Comprehensive Communication Intervention for Minimally Verbal Children With Autism
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|ClinicalTrials.gov Identifier: NCT02291172|
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Intervention JEP||Not Applicable|
The proposed project is a randomized control design study testing the effectiveness of a comprehensive communication intervention to improve spoken language and social communication, and to reduce the portion of children with autism who are minimally verbal at age 5. The intervention (JASP-EMT-Plus; JEP) includes four components which have been shown to be effective in improving outcomes for older children with ASD who are minimally verbal. These components are (a) direct teaching for foundational language skills, (b) systematic introduction of an SGD paired with spoken language; (c) A naturalistic communication intervention: Joint Attention, Structured Play, Engagement and Regulation and Enhanced Milieu Teaching (JASP-EMT); and (d) parent training to support and generalize newly learned communication skills.
Following comprehensive assessment linking children's extant communication skills to the skills taught in each intervention component, an adapted treatment protocol will be developed for each child within the framework of the comprehensive treatment model. A total of 97 children ages 36 to 54 months will be randomly assigned to the treatment or a BAU control group. Progress in treatment will be monitored throughout the 3-month (42 session) intervention. Children will be assessed at 4 time points: pre intervention, post- intervention, 2 months, and 4 months after intervention. The data collected in this randomized trial will provide: (1) evidence of effectiveness for a comprehensive communicative intervention for improving communication in minimally verbal children with autism; and (2) new information about the correlates of minimal verbal status in children with autism.
Aim. To examine the effects of JEP on social communication (primary outcome) RQ1: Do young children with ASD who receive JEP produce significantly more social communicative utterances (proximal) in language samples, social communication on standardized assessment (distal), and expressive language on standardized assessment (distal) than children in the BAU group at T2 (immediately following intervention)?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comprehensive Communication Intervention for Minimally Verbal Children With Autism|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||March 2018|
Experimental: Intervention JEP
A blend of JASP-EMT using SGDs with parent training intervention with the addition of individualized DTT to teach receptive language, imitation, and joint attention when children lack these skills at entry. The comprehensive communication intervention: (a) teaches foundational social communicative behaviors, (b) related skills that predict long term language outcomes, (c) a range of communicative functions, (d) spoken language skills, (e) provides children with an immediate mode of communication, (f) incorporates instructional methods, contexts, and partners that increase both the critical skills for spoken language and social use of language. Because parents are essential partners for young children with ASD who are learning to communicate, we (g) include parents
Behavioral: Intervention JEP
A blend of JASP-EMT using SGDs with parent training intervention with the addition of individualized DTT to teach receptive language, imitation, and joint attention when children lack these skills at entry.
No Intervention: Business as Usual Control Group
All children, regardless of group assignment will participate in all assessments. Children randomized to the control group will not receive intervention, but will complete all other research procedures. Other treatments that all children receive in the community will be recorded with bi-monthly surveys.
- Spontaneous communicative utterances [ Time Frame: 12 weeks ]measured from a naturalistic language sample
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291172
|United States, Tennessee|
|Metro Nashville Schools|
|Nashville, Tennessee, United States, 37209|