Mental Health CareCARELOOPNCT06989476
Process Mapping to Optimize Child Psychosocial Screenings in Primary Care, and Increase Family Service Linkages
A study testing CARELOOP Intervention in people with Mental Health Care, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Care
- What is being tested?
- CARELOOP Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Using Process Mapping to Optimize the Integration of Child Psychosocial Screenings in Primary Care, Promote Whole-person Care, and Increase Family Linkages to Behavioral and Safety Net Services
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.
Read the detailed description
Despite an increased health systems investment in primary care screenings to identify the psychosocial needs of caregivers and children (e.g., exposure to violence, racism, and insecure housing), these efforts don't always result in family-centered service referrals and follow-up to ensure all needs are getting met (i.e., families able to access services such as housing and behavioral health support). When psychosocial needs aren't identified or addressed during childhood, it can cause or worsen children's health conditions, interrupt their development, and, at the societal level, perpetuate disparities in overall health. The investigators' preliminary data identified key strengths and weaknesses within families' journeys through psychosocial screenings, service referral and linkage processes in primary care - which the investigators term "service pathways". The goal of the current study is to optimize the post-screening pathway to increase family referral and linkage follow-up, so that all screened families receive consistent services. The investigators hypothesis is that clinics using the proposed adaptive intervention package will increase family referral and linkage follow-up compared to clinics using current screening practices. A novel and replicable approach to optimize service pathways that include these family-centered elements and implementation strategies is Process Service Mapping (PSM). PSM is an iterative approach to mapping patients' pathways to identify inequities, challenges, and action points. This study seeks to scale up previous work by testing the CARELOOP Intervention (Clinics cAtch needs, REfer, Link to services, and close the lOOp using an equitable family-centered Process). CARELOOP is a system-level intervention that will tailor primary care workflows with PSM-informed decision rules, procedural steps, and implementation strategies with input from clinics and communities. Denver Health is an optimal partner as they are a large safety net system serving minoritized families and 11 pediatric clinics already screen for psychosocial needs using the Health-Related Social Needs and Survey of Well-being of Young Children. The investigators' main hypothesis is that intervention clinics will have higher Service Referrals and Linkages compared to standard care control clinics. After optimizing service pathways (Aim 1), the investigators will conduct a cluster-randomized trial to test the impact of CARELOOP on effectiveness (Aim 2) and implementation outcomes (Aim 3). The study goals are: Aim 1: Engage clinics and communities to refine the CARELOOP intervention by mapping service pathways to include equity and family-centered elements and tailored strategies; Aim 2: Use a parallel-arm cluster randomized trial to test the effectiveness of the CARELOOP intervention; and Aim 3: Conduct an implementation evaluation of the CARELOOP intervention. This R01 study leverages current psychosocial screening practices to rigorously test an intervention designed to increase service referrals and linkages. The investigators bring quality improvement, implementation science, and a novel co-creation engagement approach to accelerate family-centered care
- Conditions
- Mental Health Care
- Being tested
- CARELOOP Intervention
- Keywords
- mental health, pyschosocial needs, service linkage, service mapping, primary care
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARELOOP InterventionOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: CARELOOP Intervention |
| Standard Care | No intervention | Clinics screening children ages 0-5 years to identify psychosocial and activate referrals per standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Through study data collection completion, an average of 2 years; years two through four of the project.
Secondary outcomes (1)
Referral-to-linkage time
Number of days and based on date of referral after screenings (EHR data at the clinic) and date of referral reported by partner Community Based Organizations
Measured: Through study data collection completion, an average of 2 years; years two through four of the project.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start17 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health CareStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health and Hospital Authority, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989476
- Sponsor's protocol ID
- 24-1929
- Other IDs
- 1R01HS029858-01A1
- Acronym
- CARELOOP
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Process Mapping to Optimize the Integration of Child Psychosocial Screenings in Primary Care, Promote Whole-person Care, and Increase Family Linkages to Behavioral and Safety Net Services
- ClinicalTrials.gov ID
- NCT06989476
- Acronym / sponsor ID
- CARELOOP / 24-1929
- Conditions
- Mental Health Care
- Keywords
- mental health, pyschosocial needs, service linkage, service mapping, primary care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Denver Health and Hospital Authority, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 17 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite an increased health systems investment in primary care screenings to identify the psychosocial needs of caregivers and children (e.g., exposure to violence, racism, and insecure housing), these efforts don't always result in family-centered service referrals and follow-up to ensure all needs are getting met (i.e., families able to access services such as housing and behavioral health support). When psychosocial needs aren't identified or addressed during childhood, it can cause or worsen children's health conditions, interrupt their development, and, at the societal level, perpetuate disparities in overall health. The investigators' preliminary data identified key strengths and weaknesses within families' journeys through psychosocial screenings, service referral and linkage processes in primary care - which the investigators term "service pathways". The goal of the current study is to optimize the post-screening pathway to increase family referral and linkage follow-up, so that all screened families receive consistent services. The investigators hypothesis is that clinics using the proposed adaptive intervention package will increase family referral and linkage follow-up compared to clinics using current screening practices. A novel and replicable approach to optimize service pathways that include these family-centered elements and implementation strategies is Process Service Mapping (PSM). PSM is an iterative approach to mapping patients' pathways to identify inequities, challenges, and action points. This study seeks to scale up previous work by testing the CARELOOP Intervention (Clinics cAtch needs, REfer, Link to services, and close the lOOp using an equitable family-centered Process). CARELOOP is a system-level intervention that will tailor primary care workflows with PSM-informed decision rules, procedural steps, and implementation strategies with input from clinics and communities. Denver Health is an optimal partner as they are a large safety net system serving minoritized families and 11 pediatric clinics already screen for psychosocial needs using the Health-Related Social Needs and Survey of Well-being of Young Children. The investigators' main hypothesis is that intervention clinics will have higher Service Referrals and Linkages compared to standard care control clinics. After optimizing service pathways (Aim 1), the investigators will conduct a cluster-randomized trial to test the impact of CARELOOP on effectiveness (Aim 2) and implementation outcomes (Aim 3). The study goals are: Aim 1: Engage clinics and communities to refine the CARELOOP intervention by mapping service pathways to include equity and family-centered elements and tailored strategies; Aim 2: Use a parallel-arm cluster randomized trial to test the effectiveness of the CARELOOP intervention; and Aim 3: Conduct an implementation evaluation of the CARELOOP intervention. This R01 study leverages current psychosocial screening practices to rigorously test an intervention designed to increase service referrals and linkages. The investigators bring quality improvement, implementation science, and a novel co-creation engagement approach to accelerate family-centered care
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| CARELOOP Intervention Group | Experimental | Other: CARELOOP InterventionClinics using the CARELOOP intervention to screen children ages 0 to 5 and link children and their caregivers to support services |
| Standard Care | No intervention | –Clinics screening children ages 0-5 years to identify psychosocial and activate referrals per standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARELOOP InterventionCARELOOP 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 | Other | CARELOOP Intervention Group |
Primary outcome
Service referral
Time frame: Through study data collection completion, an average of 2 years; years two through four of the project.
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).
Service linkage
Time frame: Through study data collection completion, an average of 2 years; years two through four of the project.
Caregiver made contact with the referred service
1 secondary outcome
Referral-to-linkage time
Time frame: Through study data collection completion, an average of 2 years; years two through four of the project.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARELOOP Intervention in people with Mental Health Care, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Service referral (time frame: Through study data collection completion, an average of 2 years; years two through four of the project.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.