Autism Spectrum DisordersNCT01800539
Improving Services and Outcomes for Children With Autism Spectrum Disorder (ASD)
A study testing Provider Education Model (PEM) in people with Autism Spectrum Disorders, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Provider Education Model (PEM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jun 2022
- 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 12 to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21211
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Provider Education Model (PEM)
- Keywords
- Autism, Early Intervention, Minority
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider Education Model (PEM)Behavioural
Providers will be trained to use evidence-based practices for early intervention service delivery in the Autism Spectrum Disorder population.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Provider Education Model (PEM) |
| Treatment-as-Usual (TAU) | No intervention | condition wherein providers continue with their existing practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Provider Delivery Service Practices
Provider measure
Measured: Baseline and 6 months into treatment
Secondary outcomes (3)
Change in Baseline Mullen Scales of Early Learning
Child measure
Measured: Baseline and 6 months into treatment
Change in Baseline Autism Diagnostic Observation Schedule
Child measure
Measured: Baseline and 6 months into treatment
Change in Caregiver Interaction with Child
Caregiver measure
Measured: Baseline and 6 months into treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2022
- Study completionJun 2022
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Rebecca Landa, PhD, CCC-SLP, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800539
- Sponsor's protocol ID
- NA_00023642
- Status last verified
- Jul 2022
- First submitted
- 4 Feb 2013
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Part C Services and Outcomes for Under-resourced Children With ASD
- ClinicalTrials.gov ID
- NCT01800539
- Acronym / sponsor ID
- NA_00023642
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism, Early Intervention, Minority
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- Feb 2014
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 27 Feb 2013 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider Education Model (PEM) | Experimental | Behavioral: Provider Education Model (PEM)condition wherein providers will receive specially structured training during their typical home visits based by Kennedy Krieger Institute (KKI) staff |
| Treatment-as-Usual (TAU) | No intervention | –condition wherein providers continue with their existing practices |
Who may qualify
- Ages
- 12 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Provider Education Model (PEM)Providers will be trained to use evidence-based practices for early intervention service delivery in the Autism Spectrum Disorder population. | Behavioural | Provider Education Model (PEM) |
Primary outcome
Change in Provider Delivery Service Practices
Time frame: Baseline and 6 months into treatment
Provider measure
3 secondary outcomes
Change in Baseline Mullen Scales of Early Learning
Time frame: Baseline and 6 months into treatment
Change in Baseline Autism Diagnostic Observation Schedule
Time frame: Baseline and 6 months into treatment
Change in Caregiver Interaction with Child
Time frame: Baseline and 6 months into treatment
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 8 Jul 2022.
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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.
Rebecca Landa, PhD, CCC-SLP principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Education Model (PEM) in people with Autism Spectrum Disorders, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site 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 5 inclusion and 2 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 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in Provider Delivery Service Practices (time frame: Baseline and 6 months into treatment). 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 8 Jul 2022.