Early Intervention, Educational (Head Start and Early Head Start Access and Participation)HSREACHNCT05145933
Head Start REACH: Strengthening Outreach, Recruitment and Engagement Approaches With Families
An observational study of Early Intervention, Educational (Head Start and Early Head Start Access and Participation), run by Mathematica Policy Research, Inc. at 1 site in United States.
Trial summary
Mathematica, funded by the Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) in the U.S. Department of Health and Human Services (HHS) will collect descriptive information for the Head Start REACH: Strengthening Outreach, Recruitment and Engagement Approaches with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Intervention, Educational (Head Start and Early Head Start Access and Participation)
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 30 Jun 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Head Start program directors; Head Start staff involved in implementing eligibility, recruitment, selection, enrollment, and attendance (ERSEA) activities; staff in community organizations with which the Head Start program partners to serve families experiencing adversities; families who are enrolled in Head Start programs; and families who are eligible for but not enrolled in Head Start programs.
Who may be able to join
- Program director at Head Start program
- ERSEA staff members at Head Start program
- Staff at community partner organizations
- Families enrolled in program at Head Start program
- Families not enrolled in Head Start program but being served by the community partner organization
Who cannot join
- Does not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Mathematica
Washington D.C., District of Columbia, 20002-4221
Louisa Tarullo, 617-588-6720, ltarullo@mathematica-mpr.com
Harshini Shah, 617-674-8360, hshah@mathematica-mpr.com
About this study
Mathematica, funded by the Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) in the U.S. Department of Health and Human Services (HHS) will collect descriptive information for the Head Start REACH: Strengthening Outreach, Recruitment and Engagement Approaches with Families (Head Start REACH) study. The investigators will conduct qualitative case studies in six sites. The goal of these case studies in the Head Start REACH study is to provide an in-depth understanding of (1) the approaches that are likely to be successful for the recruitment, selection, enrollment, and retention (RSER) of families who are experiencing adversities; (2) the factors that affect the implementation of these approaches and; (3) the experiences of such families, both enrolled and non-enrolled in Head Start.
Data collection will occur in spring 2022. The investigators will conduct qualitative, semi-structured interviews with staff across the six sites who are involved in RSER efforts and provide services to families experiencing adversities, including those in Head Start programs and in the community organizations with which the programs partner. The investigators will also conduct focus groups with families who are being served by Head Start programs and/or the community partner organizations.
Read the detailed description
This study aims to advance understanding of the approaches that programs use for the recruitment, selection, enrollment, and retention (RSER) of families who are experiencing adversities; the implementation of those approaches; and the experience of Head Start-eligible families (both enrolled and not enrolled in Head Start). Adversities is a broad term that refers to a wide range of circumstances or events that pose a threat to a child or caregiver's physical or psychological well-being. The adversities that families experience are often intertwined with poverty, may co-occur, and are affected by systematic factors, such as structural racism. Common examples include (but are not limited to) families experiencing homelessness; involvement in child welfare, including foster care; and affected by substance use, mental health issues, and domestic violence. Data from these case studies will inform the development of the study's conceptual framework, identify knowledge gaps, and inform the design of a future large-scale descriptive study. Ultimately, this information collection will support ACF in better understanding how Head Start programs recruit, select, enroll, and retain families and inform Head Start's efforts to achieve its mission of advancing equitable outcomes for children and families. In addition, these case studies may identify promising approaches for engaging underserved populations and help Head Start utilize more effective case management and coordination strategies.
The information collected is meant to contribute to the body of knowledge on ACF programs. It is not intended to be used as the principal basis for a decision by a federal decision-maker and is not expected to meet the threshold of influential or highly influential scientific information.
The investigators propose the following data collection activities, to be carried out in spring 2022:
- A semi-structured program director interview: To obtain information about the Head Start program's eligibility, recruitment, selection, enrollment, and attendance (ERSEA) policies; RSER approaches and how they are tailored for families facing adversities; staff training and support related to RSER and adversities; RSER approaches used with underserved families; and partnerships that support the program's RSER efforts.
- A semi-structured Head Start ERSEA staff interview: To obtain information about the Head Start program's ERSEA policies; RSER approaches and how they are tailored for families facing adversities; staff training and support related to RSER and adversities; RSER approaches used with underserved families; and partnerships that support the program's RSER efforts.
- A semi-structured community partner staff interview: To collect information about the community organization's experience working with the Head Start program and their referral processes; the organization's understanding of Head Start eligibility criteria; the organization's procedures for disseminating information about early education and child care options to families; and the organization's view of the Head Start program's role in meeting families' needs.
- A focus group with families enrolled in Head Start: To collect information on the families' experience with the Head Start program; the recruitment and post-enrollment experience in the Head Start program; and the likelihood of the family's continuing its involvement in the Head Start program.
- A focus group with Head Start-eligible families not enrolled in Head Start: To obtain information on the families' experience with the community partner organization; knowledge of Head Start program and alternate early education and child care options; barriers to enrollment in the Head Start program; and the reasons families choose alternative child care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Staff Interview Protocol on Promising RSER Approaches: Program Director
Study developed qualitative protocol will collect data on Head Start program approaches used for the recruitment, selection, enrollment, and retention (RSER) of families facing adversities and report on the most promising RSER approaches.
Measured: 1 month
Program Staff Interview Protocol on Promising RSER Approaches: ERSEA Staff
Study developed qualitative protocol will collect data on Head Start program approaches used for the RSER of families facing adversities and report on the most promising RSER approaches.
Measured: 1 month
Focus Group Guide for Head Start Enrolled Families on Head Start Recruitment and Post-enrollment Experiences
Study developed qualitative protocol will collect data on the recruitment and post-enrollment experience of families experiencing adversities who are enrolled in Head Start programs and report on the factors that facilitate successful enrollment and retention of these families.
Measured: 1 month
Community Partner Staff Interview Protocol on Factors that Support RSER
Study developed qualitative protocol will collect data and report on the factors that support the Head Start program's RSER of families experiencing adversities
Measured: 1 month
Focus Group Guide for Families Not Enrolled in Head Start on Barriers to Head Start Participation
Study developed qualitative protocol will collect data on the experience of families experiencing adversities who are not enrolled in Head Start programs and report on the factors that prevent their participation.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start3 Jan 2022 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Intervention, Educational (Head Start and Early Head Start Access and Participation)Studies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Boston Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145933
- Sponsor's protocol ID
- 51075
- Acronym
- HSREACH
- Status last verified
- Sep 2021
- First submitted
- 29 Oct 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information about program-level respondents and respondents from community partner organizations will be kept private to the extent permitted by law; information about parents who participate in the focus groups will be kept private to the extent permitted by law. Any data shared for the project will be shared in summary form.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Start REACH: Strengthening Outreach, Recruitment and Engagement Approaches With Families
- ClinicalTrials.gov ID
- NCT05145933
- Acronym / sponsor ID
- HSREACH / 51075
- Conditions
- Early Intervention, Educational (Head Start and Early Head Start Access and Participation)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Department of Health and Human Services, Boston Children's Hospital
- Study start
- 3 Jan 2022 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 6 Dec 2021 (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.
Mathematica, funded by the Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) in the U.S. Department of Health and Human Services (HHS) will collect descriptive information for the Head Start REACH: Strengthening Outreach, Recruitment and Engagement Approaches with Families (Head Start REACH) study. The investigators will conduct qualitative case studies in six sites. The goal of these case studies in the Head Start REACH study is to provide an in-depth understanding of (1) the approaches that are likely to be successful for the recruitment, selection, enrollment, and retention (RSER) of families who are experiencing adversities; (2) the factors that affect the implementation of these approaches and; (3) the experiences of such families, both enrolled and non-enrolled in Head Start.
Data collection will occur in spring 2022. The investigators will conduct qualitative, semi-structured interviews with staff across the six sites who are involved in RSER efforts and provide services to families experiencing adversities, including those in Head Start programs and in the community organizations with which the programs partner. The investigators will also conduct focus groups with families who are being served by Head Start programs and/or the community partner organizations.
Detailed description
This study aims to advance understanding of the approaches that programs use for the recruitment, selection, enrollment, and retention (RSER) of families who are experiencing adversities; the implementation of those approaches; and the experience of Head Start-eligible families (both enrolled and not enrolled in Head Start). Adversities is a broad term that refers to a wide range of circumstances or events that pose a threat to a child or caregiver's physical or psychological well-being. The adversities that families experience are often intertwined with poverty, may co-occur, and are affected by systematic factors, such as structural racism. Common examples include (but are not limited to) families experiencing homelessness; involvement in child welfare, including foster care; and affected by substance use, mental health issues, and domestic violence. Data from these case studies will inform the development of the study's conceptual framework, identify knowledge gaps, and inform the design of a future large-scale descriptive study. Ultimately, this information collection will support ACF in better understanding how Head Start programs recruit, select, enroll, and retain families and inform Head Start's efforts to achieve its mission of advancing equitable outcomes for children and families. In addition, these case studies may identify promising approaches for engaging underserved populations and help Head Start utilize more effective case management and coordination strategies.
The information collected is meant to contribute to the body of knowledge on ACF programs. It is not intended to be used as the principal basis for a decision by a federal decision-maker and is not expected to meet the threshold of influential or highly influential scientific information.
The investigators propose the following data collection activities, to be carried out in spring 2022:
- A semi-structured program director interview: To obtain information about the Head Start program's eligibility, recruitment, selection, enrollment, and attendance (ERSEA) policies; RSER approaches and how they are tailored for families facing adversities; staff training and support related to RSER and adversities; RSER approaches used with underserved families; and partnerships that support the program's RSER efforts.
- A semi-structured Head Start ERSEA staff interview: To obtain information about the Head Start program's ERSEA policies; RSER approaches and how they are tailored for families facing adversities; staff training and support related to RSER and adversities; RSER approaches used with underserved families; and partnerships that support the program's RSER efforts.
- A semi-structured community partner staff interview: To collect information about the community organization's experience working with the Head Start program and their referral processes; the organization's understanding of Head Start eligibility criteria; the organization's procedures for disseminating information about early education and child care options to families; and the organization's view of the Head Start program's role in meeting families' needs.
- A focus group with families enrolled in Head Start: To collect information on the families' experience with the Head Start program; the recruitment and post-enrollment experience in the Head Start program; and the likelihood of the family's continuing its involvement in the Head Start program.
- A focus group with Head Start-eligible families not enrolled in Head Start: To obtain information on the families' experience with the community partner organization; knowledge of Head Start program and alternate early education and child care options; barriers to enrollment in the Head Start program; and the reasons families choose alternative child care.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Head Start program directors; Head Start staff involved in implementing eligibility, recruitment, selection, enrollment, and attendance (ERSEA) activities; staff in community organizations with which the Head Start program partners to serve families experiencing adversities; families who are enrolled in Head Start programs; and families who are eligible for but not enrolled in Head Start programs.
Key inclusion criteria (5 listed)
- Program director at Head Start program
- ERSEA staff members at Head Start program
- Staff at community partner organizations
- Families enrolled in program at Head Start program
- Families not enrolled in Head Start program but being served by the community partner organization
Key exclusion criteria (1 listed)
- Does not meet the inclusion criteria
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
Program Staff Interview Protocol on Promising RSER Approaches: Program Director
Time frame: 1 month
Study developed qualitative protocol will collect data on Head Start program approaches used for the recruitment, selection, enrollment, and retention (RSER) of families facing adversities and report on the most promising RSER approaches.
Program Staff Interview Protocol on Promising RSER Approaches: ERSEA Staff
Time frame: 1 month
Study developed qualitative protocol will collect data on Head Start program approaches used for the RSER of families facing adversities and report on the most promising RSER approaches.
Focus Group Guide for Head Start Enrolled Families on Head Start Recruitment and Post-enrollment Experiences
Time frame: 1 month
Study developed qualitative protocol will collect data on the recruitment and post-enrollment experience of families experiencing adversities who are enrolled in Head Start programs and report on the factors that facilitate successful enrollment and retention of these families.
Community Partner Staff Interview Protocol on Factors that Support RSER
Time frame: 1 month
Study developed qualitative protocol will collect data and report on the factors that support the Head Start program's RSER of families experiencing adversities
Focus Group Guide for Families Not Enrolled in Head Start on Barriers to Head Start Participation
Time frame: 1 month
Study developed qualitative protocol will collect data on the experience of families experiencing adversities who are not enrolled in Head Start programs and report on the factors that prevent their participation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: No. Information about program-level respondents and respondents from community partner organizations will be kept private to the extent permitted by law; information about parents who participate in the focus groups will be kept private to the extent permitted by law. Any data shared for the project will be shared in summary form.
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.
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 Early Intervention, Educational (Head Start and Early Head Start Access and Participation), run by Mathematica Policy Research, 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 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: status not confirmed, as of the sponsor's last update on 6 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louisa Tarullo, EdD (617-588-6720, ltarullo@mathematica-mpr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Staff Interview Protocol on Promising RSER Approaches: Program Director (time frame: 1 month). The study lists 5 primary outcomes in all. 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 6 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.