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School-Age Children With Autism With Limited Expressive Language Skills

This study is currently recruiting participants.
Verified January 2013 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01529580
First received: February 6, 2012
Last updated: January 4, 2013
Last verified: January 2013
History of Changes

February 6, 2012
January 4, 2013
January 2012
May 2013   (final data collection date for primary outcome measure)
Change in Baseline Spontaneous Language [ Time Frame: Weekly throughout the 5 month intervention (baseline and 5 months) ] [ Designated as safety issue: No ]
The number of unprompted spontaneous language during a 15min play sample.
Same as current
Complete list of historical versions of study NCT01529580 on ClinicalTrials.gov Archive Site
  • Change in Baseline Autism Diagnostic Observation Schedule [ Time Frame: 5 months into treatment (at completion of intervention) ] [ Designated as safety issue: No ]
  • Change in Baseline Reynell [ Time Frame: 5 months into treatment (at completion of intervention) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
School-Age Children With Autism With Limited Expressive Language Skills
School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study

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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Autism Spectrum Disorder
Behavioral: Non-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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
May 2013
May 2013   (final data collection date for primary outcome measure)

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 ≤ 18 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.
Both
48 Months to 95 Months
No
Contact: Rebecca Landa, PhD, CCC-SLP 443-923-7551 landa@kennedykrieger.org
Contact: Pamela Mathy, PhD, CCC-SLP 443-923-7627 Mathy@kennedykrieger.org
United States
 
NCT01529580
NA_00049467, 3R01MH085048-03S1
No
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
National Institute of Mental Health (NIMH)
Principal Investigator: Rebecca Landa, PhD, CCC-SLP Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP