NCT01013545

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

November 12, 2009

Last Update Submit

June 10, 2024

Conditions

Keywords

joint engagementaugmentative communication (AAC)enhanced milieu trainingautism spectrum disorderlanguage

Outcome Measures

Primary Outcomes (1)

  • Number of words used spontaneously during language sample

    Change in spontaneous language from beginning of treatment, to the mid-point.

    3 months

Secondary Outcomes (1)

  • Number of words used spontaneously during language sample

    6 months

Study Arms (2)

JAE-EMT

EXPERIMENTAL

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.

Behavioral: JAE Intervention

JAE-AAC

EXPERIMENTAL

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.

Behavioral: JAE Intervention

Interventions

The overall goal in each session will be for the caregiver-child dyad to be in a state of supported or coordinated joint engagement. In this state the child is aware of the other's activity, and may actively coordinate their attention between an object/toy and the caregiver. The interventionist will coach the caregiver and child while they engage in play routines established through collaboration between caregiver and interventionist.

JAE-AACJAE-EMT

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Related Publications (12)

  • Kasari C. Assessing change in early intervention programs for children with autism. J Autism Dev Disord. 2002 Oct;32(5):447-61. doi: 10.1023/a:1020546006971.

    PMID: 12463519BACKGROUND
  • Kasari C, Paparella T, Freeman S, Jahromi LB. Language outcome in autism: randomized comparison of joint attention and play interventions. J Consult Clin Psychol. 2008 Feb;76(1):125-37. doi: 10.1037/0022-006X.76.1.125.

    PMID: 18229990BACKGROUND
  • Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. doi: 10.1111/j.1469-7610.2005.01567.x.

    PMID: 16712638BACKGROUND
  • Millar DC, Light JC, Schlosser RW. The impact of augmentative and alternative communication intervention on the speech production of individuals with developmental disabilities: a research review. J Speech Lang Hear Res. 2006 Apr;49(2):248-64. doi: 10.1044/1092-4388(2006/021).

    PMID: 16671842BACKGROUND
  • Kaiser AP, Trent JA. Communication intervention for young children with disabilities: Naturalistic approaches to promoting development. In S Odom, R Horner, M Snell & J Blacher (Eds), Handbook of Developmental Disabilities. New York: Guilford Press, 2007.

    BACKGROUND
  • Kaiser AP, Hancock TB, Nietfeld, JP. The effects of parent-implemented enhanced milieu teaching on the social communication of children who have autism. Journal of Early Educaiton and Development [Special Issue] 4: 423-446, 2000.

    BACKGROUND
  • Landa R. Early communication development and intervention for children with autism. Ment Retard Dev Disabil Res Rev. 2007;13(1):16-25. doi: 10.1002/mrdd.20134.

    PMID: 17326115BACKGROUND
  • Hancock TB, Kaiser, AP. Enhanced Milieu Teaching. In R. McCauley & M. Fey (Eds.) Treatment of language disorders in children. Baltimore: Paul H. Brookes. 2006.

    BACKGROUND
  • Shire SY, Goods K, Shih W, Distefano C, Kaiser A, Wright C, Mathy P, Landa R, Kasari C. Parents' Adoption of Social Communication Intervention Strategies: Families Including Children with Autism Spectrum Disorder Who are Minimally Verbal. J Autism Dev Disord. 2015 Jun;45(6):1712-24. doi: 10.1007/s10803-014-2329-x.

  • Kasari C, Patterson S. Interventions addressing social impairment in autism. Curr Psychiatry Rep. 2012 Dec;14(6):713-25. doi: 10.1007/s11920-012-0317-4.

  • Almirall D, DiStefano C, Chang YC, Shire S, Kaiser A, Lu X, Nahum-Shani I, Landa R, Mathy P, Kasari C. Longitudinal Effects of Adaptive Interventions With a Speech-Generating Device in Minimally Verbal Children With ASD. J Clin Child Adolesc Psychol. 2016 Jul-Aug;45(4):442-56. doi: 10.1080/15374416.2016.1138407. Epub 2016 Mar 8.

  • Kasari C, Kaiser A, Goods K, Nietfeld J, Mathy P, Landa R, Murphy S, Almirall D. Communication interventions for minimally verbal children with autism: a sequential multiple assignment randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):635-46. doi: 10.1016/j.jaac.2014.01.019. Epub 2014 Mar 12.

MeSH Terms

Conditions

Autism Spectrum DisorderLanguage

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersCommunicationBehavior

Study Officials

  • Connie Kasari, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor, Ph.D.

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 13, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations