Improving Services and Outcomes for Children With Autism Spectrum Disorder (ASD)

Autism Spectrum Disorders Clinical Trial

Official title:

Improving Part C Services and Outcomes for Under-resourced Children With ASD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800539
• Other study ID #: NA_00023642
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: June 2022

Study information

• Verified date: July 2022
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based on the need to characterize and improve early intervention services for minority and under-resourced children with ASD, this study translates a manualized and proven training model to examine its impact on the use of evidence-based practices (EBP) by early intervention providers, and to examine its relationship to child and family outcomes. By highlighting the impact of EBP-focused training on participating providers, children, and families, findings of the proposed study have the potential to effect significant change in the organization and delivery of early intervention services for minority and under-resourced children with ASD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 42 Months

Eligibility

Inclusion Criteria for Providers:

• Providers must be employed by an Infants and Toddlers Program; and
• Serve at least one eligible child with ASD

Inclusion Criteria for Families/Children:

• Children must be between 12 months, 0 days and 35 months, 30 days of age at entry into the study;
• Children must meet criteria on the Autism Diagnostic Observation Schedule (ADOS) for ASD or autism; and
• Caregiver and child must be available for all assessments

Exclusion Criteria for Families/Children:

• Children will be excluded if they are in foster care or wards of the state
• Caregiver must be fluent in speaking and understanding the English language

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder

Intervention

Behavioral:
• Provider Education Model (PEM)
Providers will be trained to use evidence-based practices for early intervention service delivery in the Autism Spectrum Disorder population.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Provider Delivery Service Practices	Provider measure	Baseline and 6 months into treatment
Secondary	Change in Baseline Mullen Scales of Early Learning	Child measure	Baseline and 6 months into treatment
Secondary	Change in Baseline Autism Diagnostic Observation Schedule	Child measure	Baseline and 6 months into treatment
Secondary	Change in Caregiver Interaction with Child	Caregiver measure	Baseline and 6 months into treatment