Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA)

Autism Speaks

Status: Completed

Conditions: Joint Engagement + Enhanced Milieu Training+Augmentative Communication (AAC); Joint Engagement + Enhanced Milieu Training

Treatments: Behavioral: JAE Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01013545

5666 (Other Grant/Funding Number)

G09-04-013-01

Details and patient eligibility

About

This study will contrast two experimental treatment conditions by testing whether joint attention/joint engagement intervention using spoken communication (JAE-EMT) results in better outcomes than joint attention/joint engagement intervention that is instead supplemented with an individualized AAC system (JAE-AAC). Thus, the skills of joint attention/joint engagement (JAE) remain foundational to developing expressive language but the difference in the two treatments will be between whether the JAE is administered through the more traditional spoken means (EMT) or through an augmentative and alternative communication device (AAC).

Full description

Both treatments will be manualized and a novel research design method called Sequential Multiple Assignment Randomized Trial (SMART) will be applied. SMART design will allow the interventionists to adjust the course of treatment based on whether the children respond to the treatment. More specifically, there will be two stages of intervention and during Stage 1, 90 nonverbal (e.g. those who have less than 5 spoken words) children with ASD between 5 and 8 years of age will be randomly assigned to either the JAE-EMT or JAE-AAC group. After receiving the assigned Stage 1 treatment for 12 weeks, all participants will be assessed to see if they responded to the Stage 1 treatment. If the children do respond to Stage 1 treatment, they will continue with that same treatment for another 12 weeks in Stage 2. A different treatment sequence will be used for those who do not respond to Stage 1 treatment where these non-responders will be re-assigned to 1 of 3 alternative intervention conditions. For example, those who do not respond to JAE-AAC will have the intensity of that same JAE-AAC treatment increased. Those who do not respond to the other, JAE-EMT treatment will be randomly assigned to either a more intense JAE-EMT condition, or the original JAE-AAC implemented in Stage 1. At the end of Stage 2, another follow-up assessment of cognitive, language, and social communication skills will be administered. Furthermore, several children who enter the study in the early stages will be tested again, 3 months after the Stage 2 follow up (not all children will be able to be tested at 9 months within the 3 year grant period).

Enrollment: 96 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of autism from a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by Module 1 of the Autism Diagnostic Observation Schedule (Lord et al., 2001)
• Chronological age between 5 and 8 years
• Classified as nonverbal with fewer than 20 spontaneous expressive words as determined by parent report, language sample, and standardized tests.
• Demonstrated slow or no progress in expressive language acquisition despite at least 2 years of early intervention

Exclusion criteria

• Major medical conditions other than autism, specifically: a) motor disabilities such as cerebral palsy or tuberous sclerosis, b) sensory disabilities such as blindness or deafness, and c) genetic disorders such as Fragile X or Down syndrome.
• Nonverbal mental age < 24 months, based on a nonverbal score from the Leiter-R (Roid & Miller, 1997).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

JAE-EMT

Experimental group

Description:

The interventionist will coach the caregiver and child while they engage in play routines established through collaboration between caregiver and interventionist. This intervention condition uses spoken language as the mode of communication. Individual, single word targets will be selected based on the child's level of language production and specific interests. The targets are systematically modeled in response to child actions and attention during play. A sequence of milieu teaching prompts will also be used to elicit targets from the child when use of the target language is functional for the child.

Treatment:

Behavioral: JAE Intervention

JAE-AAC

Experimental group

Description:

The interventionist will coach the caregiver and child while they engage in play routines established through collaboration between caregiver and interventionist. The mode of communication introduced in this intervention condition is a developmentally chosen augmentative communication device. These devices are provided with a set of individually selected visual-graphic symbols and a relevant lexicon. The use of the device is taught within natural communicative exchanges within play routines and daily activities.

Treatment:

Behavioral: JAE Intervention