School-Age Children With Autism With Limited Expressive Language Skills
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01529580 |
Recruitment Status
:
Completed
First Posted
: February 9, 2012
Last Update Posted
: November 22, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Autism Spectrum Disorder | Behavioral: Non-Verbal School Aged Children with Autism (NVSACA) Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 Week Basline Prior to Intervention
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
The intervention has 3 components:
|
Experimental: 2 Week Basline Prior to Intervention
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
The intervention has 3 components:
|
Experimental: 3 Week Basline Prior to Intervention
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
The intervention has 3 components:
|
- 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.
- Change in Baseline Autism Diagnostic Observation Schedule [ Time Frame: 5 months into treatment (at completion of intervention) ]
- Change in Baseline Reynell [ Time Frame: 5 months into treatment (at completion of intervention) ]
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 48 Months to 95 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529580
United States, Maryland | |
Kennedy Krieger Institute | |
Baltimore, Maryland, United States, 21211 |
Principal Investigator: | Rebecca Landa, PhD, CCC-SLP | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
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 ( U.S. NIH Grant/Contract ) |
First Posted: | February 9, 2012 Key Record Dates |
Last Update Posted: | November 22, 2017 |
Last Verified: | November 2017 |
Keywords provided by Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
Autism Spectrum Disorder language intervention school-age |
Additional relevant MeSH terms:
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |