DepressionNCT06527196
TEAMS R34 #3: Team-Based Implementation Strategy for Pediatric Depression Screening
A study testing Team-Enhanced Condition and Standard Condition in people with Depression and Children, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Children
- What is being tested?
- Team-Enhanced Condition and Standard Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 31 Jan 2027
- 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
- Inclusion criteria for all groups of participants are intentionally broad to ensure valid analyses:
- 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.
Who cannot join
- Any individual that does not meet the inclusion criteria will be excluded from study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego: IN STEP Children's Mental Health Research Center
San Diego, California, 92123
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Children
- Being tested
- Team-Enhanced Condition, Standard Condition
- Keywords
- Depression Screening, Team Charter, Team Effectiveness
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-Enhanced ConditionBehavioural
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.
Standard ConditionBehavioural
Providers in the standard condition will be asked to continue practices and response to depression screening as currently implemented by the hospital system.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Team-Enhanced Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (5)
Implementation Climate Measure
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.
Measured: Baseline, 3 months, 6 months
Collaboration and Satisfaction About Care Decisions (CSACD)
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.
Measured: Baseline, 3 months, 6 months
Card Sorting Activity
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.
Measured: Baseline, 3 months, 6 months
Edmonson's Psychological Safety (Interpersonal Risk Taking) Climate Measure
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.
Measured: Baseline, 3 months, 6 months
Family Demographics Questionnaire
Child demographics will be obtained using a Family Demographics Questionnaire and the electronic health record (EHR).
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Jun 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nicole Stadnick, University of California, San Diego
- Investigators
- Nicole A Stadnick, PhD, MPH, Principal investigator, UCSD Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527196
- Sponsor's protocol ID
- 810627
- Other IDs
- P50MH126231
- Status last verified
- Nov 2025
- First submitted
- 19 Jul 2024
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39425229
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEAMS R34 #3: Developing and Testing a Team-Based Implementation Strategy for Depression Screening in a Pediatric Health Care System
- ClinicalTrials.gov ID
- NCT06527196
- Acronym / sponsor ID
- 810627
- Conditions
- Depression, Children
- Keywords
- Depression Screening, Team Charter, Team Effectiveness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 30 Jul 2024 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Condition | Active comparator | Behavioral: Standard ConditionIn 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 |
| Team-Enhanced Condition | Experimental | Behavioral: Team-Enhanced ConditionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inclusion criteria for all groups of participants are intentionally broad to ensure valid analyses:
- 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.
Key exclusion criteria (1 listed)
- Any individual that does not meet the inclusion criteria will be excluded from study participation.
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 |
|---|---|---|
| Team-Enhanced ConditionParticipants 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. | Behavioural | Team-Enhanced Condition |
| Standard ConditionProviders in the standard condition will be asked to continue practices and response to depression screening as currently implemented by the hospital system. | Behavioural | Standard Condition |
Primary outcome
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).
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.
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.
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.
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.
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.
5 secondary outcomes
Implementation Climate Measure
Time frame: Baseline, 3 months, 6 months
Collaboration and Satisfaction About Care Decisions (CSACD)
Time frame: Baseline, 3 months, 6 months
Card Sorting Activity
Time frame: Baseline, 3 months, 6 months
Edmonson's Psychological Safety (Interpersonal Risk Taking) Climate Measure
Time frame: Baseline, 3 months, 6 months
Family Demographics Questionnaire
Time frame: Baseline, 3 months, 6 months
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 5 Nov 2025.
- Derived from this study: PubMed 39425229Stadnick 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.
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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. This study is not recruiting at the moment.
Nicole A Stadnick, PhD, MPH principal investigator
UCSD Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team-Enhanced Condition and Standard Condition in people with Depression and Children, run by University of California, San Diego 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 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 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?
Acceptability, Feasibility, and Appropriateness of Intervention Measure (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06527196, which also lists 1 linked publication.
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 5 Nov 2025.