School-Age Children With Autism With Limited Expressive Language Skills - Full Text View

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:	Allocation: Randomized 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:

MedlinePlus related topics: Autism Spectrum Disorder

U.S. FDA Resources

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 ]


Enrollment:	13
Study Start Date:	January 2012
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: 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.
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: 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.
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: 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.

Eligibility


Ages Eligible for Study:	48 Months to 95 Months (Child)
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 ≤ 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.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529580

Locations


United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211

Sponsors and Collaborators

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

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Rebecca Landa, PhD, CCC-SLP	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

More Information


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:	April 14, 2016
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 Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016