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Completed

NCT Number: NCT01529580

School-Age Children With Autism With Limited Expressive Language Skills

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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communication Language Mental Disorders Neurodevelopmental Disorders

Age range

48 month–95 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Change in Baseline Spontaneous Language

    Time frame: Weekly throughout the 5 month intervention (baseline and 5 months)

    The number of unprompted spontaneous language during a 15min play sample.

Secondary outcomes

  1. Change in Baseline Autism Diagnostic Observation Schedule

    Time frame: 5 months into treatment (at completion of intervention)

  2. Change in Baseline Reynell

    Time frame: 5 months into treatment (at completion of intervention)

  3. Changes in Baseline Early Social Communication Scales (ESCS)

    Time frame: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention

  4. Changes in Baseline Structured Play Assessment

    Time frame: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 9, 2012
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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