Autism Spectrum Disorder Clinical Trial
Official title:
Comprehensive Communication Intervention for Minimally Verbal Children With Autism
NCT number | NCT02291172 |
Other study ID # | 141453 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | March 2018 |
Verified date | July 2018 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Overview The goal of Comprehensive Communication Intervention for Minimally Verbal Children with Autism is to conduct an efficacy study of a promising intervention to increase spoken language in preschool children who are minimally verbal. The proposed study compares a comprehensive communication intervention (JASP- EMT Plus; JEP) to a business as usual (BAU) control group in a randomized controlled trial (RCT) across 4 time points. The study replicates and extends procedures used by Kasari, Kaiser et al (2014) to successfully promote social communication in older minimally verbal children. Intervention components include: (1) Joint Attention, Structured Play, Engagement and Regulation and Enhanced Milieu Teaching (JASP- EMT), (2) applied with systematic parent training, (3) use of speech generating device (SGD) and (4) supplementary direct teaching of foundational skills for language learning as indicated by child entry skills (CORE-DTT; Smith, 2009). Children who remain minimally verbal beyond age 5 are at high risk for persistent, severe communication deficits that impact social development, educational achievement and quality of life (Tager-Flusberg & Kasari, 2013). Thus, there is an urgent need for effective strategies to promote communication development during the preschool years to ameliorate early communication deficits and prevent persistent minimally verbal status. This study aims to change social communication in minimally verbal preschool children with ASD by applying a naturalistic social communication intervention which teaches the social foundations of communication and functional use of verbal language in play and interaction. In addition, the intervention addresses three factors that may contribute to remaining minimally verbal: lack of an effective mode of speech production, lack of foundational skills for learning language (receptive language, imitation, joint attention), and lack of communication partners to support continued language learning in natural environments.
Status | Completed |
Enrollment | 74 |
Est. completion date | March 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 36 Months to 54 Months |
Eligibility |
Inclusion Criteria: - A diagnosis of ASD as confirmed by the ADOS - Mental age (MA) of 18 months as measured on the Mullen Scales of Early Learning - Expressive vocabulary of less than 10 - Age between 36 and 54 month - English as the primary language spoken at home - Parents who are willing to participate in parent training. Exclusion Criteria: - Exclusion criteria include any major medical conditions other than ASD, specifically a genetic disorders such as Down syndrome - Sensory disabilities such as blindness or deafness - Motor disabilities such as cerebral palsy. |
Country | Name | City | State |
---|---|---|---|
United States | Metro Nashville Schools | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spontaneous communicative utterances | measured from a naturalistic language sample | 12 weeks |
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