NCT01264718

Brief Summary

The Kids' HELP trial rigorously documented that a Parent Mentor intervention results in multiple benefits: more children are insured faster, children's access to healthcare and parental satisfaction improve, quality of well-child care is enhanced, thousands of dollars are saved per child, jobs are created, disparities are eliminated, and the intervention potentially could save our nation billions of dollars.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 19, 2019

Completed
Last Updated

April 19, 2019

Status Verified

January 1, 2019

Enrollment Period

5.5 years

First QC Date

December 20, 2010

Results QC Date

March 14, 2017

Last Update Submit

January 18, 2019

Conditions

Keywords

minority healthchildMedicaid

Outcome Measures

Primary Outcomes (1)

  • Number of Children With Health Insurance

    A study child is considered insured once official written notification of insurance is confirmed, either through an electronic or hard copy of the state coverage letter, or via verification from the Texas Health and Human Services Center.

    One year after enrollment

Secondary Outcomes (3)

  • Number of Days From Study Enrollment to Obtaining Coverage

    One year after enrollment

  • Parental Satisfaction With the Process of Obtaining Coverage for Child

    One year after enrollment

  • Intervention Cost-Effectiveness Ratio (ICER)

    One year after enrollment

Study Arms (2)

Control

NO INTERVENTION

After randomization to the control group, minority low-income parents of uninsured, Medicaid/CHIP-eligible children received only traditional Medicaid/Children's Health Insurance Program (CHIP) outreach and enrollment.

Parent Mentors

EXPERIMENTAL

After randomization to the Parent Mentor group, minority low-income parents of uninsured Medicaid/CHIP-eligible children received face-to-face instruction and guidance from Parent Mentors on obtaining and keeping Medicaid/CHIP for their child; getting a doctor, dentist, and pharmacist; and addressing social determinants of health.

Behavioral: Parent Mentors

Interventions

Parent MentorsBEHAVIORAL

After random assignment to the Parent Mentor group, minority low-income parents of Medicaid/CHIP eligible children met with Parent Mentors to receive instruction and help on completing, submitting applications for, and maintaining Medicaid/CHIP coverage for their child.

Also known as: Kids' HELP
Parent Mentors

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The parent/guardian is a primary caretaker of a least one child 0-18 years old who currently has no health insurance
  • The parent/guardian self-identifies the uninsured child as Hispanic/Latino, African-American/Black, or both
  • The uninsured child is eligible for either Medicaid or CHIP
  • The parent/guardian is willing to be contacted monthly by telephone, or in the form of a home visit (if no functioning telephone is present in the household).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (5)

  • Flores G, Walker C, Lin H, Lee M, Fierro M, Henry M, Massey K, Portillo A. Design, methods, and baseline characteristics of the Kids' Health Insurance by Educating Lots of Parents (Kids' HELP) trial: a randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children. Contemp Clin Trials. 2015 Jan;40:124-37. doi: 10.1016/j.cct.2014.11.015. Epub 2014 Dec 2.

    PMID: 25476583BACKGROUND
  • Flores G, Walker C, Lin H, Lee M, Fierro M, Henry M, Massey K, Portillo A. A successful program for training parent mentors to provide assistance with obtaining health insurance for uninsured children. Acad Pediatr. 2015 May-Jun;15(3):275-81. doi: 10.1016/j.acap.2014.09.011. Epub 2014 Dec 1.

    PMID: 25447369BACKGROUND
  • Flores G, Lin H, Walker C, Lee M, Currie JM, Allgeyer R, Fierro M, Henry M, Portillo A, Massey K. Parent Mentors and Insuring Uninsured Children: A Randomized Controlled Trial. Pediatrics. 2016 Apr;137(4):e20153519. doi: 10.1542/peds.2015-3519. Epub 2016 Mar 17.

    PMID: 27244706BACKGROUND
  • Flores G, Lin H, Walker C, Lee M, Portillo A, Henry M, Fierro M, Massey K. A cross-sectional study of parental awareness of and reasons for lack of health insurance among minority children, and the impact on health, access to care, and unmet needs. Int J Equity Health. 2016 Mar 22;15:44. doi: 10.1186/s12939-016-0331-y.

    PMID: 27000795BACKGROUND
  • Flores G, Portillo A, Lin H, Walker C, Fierro M, Henry M, Massey K. A successful approach to minimizing attrition in racial/ethnic minority, low-income populations. Contemp Clin Trials Commun. 2017 Mar;5:168-174. doi: 10.1016/j.conctc.2017.01.009. Epub 2017 Feb 14.

    PMID: 28378019BACKGROUND

Related Links

Results Point of Contact

Title
Dr. Glenn Flores, Distinguished Chair of Health Policy Research
Organization
Medica Research Institute

Study Officials

  • Glenn Flores, M.D.

    Connecticut Children's Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief Research Officer, and Associate Chair of Research

Study Record Dates

First Submitted

December 20, 2010

First Posted

December 22, 2010

Study Start

December 1, 2010

Primary Completion

May 31, 2016

Study Completion

May 31, 2016

Last Updated

April 19, 2019

Results First Posted

April 19, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations