Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Provider Education Model (PEM)

Behavioral
Who is being recruted

Mental Disorders+2

+ Child Development Disorders, Pervasive

+ Neurodevelopmental Disorders

From 12 to 42 Months
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2014
See protocol details

Summary

Principal SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
Last updated: July 8, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2014

Actual date on which the first participant was enrolled.

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.

Principal SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
Last updated: July 8, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

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

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 42 Months

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersChild Development Disorders, PervasiveNeurodevelopmental DisordersAutism Spectrum DisorderAutistic Disorder

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

No Intervention
condition wherein providers continue with their existing practices

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Kennedy Krieger Institute

Baltimore, United StatesOpen Kennedy Krieger Institute in Google Maps
CompletedOne Study Center