Clinical trial NCT01529580: School-Age Children With Autism With Limited Expressive Language Skills
Official title: School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
language
intervention
school-age
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-02-09
Enrollment: 13
Sex: ALL
Minimum age (years): 48
Maximum age (years): 95
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Baseline Spontaneous Language
timeFrame: Weekly throughout the 5 month intervention (baseline and 5 months)
Secondary outcomes:
measure: Change in Baseline Autism Diagnostic Observation Schedule
timeFrame: 5 months into treatment (at completion of intervention)
measure: Change in Baseline Reynell
timeFrame: 5 months into treatment (at completion of intervention)
measure: Changes in Baseline Early Social Communication Scales (ESCS)
timeFrame: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
measure: Changes in Baseline Structured Play Assessment
timeFrame: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Rebecca Landa, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: