School-Age Children With Autism With Limited Expressive Language Skills

NCT ID: NCT01529580

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-12-31

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 48 Months
• Maximum Eligible Age: 95 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Landa

Director of the Center for Autism and Related Disorders (CARD) and Professor, Johns Hopkins University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Landa, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Kennedy Krieger Institute

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

3R01MH085048-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00049467

Identifier Type: -

Identifier Source: org_study_id