CARELOOP for Mental Health

(CARELOOP Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Consent, Hipaa release, Guardianship, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the connection of families to support services after screening for social challenges in primary care. It tests a new approach called CARELOOP, which improves how clinics refer families to necessary services. The trial includes two groups: one using the CARELOOP system and the other following standard care procedures. Caregivers legally responsible for children aged 0 to 5 who are willing to provide basic information may be suitable for this trial. As an unphased trial, this study offers families a unique opportunity to contribute to innovative solutions in healthcare support systems.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving care coordination for families, so it's best to ask the trial organizers for more details.

What prior data suggests that the CARELOOP intervention is safe for improving care coordination?

Research shows that the CARELOOP program aims to improve mental health care by helping families access necessary services. Although specific safety data for CARELOOP in this trial is unavailable, it is built on a platform already used in mental health care. Researchers and doctors have tested and approved this platform, demonstrating its safety and effectiveness in addressing mental health issues.

The program's goal is to help clinics support families better by using community feedback and customized plans. While specific safety data for this trial is lacking, CARELOOP's established use in mental health care suggests it is well-received and aims to prevent problems before they occur. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARELOOP intervention because it offers a fresh approach to supporting young children's mental health by integrating screening and support services in a streamlined manner. Unlike standard care, which typically involves separate screenings and referrals, CARELOOP seamlessly connects clinics to identify psychological concerns in children ages 0 to 5 and directly links them and their caregivers to necessary support services. This integrated approach is designed to provide faster and potentially more effective support for mental health needs by reducing delays in referrals and increasing accessibility to care.

What evidence suggests that the CARELOOP intervention is effective for improving care coordination in mental health?

Research has shown that the CARELOOP program effectively helps people with severe mental illness. Five studies have demonstrated its success in connecting patients with necessary support. In this trial, participants in the CARELOOP Intervention Group will experience this program, which has reduced the chances of psychosis relapse by 50%, significantly improving the quality of care and patient outcomes. By using AI (artificial intelligence), CARELOOP makes the support process more efficient and personalized. This approach enhances health care coordination and promotes fairness by addressing disparities in access to mental health services. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for families with children who have been screened in primary care for social challenges. It aims to help caregivers and their kids get better follow-up support. The study seeks participants willing to try a new approach called CARELOOP, which may improve service referrals and connections.

Inclusion Criteria

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

I am over 18 and legally responsible for a child aged 0-5.

Exclusion Criteria

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

My child, aged 6-18, is scheduled for a wellness visit.

Caregiver does not have legal guardianship or written authority to arrange care for the child

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of the CARELOOP intervention to optimize service pathways and increase family referral and linkage follow-up

2 years

Follow-up

Participants are monitored for effectiveness of service referrals and linkages

2 years

What Are the Treatments Tested in This Trial?

Interventions

• CARELOOP Intervention

Trial Overview The CARELOOP intervention is being tested to see if it can enhance the way clinics refer families to services after identifying psychosocial needs. This randomized trial will assess whether tailored clinic workflows can boost care coordination and tackle health disparities.

How Is the Trial Designed?

Group I: CARELOOP Intervention Group Experimental Treatment 1 Intervention

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

Group II: Standard Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Denver Health and Hospital Authority

Collaborator

Trials

106

Recruited

403,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Citations

1. careloop.health careloop.health/evidence/

Evidence ... effective at improving outcomes for people living with and at risk of severe mental illness. To date, five randomised controlled trials have validated the ...

2. careloop.health careloop.health/professionals/

Professionals Reduce psychosis relapse events by 50%, significantly improving quality of care and patient outcomes. Supporting health equity and sustainability +. Support ...

3. careloop.health careloop.health/2025/06/25/how-ai-is-shaping-the-management-of-severe-mental-illness/

How AI is shaping the management of severe mental illness At CareLoop Health, we're already using AI to power our platform in simple ways, and we're undertaking significant research to develop more ...

4. isrctn.com isrctn.com/pdf/88145142

Feasibility trial of ClinTouch-CareLoop Enhanced ... They will receive CareLoop enhanced support and management from mental health staff who have access to symptom information and EWS alerts ...

5. humanfactors.jmir.org humanfactors.jmir.org/2024/1/e53406/PDF

A Qualitative Study Among Mental Health Care Professionals Background: Given the physical health disparities associated with mental illness, targeted lifestyle interventions are required.

6. careloop.health careloop.health/help/

Help - Center Access comprehensive training materials to help you better support people living with psychosis using CareLoop. Our training modules cover everything from basic ...

7. healthinnovationsouthwest.com healthinnovationsouthwest.com/programmes/careloop/

CareLoop: Severe Mental Illness Staff: Real-time data and insights on symptoms help healthcare professionals identify early warning signs, improve clinical decision-making and prevent ...