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

NCT06989476 | Enrolling By Invitation

• 2 other identifiers: 24-19291R01HS029858-01A1
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health Care

Keywords

mental health; pyschosocial needs; service linkage; service mapping; primary care

Outcome Measures

Primary Outcomes (2)

• Service referral

  Number of service referrals / Total number of positive screenings (i.e., caregiver reported a need and accepts outreach for a service referral by clinic navigator).

  Through study data collection completion, an average of 2 years; years two through four of the project.

• Service linkage

  Caregiver made contact with the referred service

  Through study data collection completion, an average of 2 years; years two through four of the project.

Secondary Outcomes (1)

• Referral-to-linkage time

  Through study data collection completion, an average of 2 years; years two through four of the project.

Study Arms (2)

CARELOOP Intervention Group

EXPERIMENTAL

Clinics using the CARELOOP intervention to screen children ages 0 to 5 and link children and their caregivers to support services

Other: CARELOOP Intervention

Standard Care

NO INTERVENTION

Clinics screening children ages 0-5 years to identify psychosocial and activate referrals per standard care

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

CARELOOP Intervention Group

Eligibility Criteria

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

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Denver Health and Hospital Authority: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

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: a parallel-arm cluster randomized trial to test the effectiveness of the CARELOOP intervention. Study clinics (11 clusters) will be randomly assigned: 5 clinics will screen children ages 0-5 years and activate referrals per standard care (Control group), and 6 clinics will use Standard Care plus the CARELOOP intervention (Intervention group).

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 25, 2025
• Study Start: February 17, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: May 25, 2025

Record last verified: 2025-04

Locations

US (1)