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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01MH085048-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Week Basline Prior to Intervention | Experimental | 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. |
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| 2 Week Basline Prior to Intervention | Experimental | 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. |
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| 3 Week Basline Prior to Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Verbal School Aged Children with Autism (NVSACA) Intervention | Behavioral | The intervention has 3 components:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline Spontaneous Language | The number of unprompted spontaneous language during a 15min play sample. | Weekly throughout the 5 month intervention (baseline and 5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline Autism Diagnostic Observation Schedule | 5 months into treatment (at completion of intervention) | |
| Change in Baseline Reynell | 5 months into treatment (at completion of intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Landa, PhD, CCC-SLP | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kennedy Krieger Institute | Baltimore | Maryland | 21211 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D007802 | Language |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003142 | Communication |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Changes in Baseline Early Social Communication Scales (ESCS) | 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention |
| Changes in Baseline Structured Play Assessment | 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention |
| D001519 | Behavior |