TEAMS R34 #3: Team-Based Implementation Strategy for Pediatric Depression Screening

November 3, 2025 updated by: Nicole Stadnick, University of California, San Diego

TEAMS R34 #3: Developing and Testing a Team-Based Implementation Strategy for Depression Screening in a Pediatric Health Care System

Pediatric depression is a global concern that has fueled efforts for enhanced detection and treatment engagement. While many health systems have implemented components of depression screening protocols, there is limited evidence of effective follow-up for pediatric depression. Key barriers to prompt service linkage include a shared understanding of individual and team member roles and coordination between clinicians and staff across service areas. This project aims to refine and test a team-based implementation strategy, a team charter, improve implementation of an existing pediatric depression screening protocol in a large pediatric healthcare system. The implementation strategy will target team mechanisms at the organizational-level and provider-level. The team charter is hypothesized to lead to improved, efficient, and effective decision-making to increase the frequency of depression screening and timely service linkage. Findings are expected to yield better understanding of how to optimize team activities and patterns in the pediatric depression screening to treatment cascade. This should also culminate in improved patient engagement and outcomes, which are critical to address the youth mental health crisis.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Aim 1: Use mixed methods to refine a team-based implementation strategy to improve implementation of an existing health system universal depression screening protocol (clinical intervention)

Aim 2: Use a two-arm hybrid type 3 implementation-effectiveness pilot trial to assess the initial effectiveness of the team-based implementation strategy on the depression screening protocol.

Aim 3: Use mixed methods to assess team/organizational (intra-organizational alignment, implementation climate) and team member/provider (communication, coordination, psychological safety, shared cognitions) mechanisms of the team-based implementation strategy and a novel application of natural language processing methods.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92123
        • UC San Diego: IN STEP Children's Mental Health Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Inclusion criteria for all groups of participants are intentionally broad to ensure valid analyses:

  1. Employed as medical staff and/or a medical or health provider at Rady Children's Hospital San Diego.
  2. Experience providing or supporting care to children and adolescents with mental health care needs.

Exclusion Criteria:

Any individual that does not meet the inclusion criteria will be excluded from study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Condition

In the comparison condition, staff will continue to use multiple discrete strategies already implemented as apart of the depression screening pathway. These existing strategies include:

  1. Training in the depression screening tool (Patient Health Questionnaire)
  2. Orientation to the clinical pathway (i.e., screening conducted at every urgent care or emergency department visit and every 30 days for all other medical visits)
  3. Expectations for handoff to the next step in the care cascade
Providers in the standard condition will be asked to continue practices and response to depression screening as currently implemented by the hospital system.
Experimental: Team-Enhanced Condition

The team-enhanced condition will include:

  1. Two initial 1-hour didactic sessions to develop the team charter.
  2. Biweekly check-ins (15-30 minutes) where the research team will review ongoing use of the team charter with participants and explore any necessary revisions.
Participants in the experimental arm (team-enhanced condition) will be asked to participate in the creation and use of a team charter. This will occur over a period of six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability, Feasibility, and Appropriateness of Intervention Measure
Time Frame: 6 months
This 9-item instrument will be administered to participants following completion of the study intervention. The measure was designed to assess the degree to which the intervention is well-received (acceptability), relevant in the given setting (appropriate), and possible and workable (feasibility). The items on the measure (9 total) are each rated on a scale from 1 (completely disagree) to 5 (completely agree). Following completion, individual subscales (3 total) can be obtained by averaging participants' responses for each of the three components (acceptability, appropriateness, and feasibility).
6 months
Referral Processing Time
Time Frame: 6 months
Referral processing, will be based on the time (in hours) from screening to referral based on electronic health record (EHR) timestamps. This will be used to help assess workflow efficiency.
6 months
Provider Response Based on Patient Health Questionnaire (PHQ-9) Score
Time Frame: Baseline, 3 months, 6 months

This measure will be obtained by using the electronic health record (EHR) to determine whether or not providers responded to a patient with an elevated score (10+) on the Patient Health Questionnaire (PHQ-9). This will help researchers assess clinical outcomes of the study intervention (team communication training).

Context: The Patient Health Questionnaire asks respondents to answer 9 questions that assess mental health status over the patient's last two weeks. Patients answer each question on a scale ranging from 0 (not at all) up to 3 (nearly every day). Scores are calculated by adding individual values together to produce a cumulative score (can range from 0 to 27). A higher score indicates a higher risk for depression symptomology. For the pediatric health system in this study, a score above 10 warrants referral to a behavioral health professional, as well as educational materials and other service referrals.

Baseline, 3 months, 6 months
Mental Health Service Linkage (Caregiver Report of Successful Mental Health Service Linkage)
Time Frame: 3 months, 6 months

Successful mental health service linkage will be assessed by obtaining caregivers' reports of linkage to any mental health service (internal and external of study's chosen pediatric healthy system) following an elevated depression score on the PHQ-9 (10+).

Context: The Patient Health Questionnaire asks respondents to answer 9 questions that assess mental health status over the patient's last two weeks. Patients answer each question on a scale ranging from 0 (not at all) up to 3 (nearly every day). Scores are calculated by adding individual values together to produce a cumulative score (can range from 0 to 27). A higher score indicates a higher risk for depression symptomology. For the pediatric health system in this study, a score above 10 warrants referral to a behavioral health professional, as well as educational materials and other service referrals.

3 months, 6 months
Referral Quality (Provider Report of Successful Mental Health Service Referrals)
Time Frame: 6 months
Referral quality is a measure based on providers' reports of whether referral to the a behavioral health service occurred or not. This will be used to assess workflow efficiency.
6 months
Time to Mental Health Service Linkage
Time Frame: Baseline, 3 months, 6 months

This measure captures time (days) to service linkage for patients that need referrals based on the Patient Health Questionnaire (PHQ-9) score. This data will be obtained from the electronic health record (EHR). This will help researchers assess clinical outcomes of the study intervention (team communication training).

Context: The Patient Health Questionnaire asks respondents to answer 9 questions that assess mental health status over the patient's last two weeks. Patients answer each question on a scale ranging from 0 (not at all) up to 3 (nearly every day). Scores are calculated by adding individual values together to produce a cumulative score (can range from 0 to 27). A higher score indicates a higher risk for depression symptomology. For the pediatric health system in this study, a score above 10 warrants referral to a behavioral health professional, as well as educational materials and other service referrals.

Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation Climate Measure
Time Frame: Baseline, 3 months, 6 months
Implementation climate will be measured with the Implementation Climate Measure. Implementation climate refers to the belief amongst users of an innovation within an organization that utilizing said innovation is rewarded, supported and expected. This instrument consists of 6 items that assess implementation with two questions per climate dimension (expected, supported, and rewarded). The instrument is based on a Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Scores are averaged across multiple items to give an overall score or subscale score for implementation climate. Generally, a higher score indicates a more positive perception of implementation climate in an organization. This instrument will be administered to participants through study completion.
Baseline, 3 months, 6 months
Collaboration and Satisfaction About Care Decisions (CSACD)
Time Frame: Baseline, 3 months, 6 months
The CSACD instrument (6 items total) will be used to assess communication and coordination. For each question, participants respond based on a 7-point likert-type scale where 1= strongly disagree and 7 = strongly agree. 2 individual subscales (3 questions each) can be obtained by averaging responses for the items related to collaboration and the items related to satisfaction.
Baseline, 3 months, 6 months
Edmonson's Psychological Safety (Interpersonal Risk Taking) Climate Measure
Time Frame: Baseline, 3 months, 6 months
Psychological safety, which refers to an individual's understanding that the workplace, (specifically the policies/procedures) cultivates a safe arena for interpersonal risk taking, will be measured using Edmonson's Psychological Safety Climate Measure. Participants respond to 7 items total with answer choices from 0 (doesn't apply at all) up to 4 (entirely applies). Scale scores are then determined by averaging responses to each item. Generally, a higher score indicates a stronger perception of psychological safety within the team.
Baseline, 3 months, 6 months
Family Demographics Questionnaire
Time Frame: Baseline, 3 months, 6 months
Child demographics will be obtained using a Family Demographics Questionnaire and the electronic health record (EHR).
Baseline, 3 months, 6 months
Card Sorting Activity
Time Frame: Baseline, 3 months, 6 months

Card sorting is a research assessment to elicit individual mental models about a participant's understanding of a situation, event, or process. Within team contexts, card sorting can be used to interrogate the extent to which team members have aligned thinking about key elements of a situation, event or process, i.e., team mental models.

In open card sorts participants are given a set of main concepts and told to sort them into different categories. Each makes a specific label for each category. In closed card sorts, participants are also given a set of key concepts, but participants are instead given pre-existing categories to sort concepts into. Each participant from the Aim 2 trial will complete the card-sorting task following team charter development to assess team mental models of member roles, responsibilities, and goals across depression care cascade team members.

Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nicole A Stadnick, PhD, MPH, UCSD Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 810627
  • P50MH126231 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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