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

July 6, 2022 updated by: Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21211
        • Kennedy Krieger Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Provider Education Model (PEM)
condition wherein providers will receive specially structured training during their typical home visits based by Kennedy Krieger Institute (KKI) staff
Providers will be trained to use evidence-based practices for early intervention service delivery in the Autism Spectrum Disorder population.
No Intervention: Treatment-as-Usual (TAU)
condition wherein providers continue with their existing practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Provider Delivery Service Practices
Time Frame: Baseline and 6 months into treatment
Provider measure
Baseline and 6 months into treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline Mullen Scales of Early Learning
Time Frame: Baseline and 6 months into treatment
Child measure
Baseline and 6 months into treatment
Change in Baseline Autism Diagnostic Observation Schedule
Time Frame: Baseline and 6 months into treatment
Child measure
Baseline and 6 months into treatment
Change in Caregiver Interaction with Child
Time Frame: Baseline and 6 months into treatment
Caregiver measure
Baseline and 6 months into treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism Spectrum Disorders

Clinical Trials on Provider Education Model (PEM)

3
Subscribe