School-Age Children With Autism With Limited Expressive Language Skills

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

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01529580

NA_00049467

3R01MH085048-03S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 48 to 95 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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13 participants in 3 patient groups

1 Week Basline Prior to Intervention

Experimental group

Description:

If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist. In this case, the duration is 1 week before your child begins active treatment with their interventionist.

Treatment:

Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention

2 Week Basline Prior to Intervention

Experimental group

Description:

If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist. In this case, the duration is 2 weeks before your child begins active treatment with their interventionist.

Treatment:

Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention

3 Week Basline Prior to Intervention

Experimental group

Description:

If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist. In this case, the duration is 3 weeks before your child begins active treatment with their interventionist.

Treatment:

Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention