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School-Age Children With Autism With Limited Expressive Language Skills

Primary Purpose

Autism Spectrum Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, language, intervention, school-age

Eligibility Criteria

48 Months - 95 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

1 Week Basline Prior to Intervention

2 Week Basline Prior to Intervention

3 Week Basline Prior to Intervention

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Baseline Spontaneous Language

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

Secondary Outcome Measures

Change in Baseline Autism Diagnostic Observation Schedule

Change in Baseline Reynell

Changes in Baseline Early Social Communication Scales (ESCS)

Changes in Baseline Structured Play Assessment

Full Information

NCT ID

NCT01529580

First Posted

February 6, 2012

Last Updated

March 9, 2021

Sponsor

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

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01529580

Brief Title

School-Age Children With Autism With Limited Expressive Language Skills

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder, language, intervention, school-age

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 Week Basline Prior to Intervention

Arm Type

Experimental

Arm Description

Arm Title

2 Week Basline Prior to Intervention

Arm Type

Experimental

Arm Description

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.

Arm Title

3 Week Basline Prior to Intervention

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

Change in Baseline Spontaneous Language

Description

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

Time Frame

Weekly throughout the 5 month intervention (baseline and 5 months)

Secondary Outcome Measure Information:

Title

Change in Baseline Autism Diagnostic Observation Schedule

Time Frame

5 months into treatment (at completion of intervention)

Title

Change in Baseline Reynell

Time Frame

5 months into treatment (at completion of intervention)

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

48 Months

Maximum Age & Unit of Time

95 Months

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca Landa, PhD, CCC-SLP

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kennedy Krieger Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21211

Country

United States

12. IPD Sharing Statement

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School-Age Children With Autism With Limited Expressive Language Skills

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