Autism Spectrum DisordersESI-CONCT01250938
Effectiveness of Early Intervention in an Underserved Population
A study testing ESI - Community Outreach in people with Autism Spectrum Disorders, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
The purpose of this study is to test the applicability of a caregiver-implemented autism intervention protocol to a deliberately recruited low-income, underserved population. Read more about this study
- Who is it for?
- Ages 24 to 54 months
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- ESI - Community Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 54 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- caregiver(s) with less than a 4-year college degree
- family income equal to or below 2x the federal poverty line
- English as the predominantly-spoken language.
- child received diagnosis of autism spectrum disorder before treatment
- child is between 24 and 42 months at the start of treatment
- child has normal hearing and adequate motor control to make simple actions (giving, reaching)
- family agrees to 2-4 weeks of weekly 1-hour observations, 3 months of 2 intervention sessions per week, and 3 months of 1 intervention session per month.
- family agrees to pre-treatment, post-treatment, and follow-up evaluation and videotaping of intervention sessions and weekly video check during the treatment.
Who cannot join
- -Must meet eligibility requirements stated above.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida State University
Tallahassee, Florida, 32301
Weill Cornell Medical College
White Plains, New York, 10605
About this study
Official title: 2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum
The purpose of this study is to test the applicability of a caregiver-implemented autism intervention protocol to a deliberately recruited low-income, underserved population.
Read the detailed description
Families of racial/ethnic minority, lower levels of education, and those who live in non-metropolitan areas have been found to experience greater limitations in accessing services for Autism Spectrum Disorder (ASD) (Thomas, Ellis, McLaurin, Daniels, \& Morrissey, 2007). Black and Hispanic children have been found to have lower odds of having a documented ASD classification than white children (Mandell, Wiggins, Arnstein Carpenter, Daniels, Durkin et al., 2009) and of those children who do receive an ASD diagnosis, many of them are not diagnosed in early childhood. The age of first ASD diagnosis received has been found to be significantly higher for African American and Latino children compared to white children (Mandell, Listerud, Levy, \& Pinto-Martin, 2002). For these reasons, it is important that the effectiveness of intensive early intervention for children with ASD is examined across varying cultural and socioeconomic backgrounds.
This project is directed by Dr. Catherine Lord at the University of Michigan, in collaboration with Dr. Amy Wetherby at Florida State University to test the applicability of a modified caregiver-implemented autism intervention (Modified Early Social Interaction; ESI) to a deliberately recruited low-income, underserved population. UM will recruit 28 children and FSU will recruit 16 children diagnosed with ASD who are between 24 and 42 months of age over a period of 3 years, totaling 44 caregiver-child dyads. This study will utilize a multiple baseline single-subject research design. Dyads will complete 1 month of weekly 1-hour baseline observations followed by three months of the modified ESI intervention. Child and family characteristics predicting response to intervention will be identified and findings will contribute to the development of autism interventions serving families from diverse backgrounds.
- Conditions
- Autism Spectrum Disorders
- Being tested
- ESI - Community Outreach
- Keywords
- autism, autism spectrum disorders, pervasive developmental disorders, intervention, low-income, underserved populations, underrepresented populations
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESI - Community OutreachBehavioural
Also called Modified ESI
This is an individualized caregiver-implemented intervention (ESI-CO) offered in 2 weekly sessions to teach caregivers how to embed strategies to support social communication skills within everyday routines, activities, and places for 3 months. Additionally, families receive 6 months (3 months during weekly home sessions and three months upon the completion of weekly home sessions) of resource support to identify local and community autism programs available for continued intervention and services.
| Study group | Role | What they receive |
|---|---|---|
| ESI - Community Outreach | Experimental | All families receive the same Early Social Intervention - Community Outreach (ESI-CO) treatment for 3 months in addition to 6 months of community resource support. Receives: Behavioral: ESI - Community Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Transactional Support
Measures caregiver's development of behavioral strategies to support child's social and communicative behavior.
Measured: Weekly
Secondary outcomes (2)
Child Outcome
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior.
Measured: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly
Caregiver Outcome
Caregiver measures self-reported family functioning, resources, well-being and treatment adherence, fidelity, and satisfaction
Measured: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJul 2009
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Autism Speaks, Florida State University
- Responsible party
- Principal investigator, Catherine Lord, Ph.D., University of California, Los Angeles
- Investigators
- Catherine Lord, Ph.D., Principal investigator, Weill Medical College of Cornell UniversityAmy Wetherby, Ph.D., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250938
- Sponsor's protocol ID
- 1108011843
- Other IDs
- Autism Speaks 5766, R01MH078165
- Acronym
- ESI-CO
- Status last verified
- May 2023
- First submitted
- 30 Nov 2010
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data are maintained by Florida Statue University, the data coordinating center for this collaborative project. We have shared deidentified study data by depositing it in the NIH National Database for Autism Research (NDAR). We have a long-standing commitment to making our data available to other investigators. As part of our previous work with NIMH (e.g. NIMH Collaborative RO1 MH089390) and others (e.g. Simons Simplex Collection), our data collection methods and data structures have been designed with NDAR's data-sharing protocol in mind (we collect information necessary to generate the Global Unique Identifier). Our study uses standardized assessments and all data are maintained in a secure database.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum
- ClinicalTrials.gov ID
- NCT01250938
- Acronym / sponsor ID
- ESI-CO / 1108011843
- Conditions
- Autism Spectrum Disorders
- Keywords
- autism, autism spectrum disorders, pervasive developmental disorders, intervention, low-income, underserved populations, underrepresented populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Autism Speaks, Florida State University
- Study start
- Jul 2009
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the applicability of a caregiver-implemented autism intervention protocol to a deliberately recruited low-income, underserved population.
Detailed description
Families of racial/ethnic minority, lower levels of education, and those who live in non-metropolitan areas have been found to experience greater limitations in accessing services for Autism Spectrum Disorder (ASD) (Thomas, Ellis, McLaurin, Daniels, \& Morrissey, 2007). Black and Hispanic children have been found to have lower odds of having a documented ASD classification than white children (Mandell, Wiggins, Arnstein Carpenter, Daniels, Durkin et al., 2009) and of those children who do receive an ASD diagnosis, many of them are not diagnosed in early childhood. The age of first ASD diagnosis received has been found to be significantly higher for African American and Latino children compared to white children (Mandell, Listerud, Levy, \& Pinto-Martin, 2002). For these reasons, it is important that the effectiveness of intensive early intervention for children with ASD is examined across varying cultural and socioeconomic backgrounds.
This project is directed by Dr. Catherine Lord at the University of Michigan, in collaboration with Dr. Amy Wetherby at Florida State University to test the applicability of a modified caregiver-implemented autism intervention (Modified Early Social Interaction; ESI) to a deliberately recruited low-income, underserved population. UM will recruit 28 children and FSU will recruit 16 children diagnosed with ASD who are between 24 and 42 months of age over a period of 3 years, totaling 44 caregiver-child dyads. This study will utilize a multiple baseline single-subject research design. Dyads will complete 1 month of weekly 1-hour baseline observations followed by three months of the modified ESI intervention. Child and family characteristics predicting response to intervention will be identified and findings will contribute to the development of autism interventions serving families from diverse backgrounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESI - Community Outreach | Experimental | Behavioral: ESI - Community OutreachAll families receive the same Early Social Intervention - Community Outreach (ESI-CO) treatment for 3 months in addition to 6 months of community resource support. |
Who may qualify
- Ages
- 24 to 54 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- caregiver(s) with less than a 4-year college degree
- family income equal to or below 2x the federal poverty line
- English as the predominantly-spoken language.
- child received diagnosis of autism spectrum disorder before treatment
- child is between 24 and 42 months at the start of treatment
Key exclusion criteria (1 listed)
- -Must meet eligibility requirements stated above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESI - Community OutreachAlso: Modified ESIThis is an individualized caregiver-implemented intervention (ESI-CO) offered in 2 weekly sessions to teach caregivers how to embed strategies to support social communication skills within everyday routines, activities, and places for 3 months. Additionally, families receive 6 months (3 months during weekly home sessions and three months upon the completion of weekly home sessions) of resource support to identify local and community autism programs available for continued intervention and services. | Behavioural | ESI - Community Outreach |
Primary outcome
Caregiver Transactional Support
Time frame: Weekly
Measures caregiver's development of behavioral strategies to support child's social and communicative behavior.
2 secondary outcomes
Child Outcome
Time frame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly
Caregiver Outcome
Time frame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Yes. Data are maintained by Florida Statue University, the data coordinating center for this collaborative project. We have shared deidentified study data by depositing it in the NIH National Database for Autism Research (NDAR). We have a long-standing commitment to making our data available to other investigators. As part of our previous work with NIMH (e.g. NIMH Collaborative RO1 MH089390) and others (e.g. Simons Simplex Collection), our data collection methods and data structures have been designed with NDAR's data-sharing protocol in mind (we collect information necessary to generate the Global Unique Identifier). Our study uses standardized assessments and all data are maintained in a secure database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Lord, Ph.D. principal investigator
Weill Medical College of Cornell University
Amy Wetherby, Ph.D. principal investigator
Florida State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESI - Community Outreach in people with Autism Spectrum Disorders, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Transactional Support (time frame: Weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.