbal) or those who have emerging phrases who may receive Module 2 (phrase speech) will be enrolled. The sample will be limited to children with confirmed diagnosis and nonverbal mental ages greater than or equal to 12 months. The child must be 18 months and 5 years of age.

You may not qualify if:

• Children that do not have a mental age greater than or equal to 12 months, don't have a confirmed diagnosis, are under the age of 18 months and older than 5 years of age.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Simons Foundation: collaborator

Study Sites (4)

UCLA

Los Angeles, California, 90095-1406, United States

Location

Semel Institute

Los Angeles, California, 90095, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Weill Cornell Medical College/New York Presbyterian Hospital

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/PhD

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: April 27, 2021
• Primary Completion: May 14, 2025
• Study Completion: October 28, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)