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

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provider Education Model (PEM)
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring Autism, Early Intervention, Minority

Eligibility Criteria

12 Months - 42 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Provider Education Model (PEM)

Treatment-as-Usual (TAU)

Arm Description

condition wherein providers will receive specially structured training during their typical home visits based by Kennedy Krieger Institute (KKI) staff

condition wherein providers continue with their existing practices

Outcomes

Primary Outcome Measures

Change in Provider Delivery Service Practices
Provider measure

Secondary Outcome Measures

Change in Baseline Mullen Scales of Early Learning
Child measure
Change in Baseline Autism Diagnostic Observation Schedule
Child measure
Change in Caregiver Interaction with Child
Caregiver measure

Full Information

First Posted
February 4, 2013
Last Updated
July 6, 2022
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Health Resources and Services Administration (HRSA)
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1. Study Identification

Unique Protocol Identification Number
NCT01800539
Brief Title
Improving Services and Outcomes for Children With Autism Spectrum Disorder (ASD)
Official Title
Improving Part C Services and Outcomes for Under-resourced Children With ASD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
June 2022 (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
Health Resources and Services Administration (HRSA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
Autism, Early Intervention, Minority

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provider Education Model (PEM)
Arm Type
Experimental
Arm Description
condition wherein providers will receive specially structured training during their typical home visits based by Kennedy Krieger Institute (KKI) staff
Arm Title
Treatment-as-Usual (TAU)
Arm Type
No Intervention
Arm Description
condition wherein providers continue with their existing practices
Intervention Type
Behavioral
Intervention Name(s)
Provider Education Model (PEM)
Intervention Description
Providers will be trained to use evidence-based practices for early intervention service delivery in the Autism Spectrum Disorder population.
Primary Outcome Measure Information:
Title
Change in Provider Delivery Service Practices
Description
Provider measure
Time Frame
Baseline and 6 months into treatment
Secondary Outcome Measure Information:
Title
Change in Baseline Mullen Scales of Early Learning
Description
Child measure
Time Frame
Baseline and 6 months into treatment
Title
Change in Baseline Autism Diagnostic Observation Schedule
Description
Child measure
Time Frame
Baseline and 6 months into treatment
Title
Change in Caregiver Interaction with Child
Description
Caregiver measure
Time Frame
Baseline and 6 months into treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
42 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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

Learn more about this trial

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

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