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

NCT01800539 | Completed

• 1 other identifier: NA_00023642
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorders

Keywords

Autism; Early Intervention; Minority

Outcome Measures

Primary Outcomes (1)

• Change in Provider Delivery Service Practices

  Provider measure

  Baseline and 6 months into treatment

Secondary Outcomes (3)

• Change in Baseline Mullen Scales of Early Learning

  Baseline and 6 months into treatment

• Change in Baseline Autism Diagnostic Observation Schedule

  Baseline and 6 months into treatment

• Change in Caregiver Interaction with Child

  Baseline and 6 months into treatment

Study Arms (2)

Provider Education Model (PEM)

EXPERIMENTAL

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

Behavioral: Provider Education Model (PEM)

Treatment-as-Usual (TAU)

NO INTERVENTION

condition wherein providers continue with their existing practices

Interventions

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.

Provider Education Model (PEM)

Eligibility Criteria

• Age: 12 Months - 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Rebecca Landa, PhD, CCC-SLP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 27, 2013
• Study Start: February 1, 2014
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

US (1)