Migrant and Seasonal Head StartMSHSNCT03116243
Migrant and Seasonal Head Start Study
An observational study of Migrant and Seasonal Head Start, run by Abt Associates at 1 site in United States.
Trial summary
The MSHS Study is a nationally representative study commissioned by the U.S. Office of Health and Human Services' Administration for Children and Families that will describe the characteristics and experiences of the children and families who enroll in MSHS and the practices and services of the MSHS programs that… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migrant and Seasonal Head Start
- How many people
- 1,404 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2017to 30 Apr 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes children birth to five years who attend Migrant Seasonal Head Start (MSHS) programs, along with their parents and teachers, center directors, and program directors.
Who may be able to join
- infants, toddlers, and preschoolers in participating Migrant and Seasonal Head Start centers/classrooms across the U.S. and their teachers and parents. Also includes center directors and program directors.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Abt Associates, Inc.
Washington D.C., District of Columbia, 20201
About this study
Official title: Migrant and Seasonal Head Start (MSHS) Study
The MSHS Study is a nationally representative study commissioned by the U.S. Office of Health and Human Services' Administration for Children and Families that will describe the characteristics and experiences of the children and families who enroll in MSHS and the practices and services of the MSHS programs that serve them. The MSHS Study draws heavily on the Design for MSHS Survey Report (2011) and is informed by the current context of key policy and programmatic issues and broader issues impacting the lives of migrant and seasonal farmworkers and their families.
The MSHS Study has two components: a Program/Center component and a Classroom, Family, Child component that are based on distinct samples. The first component is off-site and consists of mailed surveys that will be sent to the universe of MSHS program directors and a representative subset of center directors to provide information on program and center operations. The second component consists of onsite data collection - including classroom observations, surveys with teachers and assistant teachers, parent interviews, teacher and parent child reports, and direct child assessments - with a nationally-representative sample of centers, classrooms, families and children.
Once data are collected, the study will address a set of research questions that can be summarized into three broad categories: (1) What are the characteristics of MSHS programs, families, and children? (2) What services do MSHS programs provide, what instructional and language practices are used, and what is the quality of MSHS classrooms? and (3) What are the associations between MSHS characteristics and child/family well-being?
- Conditions
- Migrant and Seasonal Head Start
- Keywords
- migrant and seasonal head start, early childhood education, head start
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MSHS children and families | Cohort includes: * children (1272) * parents (1272) * teachers (159) * teaching assistants (159) * program and center directors (253) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language Literacy
Indicators of language literacy will be assessed during week-long site visits using Letter-Word Identification \& "Identificación de letras y palabras" in the Woodcock-Muñoz Language Survey.
Measured: 1 year
Emergent Literacy
Indicators of emergent literacy will be assessed during week-long site visits using the Spanish Version (or English version for children who are not Spanish speakers) of the PLS-5 Auditory Comprehension subscale.
Measured: 1 year
Emotional Skills
Indicators of emotional skills will be assessed during week-long site visits using the Cognitive/ Social and Emotional/Regulations Scales from the Leiter-Third Edition Examiner Rating Scales.
Measured: 1 year
Classroom Quality
Classroom quality will be assessed during the week-long site visits using the Early Language and Literacy Classroom Observation (ELLCO) Tool and the Classroom Assessment Scoring System™ (CLASS™).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start4 Mar 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migrant and Seasonal Head StartStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abt Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of America, Westat
- Responsible party
- Sponsor
- Investigators
- Sandra Barrueco, Ph.D., Principal investigator, The Catholic Univeristy of AmericaMichael L Lopez, Ph.D., Principal investigator, Abt AssociatesLinda Caswell, Ed.D., Study director, Abt Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116243
- Sponsor's protocol ID
- MSHS
- Acronym
- MSHS
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The MSHS Study team will prepare restricted use datasets and documentation, to be archived with a data storage site such as the Inter-university Consortium for Political and Social Research (ICPSR) at the University of Michigan, so that future researchers may use the MSHS Study data to replicate findings and explore new areas of inquiry.
Publications
O'Brien RW, Barrueco S, Lopez ML, D'Elio ML. Design for Migrant and Seasonal Head Start Survey. Washington, D.C.: Administration for Children and Families, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migrant and Seasonal Head Start (MSHS) Study
- ClinicalTrials.gov ID
- NCT03116243
- Acronym / sponsor ID
- MSHS / MSHS
- Conditions
- Migrant and Seasonal Head Start
- Keywords
- migrant and seasonal head start, early childhood education, head start
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,404 participants (actual)
- Lead sponsor
- Abt AssociatesIndustry (pharma, biotech, devices)
- Collaborators
- The Catholic University of America, Westat
- Study start
- 4 Mar 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 17 Apr 2017 (actual)
- 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 MSHS Study is a nationally representative study commissioned by the U.S. Office of Health and Human Services' Administration for Children and Families that will describe the characteristics and experiences of the children and families who enroll in MSHS and the practices and services of the MSHS programs that serve them. The MSHS Study draws heavily on the Design for MSHS Survey Report (2011) and is informed by the current context of key policy and programmatic issues and broader issues impacting the lives of migrant and seasonal farmworkers and their families.
The MSHS Study has two components: a Program/Center component and a Classroom, Family, Child component that are based on distinct samples. The first component is off-site and consists of mailed surveys that will be sent to the universe of MSHS program directors and a representative subset of center directors to provide information on program and center operations. The second component consists of onsite data collection - including classroom observations, surveys with teachers and assistant teachers, parent interviews, teacher and parent child reports, and direct child assessments - with a nationally-representative sample of centers, classrooms, families and children.
Once data are collected, the study will address a set of research questions that can be summarized into three broad categories: (1) What are the characteristics of MSHS programs, families, and children? (2) What services do MSHS programs provide, what instructional and language practices are used, and what is the quality of MSHS classrooms? and (3) What are the associations between MSHS characteristics and child/family well-being?
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSHS children and families | – | –Cohort includes: * children (1272) * parents (1272) * teachers (159) * teaching assistants (159) * program and center directors (253) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes children birth to five years who attend Migrant Seasonal Head Start (MSHS) programs, along with their parents and teachers, center directors, and program directors.
Key inclusion criteria (1 listed)
- infants, toddlers, and preschoolers in participating Migrant and Seasonal Head Start centers/classrooms across the U.S. and their teachers and parents. Also includes center directors and program directors.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Language Literacy
Time frame: 1 year
Indicators of language literacy will be assessed during week-long site visits using Letter-Word Identification \& "Identificación de letras y palabras" in the Woodcock-Muñoz Language Survey.
Emergent Literacy
Time frame: 1 year
Indicators of emergent literacy will be assessed during week-long site visits using the Spanish Version (or English version for children who are not Spanish speakers) of the PLS-5 Auditory Comprehension subscale.
Emotional Skills
Time frame: 1 year
Indicators of emotional skills will be assessed during week-long site visits using the Cognitive/ Social and Emotional/Regulations Scales from the Leiter-Third Edition Examiner Rating Scales.
Classroom Quality
Time frame: 1 year
Classroom quality will be assessed during the week-long site visits using the Early Language and Literacy Classroom Observation (ELLCO) Tool and the Classroom Assessment Scoring System™ (CLASS™).
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 11 Jan 2019.
- BackgroundO'Brien RW, Barrueco S, Lopez ML, D'Elio ML. Design for Migrant and Seasonal Head Start Survey. Washington, D.C.: Administration for Children and Families, 2011.
- Design for Migrant and Seasonal Head Start SurveyLink provided by the sponsor.
- Migrant and Seasonal Health Start Study WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The MSHS Study team will prepare restricted use datasets and documentation, to be archived with a data storage site such as the Inter-university Consortium for Political and Social Research (ICPSR) at the University of Michigan, so that future researchers may use the MSHS Study data to replicate findings and explore new areas of inquiry.
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.
Sandra Barrueco, Ph.D. principal investigator
The Catholic Univeristy of America
Michael L Lopez, Ph.D. principal investigator
Abt Associates
Linda Caswell, Ed.D. study director
Abt Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migrant and Seasonal Head Start, run by Abt Associates 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 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 11 Jan 2019. 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?
Language Literacy (time frame: 1 year). The study lists 4 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 NCT03116243, which also lists 1 linked publication.
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 11 Jan 2019.