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:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborator:
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Autism Spectrum Disorder |
Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study |
Resource links provided by NLM:
Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 15 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention
- 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.
The intervention has 3 components:
Eligibility| Ages Eligible for Study: | 48 Months to 95 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 ≤ 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529580
Contacts
| Contact: Rebecca Landa, PhD, CCC-SLP | 443-923-7551 | landa@kennedykrieger.org |
| Contact: Pamela Mathy, PhD, CCC-SLP | 443-923-7627 | Mathy@kennedykrieger.org |
Locations
| United States, Maryland | |
| Kennedy Krieger Institute | Recruiting |
| Baltimore, Maryland, United States, 21211 | |
| Contact: Rebecca Landa, PhD, CCC-SLP 443-923-7551 landa@kennedykrieger.org | |
| Contact: Pamela Mathy, PhD, CCC-SLP 443-923-7627 Mathy@kennedykrieger.org | |
| Principal Investigator: Rebecca Landa, PhD, CCC-SLP | |
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Investigators
| Principal Investigator: | Rebecca Landa, PhD, CCC-SLP | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
More Information
No publications provided
| Responsible Party: | Rebecca Landa, Director of the Center for Autism and Related Disorders (CARD) and Professor, Johns Hopkins University School of Medicine, Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
| ClinicalTrials.gov Identifier: | NCT01529580 History of Changes |
| Other Study ID Numbers: | NA_00049467, 3R01MH085048-03S1 |
| Study First Received: | February 6, 2012 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
|
Autism Spectrum Disorder language intervention school-age |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013