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

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06989476
Status
Enrolling By Invitation

Conditions

  • Mental Health Care

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CARELOOP Intervention — OTHER
    CARELOOP Intervention (Clinics cAtch needs, REfer, Link to services, and close the lOOp using an equitable family-centered Process). CARELOOP is a way of enhancing psychosocial screenings through PSM methodology and Implementation Science, and grounded in the Clinical-Community Relationships Evaluation framework

Study Details

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 Dates

Start date
Feb 17, 2026
Status verified
Apr 2025
Primary completion
Dec 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: CARELOOP Intervention Group
    Clinics using the CARELOOP intervention to screen children ages 0 to 5 and link children and their caregivers to support services
  • No Intervention: Standard Care
    Clinics screening children ages 0-5 years to identify psychosocial and activate referrals per standard care

Primary Outcome Measure

Service referral [ Time Frame: Through study data collection completion, an average of 2 years; years two through four of the project. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Denver HealthDenverColorado80204-

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