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School-Age Children With Autism With Limited Expressive Language Skills

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01529580
Enrollment
13
Registered
2012-02-09
Start date
2012-01-31
Completion date
2013-12-31
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder, language, intervention, school-age

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.

Interventions

BEHAVIORALNon-Verbal School Aged Children with Autism (NVSACA) Intervention

The intervention has 3 components: 1. 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. 2. 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. 3. 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
48 Months to 95 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Baseline Spontaneous LanguageWeekly throughout the 5 month intervention (baseline and 5 months)The number of unprompted spontaneous language during a 15min play sample.

Secondary

MeasureTime frame
Change in Baseline Autism Diagnostic Observation Schedule5 months into treatment (at completion of intervention)
Change in Baseline Reynell5 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 Assessment5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026