Process Mapping to Optimize Child Psychosocial Screenings in Primary Care, and Increase Family Service Linkages

Enrolling by invitation · Not applicable

Conditions studied: Mental Health Care

In brief

Many families screened in primary care for social challenges to identify psychosocial needs of caregivers and children do not receive the follow-up support they need. This study will test a new clinic-based approach, CARELOOP, designed to improve how families are referred to and connected with services. Using community input and a method called Process Service Mapping, the project will tailor clinic workflows and evaluate the approach's impact through a randomized trial. The goal is to improve care coordination and reduce health disparities.

Key facts

Study ID

NCT06989476

Run by

University of Colorado, Denver

People needed

330

Starts

2026-02-17

Expected to finish

2029-07-31

Last updated by the study team

2025-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Caregiver of child is 18 years or older with legal custody or authority to arrange care for child ages 0-5 years old.
• Caregiver provides informed consent
• Caregiver provides permission for socio-demographic information about their child to be pulled from EMR records, de-identified, and shared with PI

You may not qualify if…

• Caregiver declines to provide signed informed consent, HIPAA release, or permission for socio-demographic data to be pulled from the Electronic Medical Records (EMR), de-identified and shared with PI;
• Children ages 6-18 scheduled for wellness visits
• Children ages 0-5 scheduled for wellness visits outside the study data collection windows or at clinics not providing pediatric care
• Caregiver does not have legal guardianship or written authority to arrange care for the child

Where it is running

• Denver Health — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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