Head Start Family Navigator Intervention

NCT03499405 | Completed DMC

• 1 other identifier: CIN001-HeadStart Navigator Int
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Developmental Delay

Keywords

development and health disparities and navigation

Outcome Measures

Primary Outcomes (1)

• Proportion of children who complete developmental testing guided by family navigators (feasibility).

  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).

  Up to three months.

Secondary Outcomes (6)

• Caregiver satisfaction with the intervention and implementation

  Up to two months.

• Family Navigator satisfaction with the intervention and implementation

  Up to two months.

• Teacher satisfaction with the intervention and implementation

  Up to two months.

• Primary Care Provider satisfaction with the intervention and implementation

  Up to two months.

• Caregiver Knowledge of child developmental disparities (health promotion).

  Up to two months.

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group will receive a family navigator intervention from a culturally matched family navigator.

Behavioral: Family Navigator Intervention

Control group

NO INTERVENTION

Control group will not receive a family navigator intervention from a culturally matched family navigator.

Interventions

Family Navigator Intervention BEHAVIORAL

Caregivers will be paired with a culturally matched family navigator.

Intervention group

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• FN participants will be current or former HS parents and sampled from urban and suburban HS.Eight FNs will be trained to support and guide caregivers through developmental testing, including 4 African American, 2 Caucasian and 2 bi-lingual Hispanic parents. Each FN will be assigned 1 to 4 caregivers.
• The study sample of caregiver participants will include 32 eligible HS caregivers of preschoolers between 3 and 4 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.24,25 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.

You may not qualify if:

• For FN, not being a former head start parent.
• For caregiver, child not failing more than 2 or more domains on developmental testing.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Office of Head Start: collaborator

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Smith T, Burkett K, Pickler R, Bowers K, Weber S, Trenkamp E, Heeman A, Stanton-Chapman T, Copeland K, Froehlich T. Feasibility, Acceptability, and Preliminary Effectiveness of Family Navigation for Low-income Ethnoracially Diverse Preschoolers with Developmental Concern. J Racial Ethn Health Disparities. 2025 Sep 16. doi: 10.1007/s40615-025-02556-w. Online ahead of print.

  PMID: 40956380 DERIVED

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group will have access to a culturally matched family navigator, control group will not have access to a culturally matched family navigator.

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: April 17, 2018
• Study Start: August 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)