AutismNCT02359084
Project EARLY: Engagement, Assessment, Referral, & Linkage for Young Children
A study testing Family Navigation and Conventional Care Management in people with Autism and Developmental Delay Disorders, run by Boston University at 10 sites in United States.
Trial summary
Emerging evidence demonstrates that Autism Spectrum Disorder (ASD) can be reliably diagnosed by age two, and that early identification and intervention can improve outcomes. Low-income and minority children with ASD, however, are diagnosed later and experience greater delays in service provision than their white and… Read more about this study
- Who is it for?
- Ages 15 to 27 months
- Conditions the study is for
- Autism, Developmental Delay Disorders
- What is being tested?
- Family Navigation and Conventional Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 10 sitesUnited States
- Study dates
- Feb 2015to 25 Aug 2021
- 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 15 to 27 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 15 - 27 months at a participating clinic who fail the M-CHAT screen and/or primary care provider has concerns about autism
Who cannot join
- Previous diagnosis of Autism Spectrum Disorder
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Boston Medical Center
Boston, Massachusetts, 02118
Boston University School of Public Health
Boston, Massachusetts, 02118
South End Community Health Center
Boston, Massachusetts, 02118
Dorchester House Multi-Service Center
Boston, Massachusetts, 02122
Codman Square Health Center
Boston, Massachusetts, 02124
East Boston Neighborhood Health Center
Boston, Massachusetts, 02128
MGH Chelsea
Chelsea, Massachusetts, 02150
Lowell Community Health Center
Lowell, Massachusetts, 01854
Yale University School of Medicine
New Haven, Connecticut, 06510
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Early Identification and Service Linkage for Urban Children With Autism
Emerging evidence demonstrates that Autism Spectrum Disorder (ASD) can be reliably diagnosed by age two, and that early identification and intervention can improve outcomes. Low-income and minority children with ASD, however, are diagnosed later and experience greater delays in service provision than their white and more financially advantaged peers. Feasible, culturally appropriate interventions with broad scale-up potential are necessary to reduce this disparity. This project builds upon pilot studies of an adapted version of Patient Navigation, as means to reduce disparities in ASD diagnosis and service provision. Patient Navigation is a lay-delivered case management approach that focuses on overcoming logistical hurdles to care during a defined episode.
This project has 2 components, both of which take place in urban, integrated care networks that provide healthcare to low-income children. This registration is for the clinical trial component of the study. The project is a multisite, randomized comparative effectiveness trial of a systemic, lay-delivered adaptation of Patient Navigation, referred to as Family Navigation (FN), which begins with a failed autism screen and ends 100 days after an ASD diagnosis is made. The basic structure of both intervention arms is a collaborative care system. The conventional care management arm (CCM) is consistent with the type of care provided within a traditional - but high quality - medical home. The FN arm provides more intensive, individually tailored, care coordination and theory-based family support.
Read the detailed description
We will conduct a randomized, comparative effectiveness trial to test a systemic, lay-delivered FN protocol against conventional care management services. The study will take place in three integrated primary care networks and their affiliated Developmental and Behavioral Pediatrics (DBP) clinics at Boston Medical Center, Children's Hospital of Philadelphia, and Yale University Medical School. We will enroll children with confirmed risk for ASD in the randomized trial and will employ 1:1 randomization by child. The FN protocol will include individualized navigation to support completion of the diagnostic evaluation, referral to appropriate services, and linkage to and engagement in services. We will determine FN's effect on identifying children at risk for ASD, timing of diagnosis, and receipt of evidence-based ASD services.
The study seeks to accomplish the following aims:
- Implement a decision rule for referral for formal ASD evaluation;
- Ensure timely diagnosis and deployment of services.
If successful, our study will provide real world primary care practices with a replicable model of care that increases early identification and access to timely diagnostic and early intervention services for a vulnerable population of urban families.
Children will be followed for 12 months. Data regarding screening outcomes, diagnosis and service utilization will be abstracted from children's medical records. Measures of parental stress, self-management skills, caregiver burden, and satisfaction with services will be administered over 4 collection time points, linked to key intervention outcomes. We will assess the superiority of FN as compared to CCM as a means to: implement a decision rule for referral to ASD evaluation; shorten the time to diagnosis among children suspected to have ASD; shorten the time to deployment of ASD services among those diagnosed; and improve engagement with ASD services.
- Conditions
- Autism, Developmental Delay Disorders
- Being tested
- Family Navigation, Conventional Care Management
- Keywords
- Autism Spectrum Disorder (ASD), Family navigation
- Medical subject headings
- Autistic Disorder, Developmental Disabilities, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family NavigationBehavioural
Conventional Care ManagementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Family Navigation | Experimental | Families will work one-on-one with the navigator who provides off-site support - e.g. home visits or accompanying families to appointments. The goal of FN during the diagnostic evaluation period is to ensure timely completion of the evaluation. The focus of these interactions is to understand the structure and purpose of the evaluation, gather and complete required materials, and address logistic barriers related to the diagnostic visit. The navigator will continue to work with the family after the diagnostic evaluation to access recommended services and support the family's engagement in treatment. Receives: Behavioral: Family Navigation |
| Conventional Care Management | Active comparator | Families will be assigned to a care manager for the diagnostic evaluation and for 100 days thereafter. Consistent with a high quality medical home, the care manager will be responsible to ensure that the referral for the diagnostic evaluation has been made. She is also available for family-initiated support. The care manager will be responsible for ensuring that referrals are made and continue to provide family-initiated, clinic-based support to families for up to 100 days after the completion of diagnostic evaluation. Receives: Behavioral: Conventional Care Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic interval (Number of days defined as beginning the day of the positive confirmatory screen and ending the day when the family receives a determination (yes/no) of ASD diagnosis)
Number of days defined as beginning the day of the positive confirmatory screen and ending the day when the family receives a determination (yes/no) of ASD diagnosis
Measured: On average 90 -120 days, specific date is linked to the completion of the developmental assessment
Time to receipt of ASD services/recommended services
Number of days from date of diagnosis to receipt of recommended services
Measured: 1 year
Secondary outcomes (2)
Determination of ASD diagnosis (based on DSM V criteria made by a Board Certified DBP Pediatrician. Assessments are based on site protocols; all use standardized, validated measures appropriate for very young children.)
Determination of ASD diagnosis will be based on DSM V criteria made by a Board Certified DBP Pediatrician. Assessments are based on site protocols; all use standardized, validated measures appropriate for very young children.
Measured: 1 year
Satisfaction with Family Navigator (Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I))
Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) is a newly validated 9 item scale to assess satisfaction with the interpersonal relationship with the navigator.
Measured: 100 days after developmental assessment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion25 Aug 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Children's Hospital of Philadelphia, National Institute of Mental Health (NIMH), Developmental Behavioral Pediatrics Research Network
- Responsible party
- Sponsor
- Investigators
- Emily Feinberg, ScD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359084
- Sponsor's protocol ID
- H-33008
- Other IDs
- 1R01MH104355
- Status last verified
- Dec 2021
- First submitted
- 1 Feb 2015
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with the National Database for Autism Research biannually.
Publications
Stransky ML, Kuhn J, Feinberg E. Agreement Between Parental Reports of Part C Early Intervention Service Utilization and Part C Early Intervention Service Records. Child Youth Care Forum. 2024 Aug;53(4):825-847. doi: 10.1007/s10566-023-09773-6. Epub 2023 Nov 2.
PubMed 42368493Levinson J, Hickey E, Fuchu P, Chu A, Barnett M, Stadnick NA, Feinberg E, Broder-Fingert S. Recommendations for post-implementation adaptations to optimize family navigation in pediatric primary care: a qualitative study with parents and navigators. BMC Prim Care. 2023 Jun 16;24(1):123. doi: 10.1186/s12875-023-02072-y.
PubMed 37328810Eilenberg JS, Kizildag D, Blakey AO, Cardona ND, Oberoi A, Broder-Fingert S, Feinberg E, Long KA. Implications of Universal Autism Screening: Perspectives From Culturally Diverse Families With False-Positive Screens. Acad Pediatr. 2022 Mar;22(2):279-288. doi: 10.1016/j.acap.2021.12.025. Epub 2021 Dec 25.
PubMed 34963655Feinberg E, Augustyn M, Broder-Fingert S, Bennett A, Weitzman C, Kuhn J, Hickey E, Chu A, Levinson J, Sandler Eilenberg J, Silverstein M, Cabral HJ, Patts G, Diaz-Linhart Y, Fernandez-Pastrana I, Rosenberg J, Miller JS, Guevara JP, Fenick AM, Blum NJ. Effect of Family Navigation on Diagnostic Ascertainment Among Children at Risk for Autism: A Randomized Clinical Trial From DBPNet. JAMA Pediatr. 2021 Mar 1;175(3):243-250. doi: 10.1001/jamapediatrics.2020.5218.
PubMed 33427861Broder-Fingert S, Walls M, Augustyn M, Beidas R, Mandell D, Wiltsey-Stirman S, Silverstein M, Feinberg E. A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder. BMC Psychiatry. 2018 Mar 27;18(1):79. doi: 10.1186/s12888-018-1661-7.
PubMed 29587698
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification and Service Linkage for Urban Children With Autism
- ClinicalTrials.gov ID
- NCT02359084
- Acronym / sponsor ID
- H-33008
- Conditions
- Autism, Developmental Delay Disorders
- Keywords
- Autism Spectrum Disorder (ASD), Family navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Yale University, Children's Hospital of Philadelphia, National Institute of Mental Health (NIMH), Developmental Behavioral Pediatrics Research Network
- Study start
- Feb 2015 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 9 Feb 2015 (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.
Emerging evidence demonstrates that Autism Spectrum Disorder (ASD) can be reliably diagnosed by age two, and that early identification and intervention can improve outcomes. Low-income and minority children with ASD, however, are diagnosed later and experience greater delays in service provision than their white and more financially advantaged peers. Feasible, culturally appropriate interventions with broad scale-up potential are necessary to reduce this disparity. This project builds upon pilot studies of an adapted version of Patient Navigation, as means to reduce disparities in ASD diagnosis and service provision. Patient Navigation is a lay-delivered case management approach that focuses on overcoming logistical hurdles to care during a defined episode.
This project has 2 components, both of which take place in urban, integrated care networks that provide healthcare to low-income children. This registration is for the clinical trial component of the study. The project is a multisite, randomized comparative effectiveness trial of a systemic, lay-delivered adaptation of Patient Navigation, referred to as Family Navigation (FN), which begins with a failed autism screen and ends 100 days after an ASD diagnosis is made. The basic structure of both intervention arms is a collaborative care system. The conventional care management arm (CCM) is consistent with the type of care provided within a traditional - but high quality - medical home. The FN arm provides more intensive, individually tailored, care coordination and theory-based family support.
Detailed description
We will conduct a randomized, comparative effectiveness trial to test a systemic, lay-delivered FN protocol against conventional care management services. The study will take place in three integrated primary care networks and their affiliated Developmental and Behavioral Pediatrics (DBP) clinics at Boston Medical Center, Children's Hospital of Philadelphia, and Yale University Medical School. We will enroll children with confirmed risk for ASD in the randomized trial and will employ 1:1 randomization by child. The FN protocol will include individualized navigation to support completion of the diagnostic evaluation, referral to appropriate services, and linkage to and engagement in services. We will determine FN's effect on identifying children at risk for ASD, timing of diagnosis, and receipt of evidence-based ASD services.
The study seeks to accomplish the following aims:
- Implement a decision rule for referral for formal ASD evaluation;
- Ensure timely diagnosis and deployment of services.
If successful, our study will provide real world primary care practices with a replicable model of care that increases early identification and access to timely diagnostic and early intervention services for a vulnerable population of urban families.
Children will be followed for 12 months. Data regarding screening outcomes, diagnosis and service utilization will be abstracted from children's medical records. Measures of parental stress, self-management skills, caregiver burden, and satisfaction with services will be administered over 4 collection time points, linked to key intervention outcomes. We will assess the superiority of FN as compared to CCM as a means to: implement a decision rule for referral to ASD evaluation; shorten the time to diagnosis among children suspected to have ASD; shorten the time to deployment of ASD services among those diagnosed; and improve engagement with ASD services.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Navigation | Experimental | Behavioral: Family NavigationFamilies will work one-on-one with the navigator who provides off-site support - e.g. home visits or accompanying families to appointments. The goal of FN during the diagnostic evaluation period is to ensure timely completion of the evaluation. The focus of these interactions is to understand the structure and purpose of the evaluation, gather and complete required materials, and address logistic barriers related to the diagnostic visit. The navigator will continue to work with the family after the diagnostic evaluation to access recommended services and support the family's engagement in treatment. |
| Conventional Care Management | Active comparator | Behavioral: Conventional Care ManagementFamilies will be assigned to a care manager for the diagnostic evaluation and for 100 days thereafter. Consistent with a high quality medical home, the care manager will be responsible to ensure that the referral for the diagnostic evaluation has been made. She is also available for family-initiated support. The care manager will be responsible for ensuring that referrals are made and continue to provide family-initiated, clinic-based support to families for up to 100 days after the completion of diagnostic evaluation. |
Who may qualify
- Ages
- 15 to 27 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children ages 15 - 27 months at a participating clinic who fail the M-CHAT screen and/or primary care provider has concerns about autism
Key exclusion criteria (1 listed)
- Previous diagnosis of Autism Spectrum Disorder
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 |
|---|---|---|
| Family Navigation | Behavioural | Family Navigation |
| Conventional Care Management | Behavioural | Conventional Care Management |
Primary outcome
Diagnostic interval (Number of days defined as beginning the day of the positive confirmatory screen and ending the day when the family receives a determination (yes/no) of ASD diagnosis)
Time frame: On average 90 -120 days, specific date is linked to the completion of the developmental assessment
Number of days defined as beginning the day of the positive confirmatory screen and ending the day when the family receives a determination (yes/no) of ASD diagnosis
Time to receipt of ASD services/recommended services
Time frame: 1 year
Number of days from date of diagnosis to receipt of recommended services
2 secondary outcomes
Determination of ASD diagnosis (based on DSM V criteria made by a Board Certified DBP Pediatrician. Assessments are based on site protocols; all use standardized, validated measures appropriate for very young children.)
Time frame: 1 year
Satisfaction with Family Navigator (Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I))
Time frame: 100 days after developmental assessment completion
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 3 Jan 2022.
- Derived from this study: PubMed 42368493Stransky ML, Kuhn J, Feinberg E. Agreement Between Parental Reports of Part C Early Intervention Service Utilization and Part C Early Intervention Service Records. Child Youth Care Forum. 2024 Aug;53(4):825-847. doi: 10.1007/s10566-023-09773-6. Epub 2023 Nov 2.
- Derived from this study: PubMed 37328810Levinson J, Hickey E, Fuchu P, Chu A, Barnett M, Stadnick NA, Feinberg E, Broder-Fingert S. Recommendations for post-implementation adaptations to optimize family navigation in pediatric primary care: a qualitative study with parents and navigators. BMC Prim Care. 2023 Jun 16;24(1):123. doi: 10.1186/s12875-023-02072-y.
- Derived from this study: PubMed 34963655Eilenberg JS, Kizildag D, Blakey AO, Cardona ND, Oberoi A, Broder-Fingert S, Feinberg E, Long KA. Implications of Universal Autism Screening: Perspectives From Culturally Diverse Families With False-Positive Screens. Acad Pediatr. 2022 Mar;22(2):279-288. doi: 10.1016/j.acap.2021.12.025. Epub 2021 Dec 25.
- Derived from this study: PubMed 33427861Feinberg E, Augustyn M, Broder-Fingert S, Bennett A, Weitzman C, Kuhn J, Hickey E, Chu A, Levinson J, Sandler Eilenberg J, Silverstein M, Cabral HJ, Patts G, Diaz-Linhart Y, Fernandez-Pastrana I, Rosenberg J, Miller JS, Guevara JP, Fenick AM, Blum NJ. Effect of Family Navigation on Diagnostic Ascertainment Among Children at Risk for Autism: A Randomized Clinical Trial From DBPNet. JAMA Pediatr. 2021 Mar 1;175(3):243-250. doi: 10.1001/jamapediatrics.2020.5218.
- Derived from this study: PubMed 29587698Broder-Fingert S, Walls M, Augustyn M, Beidas R, Mandell D, Wiltsey-Stirman S, Silverstein M, Feinberg E. A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder. BMC Psychiatry. 2018 Mar 27;18(1):79. doi: 10.1186/s12888-018-1661-7.
- Individual participant dataSharing planned: Yes. Data will be shared with the National Database for Autism Research biannually.
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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.
Emily Feinberg, ScD principal investigator
Boston University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Navigation and Conventional Care Management in people with Autism and Developmental Delay Disorders, run by Boston University at 10 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 1 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 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Diagnostic interval (Number of days defined as beginning the day of the positive confirmatory screen and ending the day when the family receives a determination (yes/no) of ASD diagnosis) (time frame: On average 90 -120 days, specific date is linked to the completion of the developmental assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359084, which also lists 5 linked publications.
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 3 Jan 2022.