School-Age Children With Autism With Limited Expressive Language Skills

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529580
• Other study ID #: NA_00049467
• Secondary ID: 3R01MH085048-03S
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2021
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Months to 95 Months

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Non-Verbal School Aged Children with Autism (NVSACA) Intervention
The intervention has 3 components: One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention. Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention. Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline Spontaneous Language	The number of unprompted spontaneous language during a 15min play sample.	Weekly throughout the 5 month intervention (baseline and 5 months)
Secondary	Change in Baseline Autism Diagnostic Observation Schedule		5 months into treatment (at completion of intervention)
Secondary	Change in Baseline Reynell		5 months into treatment (at completion of intervention)
Secondary	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
Secondary	Changes in Baseline Structured Play Assessment		5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention