Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03499405 |
| Other study ID # |
CIN001-HeadStart Navigator Int |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2017 |
| Est. completion date |
June 30, 2018 |
Study information
| Verified date |
July 2018 |
| Source |
Children's Hospital Medical Center, Cincinnati |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Headstart (HS) is an early childhood education program for low-income children. Preliminary
analyses of Hamilton County HS preschoolers with developmental concerns identified 26% with
"severe concern" necessitating developmental testing, and only 47% followed-through when some
developmental concern was identified. Those less likely to follow-through were African
American or Hispanic, lived in larger families, or had asthma. Cultural and economic factors
are known barriers to earlier diagnosis of children with developmental disabilities (DD)
among African American, Hispanic and low-income children. Given that HS children are
low-income and culturally diverse, preschoolers are likely to face barriers to early
identification of DD and subsequently kindergarten readiness. Patient navigator programs are
effective interventions for vulnerable populations to improve health care access, increase
treatment adherence, enhance trust in health care systems, and reduce health care costs. A
family (FN) intervention that is culturally-adapted to promote caregiver follow-through, and
undergirded by HS's mission of kindergarten success may effectively increase caregiver
adherence to developmental testing. The goal of this study is to develop and pilot test a FN
intervention in HS that is executed by peer-to-peer navigators to improve adherence with
developmental testing in high-risk preschoolers.
Description:
Headstart (HS) is a pipeline for early school success for low-income children aged 3-5 years,
and provides health promotion services such as developmental monitoring to promote school
readiness. In 2014-2015 Hamilton County Headstart (HCHS) identified 968 of 2987 preschoolers
(32%) with developmental concern, with 251 (26%) identified as "severe concern" necessitating
developmental testing. Yet, follow-through with testing did not occur for 53 high-risk
preschoolers (21%), and only 451 (47%) followed-through when some developmental concern was
identified. Those less likely to follow-through were African American or Hispanic, lived in
families of 3 or more, or had asthma. That race and ethnicity predict insufficient
follow-through is not surprising; cultural and economic factors are known barriers to earlier
diagnosis of children with developmental disabilities (DD), resulting in 2 year lags in
obtaining DD diagnoses among African American, Hispanic and low-income children and placing
them at risk for worse long-term prognosis. Diagnostic disparities are also grounded in the
social factors of poorer health care access, caregiver distrust of health systems, knowledge
deficits, and stigma about disability. One mechanism thought to contribute to the diagnostic
delays is caregiver postponement in obtaining developmental assessments due to these
collective factors. Given that all HS children are low-income and a majority are African
American or Hispanic, HS preschoolers are likely to face barriers to early identification of
DD and subsequently kindergarten readiness. An intervention that addresses the salient
barriers to developmental assessment for HS preschoolers could advance pre-academic abilities
and promote access to earlier recognition and treatment of DD, leading to improved health
outcomes.
Patient navigator programs have been effective interventions for vulnerable populations to
improve health care access, increase treatment adherence, enhance trust in health care
systems, and reduce health care costs. Despite these findings, investigations into peer-based
navigation interventions for families of children with inferior health outcomes have mostly
been program evaluations or unpublished clinical trials. A promising study in Developmental
and Behavioral Pediatrics (DBP) on family navigators (FN) for children referred from primary
care for evaluation of DD is examining family quality of life outcomes prior to and after DD
diagnoses, and has shown preliminary success in developing and training FNs. A FN
intervention that is culturally-adapted to promote caregiver follow-through, and undergirded
by HS's mission of kindergarten readiness may effectively increase caregiver adherence to
developmental testing in HS. The goal of this study is to refine and pilot test a FN
intervention that is informed by HS caregivers, staff and primary care providers (PCP),
grounded in the HS community, and executed by peer-to-peer navigators to improve adherence
with developmental testing in high-risk preschoolers. This study is the final year of a
research program that will focus on tailoring the elements of a community-based (Head Start
(HS) Family Navigator (FN) intervention for high risk children with developmental concerns in
order to improve access to developmental testing. This study will be conducted over a 1 year
period with the specific aim outlined below.
The study titled: Prototype of a Head Start Navigator Intervention for Child Developmental
Testing (IRB#2016-4253) was conducted to develop a community-based family navigator
intervention for preschoolers identified in HS as high-risk for developmental delay. Focus
groups were conducted with caregivers, teachers and primary care providers (PCPs) to
understand the barriers and facilitators to follow-through with developmental testing. The
prototype was tailored to the thematic focus group findings, cultural and risk factors
previously identified, and results of an updated analysis of predictors of poor
follow-through of developmental assessments from HCHS academic year 2015-2016 (IRB#
2016-4253). Findings confirmed that primary care and Head Start operate in silos regarding
developmental screening and follow-through for at-risk children. Facilitating factors to
caregiver follow-through were identified as: building relationships, increasing resource
knowledge, and addressing denial/stigma of disability. Findings substantiated that caregivers
needed assistance with navigating developmental testing, and valued its delivery using a
peer-to-peer approach that was culturally-matched. The intervention was adapted from the
crucial components necessary for a successful Family Navigator training program and delivery
of the intervention including elements of frequency, duration and intensity that were also
confirmed by the findings.
Materials and Methods
Study Purpose:
The study purpose is to test a community-based family navigator intervention for preschoolers
identified in HS as high-risk for developmental delay. The community-based intervention will
train racially/ethnically matched peer caregivers in HS as FNs. FNs from HS will guide and
support caregivers to follow-through with child developmental testing. The investigators will
test if a Head Start FN program is feasible, acceptable and health-promoting.
Specific Aims:
Aim 1: Pilot test a community-based FN intervention in HS that trains peer caregivers as FNs
to guide and support caregivers to follow-through with child developmental testing. The
investigators will test if an adapted model of a FN program that includes racially/ethnically
matched peers, trained to support and guide caregivers through child developmental testing,
is feasible, acceptable and health-promoting.
Key outcomes are: 1) proportion of children who complete developmental testing guided by FNs
(feasibility), 2) caregiver, FN, teacher and PCP satisfaction with the intervention and its
implementation (acceptability), and 3) caregivers' and FNs' knowledge of development and
disparities in early DD recognition (health promotion).
Study Settings:
1. The study settings will be multiple with the primary setting being Hamilton County Head
Start centers from CAA (Community Action Agency) and ESC (Educational Services Center).
HS is a federally-funded program providing preschool education and kindergarten
preparation. HS establishes partnerships with caregivers and communities by identifying
and building on family and community strengths. Both informally and formally through
parent groups and committees, caregivers are empowered to participate in HS curriculum
planning and make decisions regarding their children's education. HS encompasses urban
and suburban center-based programs serving income-eligible families of children 3-5
years old.
2. Additional study settings will be the caregiver's home, developmental testing sites such
as primary care provider office, Cincinnati Children's Hospital Medical Center, Division
of Developmental and Behavioral Pediatrics (DDBP) outpatient clinic, therapy evaluation
and treatment centers (i.e. speech, occupational, physical therapies), local school, and
community locations that are mutually determined between caregiver and FN.
Participants:
1. FN participants will be current, former, or pending HS parents, or a parent of a child
with a developmental disability who has experience with HS, and sampled from urban and
suburban HS. Eight FNs will be trained to support and guide caregivers through
developmental testing, including 4 African American, 1 Caucasian and 3 bi-lingual
Hispanic parents. Each FN will be assigned 1 to 5 caregivers.
2. The study sample of caregiver participants will include 32 eligible HS caregivers of
preschoolers between 3 and 5 years old identified with moderate or severe developmental
concerns on HS developmental screening, in order to include those at-risk before
kindergarten age. Those with moderate developmental concern will have failed 2 domains
on developmental screening, whereas those with severe concern have failed 3 or more
domains. Those who fail 1 domain (mild concern) will be excluded since often single
domain failures are due to limited early learning exposures and/or language barriers,
which can be adequately addressed in HS. Half of those selected will be sampled from the
moderate and half from the severe group, with 50% from urban and 50% from suburban HS
centers included. Given that the demographics differ slightly in racial and ethnic
make-up among the urban and suburban Head Starts, 12 African American, 2 Caucasian and 2
Hispanic caregivers will be sampled from urban HS; in suburban HS, 8 African American, 6
Caucasian and 2 Hispanic caregivers will be sampled.
Procedures:
Recruitment:
Family Navigator recruitment: Eligible FN participants will be current, former, or pending HS
parents, or a parent of a child with a developmental disability who has experience with HS,
and sampled from urban and suburban HS. Recruitment will occur via purposeful sampling from
HS staff, parent advisory groups, and previously completed focus group participants (IRB#
2016-4253).
Caregiver recruitment: Eligible caregiver participants will be selected for the intervention
and control (usual care) groups using stratified block random sampling by race, level of
developmental concern and within each urban and suburban HS center. HS database will be
accessed retrospectively for the intervention and control groups. Since HS developmental
screening is completed within 45 days of enrollment, selection will begin once all HS
screening has been completed. The investigators will abstract data on severity of concern and
whether developmental referrals were completed.
Study Procedure:
The intervention includes a training and navigation component. The training and navigation
components will be adapted from an existing DDBP FN program and integrated with the
intervention development features from the previous prototype study. The FN training
component will be built from the DDBP FN curriculum and include training in: 1)
confidentiality and HIPAA, 2) safety issues and reporting concerns, 3) disparities in
identification of developmental delay and importance of early developmental testing, 4) HS
and primary care and other developmental services, and 5) peer mentoring skills. The training
will be provided by the research team, including consultation with HS staff and the DDBP FN.
Training will include 6 hours of didactic and interactive sessions in a workshop format. The
navigation component will also be developed from the DDBP FN program and generally comprise
the FN role of guiding and supporting caregivers in navigating the educational and health
care interfaces. The primary interfaces between FN and caregiver participants can include,
but are not limited to: 1) HS identification of child at-risk for developmental concern, 2)
HS and PCP communication about the child's ongoing developmental concerns and the plan for
further testing/treatments, and 3) results sharing. Non-English speaking caregivers will be
provided a translator for on-site HS or developmental meetings as a standard of care. The FN
will build a supportive relationship with the caregiver by facilitating and guiding at each
of the above interfaces through in-person meetings, attending testing and results, and
facilitating communication at every interface. Intermittent FN contact with caregivers
between meetings may also take the form of phone calls, texts or emails, as determined by the
FN/caregiver dyad. The research team will assess the FN fidelity to the intervention with
focus on the FN/caregiver dyad relationship at the mid-intervention caregiver/FN encounter.
Family navigation will cease at the end of the academic year, with transitions facilitated to
social service or health care agencies for severe needs not fully addressed. The navigation
component will comprise about 5 two-hour meetings among the FN/caregiver dyad during the
academic year.
The caregiver intervention group will include those caregivers' whose children fail 2 or more
developmental domains on HS screening and will be referred for usual care in Head Start, such
as follow up with primary care or school district testing . The investigators will request
the caregivers share the results of any follow up visits for development (ie. with primary
care or school district) with the Family Navigator, and subsequently the research team.
Results will be tracked until the end of the study. The control group will be assessed from
the HS database retrospectively, including access to usual care (e.g. outside referral for
developmental testing in school district or primary care) when identified by HS with
developmental concern.
Investigator-developed questionnaires in English or Spanish on knowledge of health
disparities in DD and the importance of developmental testing will be administered to FNs and
caregivers pre-and-post navigator intervention. Investigator-developed questionnaires on
satisfaction and implementation of the intervention will be administered to FNs, caregivers,
teachers and PCP post-intervention. Teacher and PCP questionnaires will ascertain additional
factors of communication of developmental concerns between Head Start and Primary Care, and
the navigator interfaces with each site. Demographic information on caregiver age,
race/ethnicity, language, family size, employment, income, education, and marital status will
be collected from HS records. Demographics on child age, health screenings and conditions,
and HS attendance will be obtained from HS records. Completion of developmental referrals
will be obtained from HS database for the intervention and control groups.
Outcome Measures:
Key outcomes for this study are: 1) proportion of children who complete developmental testing
guided by FNs (feasibility), 2) caregiver, FN, teacher and PCP satisfaction with the
intervention and its implementation (acceptability), and 3) caregivers' and FNs' knowledge of
development and disparities in early DD recognition (health promotion).
The primary outcome is the proportion of children who complete referrals for developmental
testing in the intervention group relative to the control group, with the hypothesis that the
FN intervention will increase caregiver completion of referrals and time to completion is
less than those in the control group (feasibility). Secondary outcomes are: 1) caregiver, FN,
teacher and PCP satisfaction with the intervention and implementation (acceptability) and 2)
caregiver and FN knowledge of child developmental disparities (health promotion).
Data Analysis:
The sample size of 32 caregiver participants was selected because the capacity for FNs to be
trained and intervene is limited to 5 families for each of the 8 navigators, as this is a new
intervention within the HS setting and feasible for newly-trained FNs in a pilot study. To
assess the primary outcome, the proportion of children who complete referrals for testing
will be compared between caregivers who receive the intervention and those in the control
group. Participants (caregivers) will be randomized to receive either the family navigator
intervention or control (usual care process) groups using stratified block random sampling by
race and within each center (CAA, ESC). To compare the difference in the time from referral
to testing between groups, survival analyses (e.g. Cox proportional hazards modeling) will be
used. Preliminary analysis of HS caregiver completion of referral (the primary outcome of our
proposed study) indicated that approximately 50% of caregivers across all groups completed a
referral. With 32 moderate and severe risk preschoolers per group (32 in intervention and 32
in non-intervention), using a chi-square test with 2-sided significance level set at α=0.05
the investigators will have >90% power to detect an increase of 50% to 90% of caregivers
completing the referral. Secondary outcomes include the time to completion of referrals, and
acceptability and knowledge of the intervention as measured by investigator-developed
instruments. These analyses will provide effect sizes for investigator-development
instruments, and will enable power calculations for a subsequent R21 proposal testing random
allocation of a FN intervention. Costs and labor of the intervention vs. the control group
will be analyzed using means and ratios of labor costs, materials, transportation,
caregiver's time off work, retention and health services use to facilitate development of
procedures for wider dissemination and sustainability. The aggregate of these measures will
assist our evaluation of the components needed to provide a timely, coordinated approach to
follow-through with developmental testing for moderate and severe at-risk preschoolers in HS.
Generalizability will be constrained by the sample size and the local sample represented,
with the objective at present being to conduct a pilot intervention study. Caregiver
demographic characteristics will be assessed for distribution of the data using means and
standard deviations or medians and ranges as appropriate to the data.
Data Storage All electronic data and data analysis results will be stored on a
password-protected limited-access network drive. Names will not be associated with the
participants or risk analyses data. Only the personnel directly involved in the study will
have access to the data.
Risk and Benefit to Participants The study poses minimal risk and may have no direct benefit
to individuals participating in the study. However this study has the potential to add to our
understanding regarding the feasibility of peer-matched navigators guiding caregiver
follow-through to developmental recommendations for high-risk preschoolers. Despite having no
immediate and direct benefit for the study participants, participation may benefit caregivers
in obtaining developmental resources for their at-risk preschooler, and may benefit FN
participants by participation in resource training.
Potential Risks, Discomforts, Inconveniences, and Precautions There is minimal risk for this
study. Participants include caregivers of preschoolers enrolled in HS, current or former or
pending HS parents (the family navigator participants), HS teachers and primary care
providers (PCPs). Caregiver participants will be sampled to represent the cultural diversity
of HS parents because the investigators are seeking to understand the feasibility of a
culturally-matched peer navigator intervention to increase follow-through with developmental
testing. Caregivers whose primary language is Spanish will be included and interpreter
services available.
For caregiver participants it is unlikely, but possible, that after consenting they may feel
uncomfortable with the emotional content around their child at-risk for developmental
concerns, and if this is the case, have the right to withdraw from the study at any time. It
will be reinforced in the consent that participation is voluntary, and if the process is
uncomfortable for the participants they may withdraw at any time. Community resources will be
offered if needed. Members of the research team will comply with requests to withdraw or no
longer participate.
Private space in HS will be provided for meetings between FN and caregiver participants as
needed. Caregiver participant demographics will be obtained from HS database and shared only
with the research team. Caregiver, FN, teacher and PCP data from questionnaires will be
shared only with the research team. Control group demographics will be obtained from HS
database, and shared only in aggregate form. All sources will be de-identified.
Confidentiality Loss of confidentiality or privacy is another possible risk for the
participants. To reduce these risks, the FN training will include the need to protect
caregiver participant confidentiality (e.g HIPPA and FERPA) and caregivers will be informed
that the FN and Caregiver meetings constitute questions and answers in a dyad. Participant
names will be known only to the research team, HS site coordinators and the assigned Family
Navigator. Only personnel directly associated with the study will have access to the data.
Participant information and study results will be reported in aggregate. Risk analyses are
conducted from de-identified data in aggregate. No identifying information will be included
in scientific reports, presentations, or publications.
Method to be used in Procuring Consent of Participants The research involves no more than
minimal risk to the participants and will not adversely affect the rights or welfare of the
participants. All Family Navigator and Caregiver participants will be fully informed and
consented for their participation. The caregiver consent form will also give parental
permission for their child (age 3-5) to participate in developmental testing at CCHMC. A
member of the research team will review the study information and consent with the
participants using lay language. The participants will be given an opportunity to ask
questions about the study. Participants will be informed that they have the right to stop
participating at any time. Participation is always voluntary. The participants will be given
the consent to take home to make an informed and independent decision regarding whether to
participate in the research. For Spanish-speaking participants, the consent will be conducted
with a Spanish-speaking translator available during consent. In addition, the investigators
will translate the consent form to Spanish using the CCHMC interpreter services after IRB
approval. This will be certified, and submitted to the IRB.
Additionally, approximately 25% of the Family Navigator and Caregiver participants may be
Latino immigrants, a vulnerable population, who may be undocumented and/or illiterate. Having
the Latino participants sign their name to a consent form would have the potential for
putting the immigrant participants at risk for harm about their legal status, harm from a
breach of confidentiality, and they may not be able to write their name if illiterate. For
these participants, only first names will be recorded and/or linked to any information that
is discussed.
Data and Safety Monitoring Plan This proposal is a pilot test of a clinical trial, and as
such it will be registered at www.clinicaltrials.gov. Although given the nature of the study
the investigators do not expect to have serious adverse events, the investigators are
prepared to address these appropriately should they occur. The PI will be available on cell
phone at all times. All numbers will be provided to all participants. Adverse events will be
brought to the immediate attention of the PI through the investigative team, Head Start staff
or any study participants. For recruitment of participants the PI will be available on cell
phone at all times. The PI will be available at all times for any questions from the family
navigators or caregiver participants about any aspects of the study. Satisfaction with the
intervention will be assessed at specified intervals with questionnaires given to
participants and an open-ended comment section included in the questionnaire. The PI or CRC
will review all data as it is collected to monitor for safety issues. The PI will be notified
immediately of any safety issues. Adverse events will require a timely response to ensure the
health and well-being of participants, and procedures will be reviewed to determine their
potential contribution to the adverse event. Procedural changes will ensue if they are deemed
to be necessary. These will be done in conjunction with the IRB and guidance from the PI's
research mentors of Dr. Tanya Froehlich (DDBP) or Dr. Rita Pickler (OSU). Both are
experienced as intervention researchers in adverse event monitoring and reporting. At
quarterly meetings with the research mentors, and monthly meetings with the research team,
the PI will review recruitment and data collection to track the meeting of study objectives.
Summary reports of data will be prepared by the PI for review by the research team prior to
each meeting. The mentorship team can request additional information to assist in safety
monitoring. Written minutes of these meetings with summaries of adverse events will be
forwarded to the IRB and NIH as part of the annual reporting process, following institutional
and NIH guidelines. Determinations or recommendations for early stopping of the pilot trial
by the research team (including the research mentors) will be for reasons of safety only.
