NCT02291172

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

3.3 years

First QC Date

November 6, 2014

Last Update Submit

July 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Spontaneous communicative utterances

    measured from a naturalistic language sample

    12 weeks

Study Arms (2)

Intervention JEP

EXPERIMENTAL

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

Business as Usual Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention JEP

Eligibility Criteria

Age36 Months - 54 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Sensory disabilities such as blindness or deafness
  • Motor disabilities such as cerebral palsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metro Nashville Schools

Nashville, Tennessee, 37209, United States

Location

Related Publications (1)

  • Hampton LH, Kaiser AP, Fuller EA. Multi-component communication intervention for children with autism: A randomized controlled trial. Autism. 2020 Nov;24(8):2104-2116. doi: 10.1177/1362361320934558. Epub 2020 Jul 6.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Susan W. Gray Professor of Education and Human Development, Dept. of Special Education

Study Record Dates

First Submitted

November 6, 2014

First Posted

November 14, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

July 12, 2018

Record last verified: 2018-07

Locations