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Completed

NCT Number: NCT01800539

Improving Services and Outcomes for Children With Autism Spectrum Disorder (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.

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Key information

Conditions

Autism Spectrum Disorders Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

12 month–42 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Provider Education Model (PEM)

Behavioral

Providers will be trained to use evidence-based practices for early intervention service delivery in the Autism Spectrum Disorder population.

Primary outcomes

  1. Change in Provider Delivery Service Practices

    Time frame: Baseline and 6 months into treatment

    Provider measure

Secondary outcomes

  1. Change in Baseline Mullen Scales of Early Learning

    Time frame: Baseline and 6 months into treatment

    Child measure

  2. Change in Baseline Autism Diagnostic Observation Schedule

    Time frame: Baseline and 6 months into treatment

    Child measure

  3. Change in Caregiver Interaction with Child

    Time frame: Baseline and 6 months into treatment

    Caregiver measure

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2013
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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