NCT06527196

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable depression

Timeline
8mo left

Started Jun 2024

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jun 2024Jan 2027

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

July 19, 2024

Last Update Submit

November 3, 2025

Conditions

Keywords

Depression ScreeningTeam CharterTeam Effectiveness

Outcome Measures

Primary Outcomes (6)

  • Acceptability, Feasibility, and Appropriateness of Intervention Measure

    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

    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

    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)

    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)

    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

    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 Outcomes (5)

  • Implementation Climate Measure

    Baseline, 3 months, 6 months

  • Collaboration and Satisfaction About Care Decisions (CSACD)

    Baseline, 3 months, 6 months

  • Card Sorting Activity

    Baseline, 3 months, 6 months

  • Edmonson's Psychological Safety (Interpersonal Risk Taking) Climate Measure

    Baseline, 3 months, 6 months

  • Family Demographics Questionnaire

    Baseline, 3 months, 6 months

Study Arms (2)

Standard Condition

ACTIVE COMPARATOR

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

Behavioral: Standard Condition

Team-Enhanced Condition

EXPERIMENTAL

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.

Behavioral: Team-Enhanced Condition

Interventions

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.

Team-Enhanced Condition

Providers in the standard condition will be asked to continue practices and response to depression screening as currently implemented by the hospital system.

Standard Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego: IN STEP Children's Mental Health Research Center

San Diego, California, 92123, United States

Location

Related Publications (1)

  • Stadnick NA, Aarons GA, Edwards HN, Bryl AW, Kuelbs CL, Helm JL, Brookman-Frazee L. Cluster randomized trial of a team communication training implementation strategy for depression screening in a pediatric healthcare system: a study protocol. Implement Sci Commun. 2024 Oct 18;5(1):117. doi: 10.1186/s43058-024-00641-5.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Nicole A Stadnick, PhD, MPH

    UCSD Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 30, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

November 5, 2025

Record last verified: 2025-11

Locations