School-Age Children With Autism With Limited Expressive Language Skills

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT01529580
• Lead Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Baseline Spontaneous Language	Weekly throughout the 5 month intervention (baseline and 5 months)	The number of unprompted spontaneous language during a 15min play sample.

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States