Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Autism Spectrum Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 2436 years
Gender
Both males and females

Description

This study will use a Sequential Multiple Assignment Randomized Trial (SMART) design to assess when to examine initial response to treatment, as well as whether and how best to augment the current first line, standard of care intervention for children demonstrating a slower response. First, at progr...

This study will use a Sequential Multiple Assignment Randomized Trial (SMART) design to assess when to examine initial response to treatment, as well as whether and how best to augment the current first line, standard of care intervention for children demonstrating a slower response. First, at program entry, the investigators will assess all toddlers using both standardized and experimental assessments as they enroll in the NYCIT program. After entry assessments, the investigators will randomize each child with equal probability to early response assessment at either six weeks or 12 weeks (timing). This early response assessment will be used to determine whether children are considered fast or slow responders to treatment. Children who are considered early responders will receive a splitting of one on one TA-child JASPER and JasPEER (JASPER including another child peer). Children responding slowly to the initial intervention will be randomized to continue JASPER or to add structured teaching to their JASPER sessions. Approximately 300 toddlers (24-36 months) with a diagnosis of ASD, as confirmed by clinical evaluation records required for placement at the NYCIT will participate. Children will be assessed prior to intervention, immediately after Stage 1(early response) at either six or twelve weeks, exit Stage 2 intervention, and follow up. If teacher/paraprofessional withdraws from the study, all reasonable efforts will be made to place the child with another consenting teacher/paraprofessional. Based on the first two years of trials working with this center, no teacher withdrew mid study. However, a small number of teachers did change positions or took leave (e.g., maternity leave, move for job in another district). In these cases, the child was transferred to another consenting teacher. SMART Design: Initial Randomize to Stage 1 Treatment Stage 1: JASPER (6 weeks) Early Responders/Slow Responders determined Stage 2: JASPER + JasPEER (Early Responders only)-A Slow Responders randomized to Stage 2: Structured Teaching + JASPER -B or Stage 2: JASPER (Randomized for slow responders)-C A, B, and C options occur during the following 18 weeks Exit assessments and Follow up assessments at 3 months post exit Initial Randomized to Stage 1 Treatment Stage 1: JASPER (12 weeks) Early Responders/Slow Responders determined Stage 2: JASPER + JasPEER (Early Responders only)- D Slow Responders randomized to Stage 2: Structured Teaching + JASPER - E or Stage 2: JASPER (Randomized for slow responders)- F D, E, and F options occur during the following 12 weeks

Tracking Information

NCT #
NCT04283045
Collaborators
National Institutes of Health (NIH)
Investigators
Not Provided