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Clinical Trials/NCT01529580
NCT01529580
Completed
N/A

School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.1 site in 1 country13 target enrollmentJanuary 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Enrollment
13
Locations
1
Primary Endpoint
Change in Baseline Spontaneous Language
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This project will address a major challenge to the field of autism research: improving expressive communication in children with autism who have reached school age but have not acquired functional spoken language (non-verbal school aged children with autism; NVSACA).

Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger site and follow-up testing but continue to have minimal functional spoken language will be participants in this study. After eligibility is established, participants will be randomly assigned to a baseline duration of one week, two weeks or three weeks before the start of active treatment. Once the baseline duration is completed, participants begin active treatment one hour of intervention three days per week in the participants' school setting. In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to improve the child's generalization of skills and teach parents the strategies implemented in their child's treatment. Post-baseline and post-treatment assessments will be completed in the lab at a time that is convenient for the participants' families.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
December 2013
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rebecca Landa

Director of the Center for Autism and Related Disorders (CARD) and Professor, Johns Hopkins University School of Medicine

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of autism by a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by the Autism Diagnostic Observation Schedule (ADOS; Lord, Rutter, DiLavore, \& Risi, 1999)
  • Chronological age between 4.0 years and 7 years, 11 months
  • Reynell developmental score ≤ 24 months, ADOS A1 score of 2, 3 or 8
  • Nonverbal IQ of ≥ 40 (Leiter International Performance Scale-Revised (Leiter-R), Roid \& Miller, 2007)
  • Children have participated in and completed follow-up testing for the ICAN study.

Exclusion Criteria

  • Major medical conditions other than autism (e.g., genetic disorders \[e.g., Fragile X, Down syndrome, tuberous sclerosis\], blindness or deafness, and motor disabilities such as cerebral palsy;
  • Uncontrolled seizures;
  • Self-injurious behavior or moderate to severe aggression.
  • Children in foster care.
  • Children who are exposed to \< 50% English throughout their typical day.
  • Children currently participating in another intervention/treatment study.

Outcomes

Primary Outcomes

Change in Baseline Spontaneous Language

Time Frame: Weekly throughout the 5 month intervention (baseline and 5 months)

The number of unprompted spontaneous language during a 15min play sample.

Secondary Outcomes

  • Change in Baseline Reynell(5 months into treatment (at completion of intervention))
  • Changes in Baseline Early Social Communication Scales (ESCS)(5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention)
  • Changes in Baseline Structured Play Assessment(5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention)
  • Change in Baseline Autism Diagnostic Observation Schedule(5 months into treatment (at completion of intervention))

Study Sites (1)

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