School-Age Children With Autism With Limited Expressive Language Skills

NCT01529580 | Completed

• 2 other identifiers: NA_000494673R01MH085048-03S1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; language; intervention; school-age

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Baseline Autism Diagnostic Observation Schedule

  5 months into treatment (at completion of intervention)

• 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

Study Arms (3)

1 Week Basline Prior to Intervention

EXPERIMENTAL

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.

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

2 Week Basline Prior to Intervention

EXPERIMENTAL

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.

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

3 Week Basline Prior to Intervention

EXPERIMENTAL

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.

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

Interventions

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

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.

1 Week Basline Prior to Intervention; 2 Week Basline Prior to Intervention; 3 Week Basline Prior to Intervention

Eligibility Criteria

• Age: 48 Months - 95 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Language

Interventions

Methods

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Rebecca Landa, PhD, CCC-SLP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Autism and Related Disorders (CARD) and Professor, Johns Hopkins University School of Medicine

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 9, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

US (1)