- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01800539
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
Conditions
Intervention / Treatment
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00023642
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
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
Emory UniversityNational Institute of Mental Health (NIMH)Terminated
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Florida State University; Autism...CompletedAutism Spectrum DisordersUnited States
-
University Hospital, MontpellierCaisse Nationale de Solidarité pour l'AutonomieActive, not recruitingAutism Spectrum DisordersFrance
-
Institut National de la Santé Et de la Recherche...Completed
-
Linmarie SikichEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedAutism Spectrum DisordersUnited States
-
National Human Genome Research Institute (NHGRI)CompletedAutism Spectrum DisordersUnited States
-
University of California, San DiegoCompletedAutism Spectrum DisordersUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH)Completed
Clinical Trials on Provider Education Model (PEM)
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingPain, BackUnited States
-
The University of Texas Health Science Center,...Baylor College of Medicine; Cancer Prevention Research Institute of TexasCompletedHuman Papillomavirus (HPV)United States
-
University of UtahVA Salt Lake City Health Care SystemWithdrawn
-
University of HawaiiAgency for Healthcare Research and Quality (AHRQ)Not yet recruiting
-
US Department of Veterans AffairsCompleted
-
University of MichiganUniversity of California, Irvine; Fresenius Medical Care North America; National...Enrolling by invitationCardiovascular Diseases | End Stage Renal Disease | Hypotension | Kidney Failure | Patient SafetyUnited States
-
University of PittsburghCompletedChronic Kidney DiseaseUnited States
-
Children's Hospital Medical Center, CincinnatiChildren's National Research Institute; Uganda Heart InstituteActive, not recruitingRheumatic Heart DiseaseUganda
-
University of ChicagoNorthwestern University; Ann & Robert H Lurie Children's Hospital of Chicago; Howard Brown Health Center and other collaboratorsRecruiting