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Study objectives are to design and pilot test a novel, exposure-based implementation strategy (EBIS) directly targeting clinician anxiety and low self-efficacy for use of evidence-based suicide screening, assessment, and intervention (SSAI) strategies with patients at risk for suicide in community settings. Early phases of this study will develop the EBIS in partnership with community clinicians (n = 15). The last phase of this study is a pilot clinical trial in which 40 community mental health clinicians will be randomized to receive either implementation as usual (IAU) or IAU+EBIS.
This exploratory project brings together an interdisciplinary team to design and pilot-test an exposure-based implementation strategy (EBIS) to target clinician-level anxiety about suicide screening, assessment, and intervention (SSAI) use. We will test the effect of EBIS as an implementation strategy to augment Implementation as Usual (IAU) to enhance SSAI implementation in community mental health settings. Specifically, this study first will use participatory design methods to develop and refine EBIS in collaboration with a stakeholder advisory board of clinicians, administrators, and content experts. This study then will further iteratively refine EBIS with up to 15 clinicians in a pilot field test, using rapid cycle prototyping, in collaboration with the INSPIRE Methods Core. Clinicians in Aim 2 will also provide qualitative feedback on EBIS' ability to mitigate anxiety and increase self-efficacy to deliver SSAIs to optimize our ability to engage target mechanisms of clinician anxiety. In the final phase, this study will test the refined EBIS in a pilot implementation trial in which 40 community mental health clinicians will be randomized to receive either IAU or EBIS+IAU. Primary clinical trial dependent variables are EBIS acceptability and feasibility, measured through questionnaires, interviews, and recruitment and retention statistics; this pilot trial is not intended to be powered to detect effects. Secondary outcomes are preliminary effectiveness of EBIS on clinician-level implementation outcomes (SSAI adoption), and engagement of target implementation mechanisms (clinician anxiety and self-efficacy related to SSAI use), assessed via mixed methods.
Aim 1 did not include data collection from study participants. Activities in this aim only included refinement with the advisory board members who were not considered study participants.
Data collected in Aim 2 was largely descriptive and qualitative to inform EBIS development and refinement activities.
We are reporting Aim 3 data which included pilot randomization with clinicians. Data was collected at the following timepoints: Time 1: baseline measures completed before the training; Time 2: immediately after completing the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure Based Implementation Strategy (EBIS) | Experimental | EBIS is informed by the latest science in exposure theory, borrowing heavily from brief exposure-based treatments that can be delivered in a single session. We anticipate that EBIS will occur in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention; however, the final version will depend on the outcomes of the preparatory phases of this study. Clinicians assigned to the EBIS arm will also receive all elements of IAU. |
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| Implementation as Usual (IAU) | Active Comparator | Gold-standard IAU for SSAIs typically comprises pre-implementation preparation, didactic training, knowledge tests, experiential role plays, ongoing expert consultation, and providing certification status to clinicians who attain established benchmarks. Pre-implementation preparation will include provision of materials. Didactic training will occur in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one will consist of materials we previously developed based on community clinician feedback. Part two will follow established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also will include supports for electronic health record integration (e.g., previously developed templates). After training, clinicians will receive 8 weeks of expert consultation to discuss implementation barriers and receive more role play practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure Based Implementation Strategy (EBIS) | Behavioral | EBIS will include psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Perception of EBIS Acceptability for Clinical Practice at Time 4, 12 Weeks After Completing Training | Acceptability of EBIS was measured with the Acceptability of Intervention Measure (AIM), a 4-item, psychometrically-validated measure that indexes the extent to which stakeholders believe an implementation strategy is acceptable. Items on the AIM are rated on a 5-point Likert scale (Range = 4-20) and higher scores indicate greater acceptability. | Time 4: 12 weeks after completing training |
| Clinician Perception of EBIS Feasibility and Utility for Clinical Practice at Time 4, 12 Weeks After Completing Training | Feasibility of EBIS was measured with the Feasibility of Intervention Measure (FIM), a 4-item measure that indexes the extent to which an implementation strategy is perceived as feasible. Items on the FIM are rated on a 5-point Likert scale (Range = 4-20) and higher scores indicate greater acceptability. | Time 4: 12 weeks after completing training |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Anxiety at 4 Timepoints Across 12 Weeks | Clinician anxiety was assessed via 10-point Subjective Units of Distress (SUDS), a 10-point Likert rating of subjective distress where 1 = Not at all Distressed and 10 = Very Distressed. Clinicians rated their anxiety on screening and safety planning separately. | Time 1: baseline measures completed before the training; Time 2: immediately after completing the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Department of Psychiatry | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38001478 | Background | Becker-Haimes EM, Brady M, Jamison J, Jager-Hyman S, Reilly ME, Patel E, Brown GK, Mandell DS, Oquendo MA. An exposure-based implementation strategy to decrease clinician anxiety about implementing suicide prevention evidence-based practices: protocol for development and pilot testing (Project CALMER). Implement Sci Commun. 2023 Nov 24;4(1):148. doi: 10.1186/s43058-023-00530-3. |
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42 participants were consented into the study. 3 dropped out before completing any study activities due to time constraints or a change in eligibility status. 39 completed baseline measures before randomization (time 1). Of the 39, 3 dropped out due to timing constraints or change in eligibility status. 36 were randomized to condition by training type.
We are reporting Aim 3 data which included pilot randomization with clinicians. Data from Aims 1 and 2 are not included as these aims were largely preparatory. Aim 3 data was collected at baseline before the training (Time 1), after the training (Time 2), two weeks after the training (Time 3), and 12 weeks after the training (Time 4). These clinician participants were recruited from 5 agencies between July to August 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exposure Based Implementation Strategy (EBIS) | EBIS is informed by the latest science in exposure theory, borrowing heavily from brief exposure-based treatments that can be delivered in a single session. EBIS occurred in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention. Clinicians assigned to the EBIS arm received all elements of the EBIS plus all elements of IAU. Exposure Based Implementation Strategy (EBIS): EBIS included psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice. |
| FG001 | Implementation as Usual (IAU) | Gold-standard IAU for suicide screening, assessing, and intervening (SSAIs) typically comprises pre-implementation preparation, didactic training, knowledge tests, experiential role plays, ongoing expert consultation, and providing certification status to clinicians who attain established benchmarks. Pre-implementation preparation included provision of materials. Didactic training occurred in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one consisted of materials we previously developed based on community clinician feedback. Part two followed established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also included supports for electronic health record integration (e.g., previously developed templates). After training, clinicians received 6 hours of expert consultation in small groups over 12 weeks to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU consisted of standard didactic training and ongoing consultation activities for enrolled clinicians |
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Baseline characteristics were captured from participants before randomization
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled, Not Yet Randomized | Participant information reported below include Aim 3 data captured before participants were randomized into EBIS or IAU conditions. After participants consented to study participation, they completed baseline measures. Participants were randomized after all participants were consented 1:1 by training date (EBIS or IAU). |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinician Perception of EBIS Acceptability for Clinical Practice at Time 4, 12 Weeks After Completing Training | Acceptability of EBIS was measured with the Acceptability of Intervention Measure (AIM), a 4-item, psychometrically-validated measure that indexes the extent to which stakeholders believe an implementation strategy is acceptable. Items on the AIM are rated on a 5-point Likert scale (Range = 4-20) and higher scores indicate greater acceptability. | After completing baseline measures, participants were randomized to training condition. By the end of the 12 week trial, 2 participants had dropped out of each study condition (n = 4). | Posted | Mean | Standard Deviation | units on a scale | Time 4: 12 weeks after completing training |
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exposure Based Implementation Strategy (EBIS) | EBIS is informed by the latest science in exposure theory, borrowing heavily from brief exposure-based treatments that can be delivered in a single session. We anticipate that EBIS will occur in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention; however, the final version will depend on the outcomes of the preparatory phases of this study. Clinicians assigned to the EBIS arm will also receive all elements of IAU. Exposure Based Implementation Strategy (EBIS): EBIS will include psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Becker-Haimes | University of Pennsylvania | 215-573-5614 | emily.haimes@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2024 | Jul 23, 2025 | Prot_SAP_000.pdf |
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| Implementation as Usual (IAU) | Behavioral | IAU will consist of standard didactic training and ongoing consultation activities for enrolled clinicians |
|
| Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks | Self-efficacy was measured via responses to two statements on a 7-point scale measuring clinicians' self-efficacy to use SSAIs, using established question stems from behavioral science (e.g., "If I really wanted to, I could screen every patient I see for suicide risk"). Self-efficacy was assessed separately for clinician self-efficacy for suicide screening and for use of the Safety Planning Intervention. Higher scores indicate greater self-efficacy. Scores were averaged for analysis (Range = 1 - 7). | Time 1: baseline measures completed before the training; Time 2: immediately after completing the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training |
| Screening Use at 3 Timepoints Across 12 Weeks | Use of clinician routine suicide screening in all patient encounters was indexed via chart-stimulated recall (CSR). CSR is an established technique for examining clinician decision-making and clinical processes beyond what can be determined from chart review or self-report alone. A research team member reviewed the clinician's deidentified caseload with them for the past clinic week. For each patient seen that week, the researcher asked brief questions related to the clinicians' suicide-related practices around screening for suicide risk. Results below report the proportion of patients clinicians screened for suicide out of the total number of patients seen on one clinical day. | Time 1: baseline measures completed before the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training |
| Safety Planning Intervention Use (Fidelity) at Time 3 (Two Weeks After Completing the Training) and Time 4 (12 Weeks After Completing the Training) | SPI Fidelity was indexed at Time 3 and Time 4 through case vignettes and standardized role play methodology. Participants received a vignette and prepare for a 45-60-minute role play, during which they were asked to complete an SPI with a patient who was determined to be at-risk for suicide following Columbia Suicide Severity Rating Scale (CSSRS) administration. Role plays were audio-recorded and coded for competence with the Safety Planning Intervention Rating Scale (SPIRS), developed by INSPIRE MPI G. Brown. This observational scale include 6 items on general safety plan intervention skills and 6 items which mapped onto the safety plan steps on a 4-point scale (0=not present to 3=excellent). Total scores were calculated by summing the 12 items with higher scores indicating greater SPI fidelity. | Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Implementation as Usual (IAU) | Gold-standard IAU for SSAIs typically comprises pre-implementation preparation, didactic training, knowledge tests, experiential role plays, ongoing expert consultation, and providing certification status to clinicians who attain established benchmarks. Pre-implementation preparation included provision of materials. Didactic training occurred in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one consisted of materials we previously developed based on community clinician feedback. Part two followed established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also included supports for electronic health record integration (e.g., previously developed templates). After training, clinicians received 6 hours of expert consultation in small groups over 12 weeks to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU consisted of standard didactic training and ongoing consultation activities for enrolled clinicians |
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| Primary | Clinician Perception of EBIS Feasibility and Utility for Clinical Practice at Time 4, 12 Weeks After Completing Training | Feasibility of EBIS was measured with the Feasibility of Intervention Measure (FIM), a 4-item measure that indexes the extent to which an implementation strategy is perceived as feasible. Items on the FIM are rated on a 5-point Likert scale (Range = 4-20) and higher scores indicate greater acceptability. | After completing baseline measures, participants were randomized to training condition. By the end of the 12 week trial, 2 participants had dropped out of each study condition (n = 4). | Posted | Mean | Standard Deviation | units on a scale | Time 4: 12 weeks after completing training |
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| Secondary | Clinician Anxiety at 4 Timepoints Across 12 Weeks | Clinician anxiety was assessed via 10-point Subjective Units of Distress (SUDS), a 10-point Likert rating of subjective distress where 1 = Not at all Distressed and 10 = Very Distressed. Clinicians rated their anxiety on screening and safety planning separately. | This measure was completed across four timepoints. 2 participants dropped out of the study after post-intervention measures. 2 additional participants dropped out after two week follow up measures | Posted | Mean | Standard Deviation | units on a scale | Time 1: baseline measures completed before the training; Time 2: immediately after completing the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training. |
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| Secondary | Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks | Self-efficacy was measured via responses to two statements on a 7-point scale measuring clinicians' self-efficacy to use SSAIs, using established question stems from behavioral science (e.g., "If I really wanted to, I could screen every patient I see for suicide risk"). Self-efficacy was assessed separately for clinician self-efficacy for suicide screening and for use of the Safety Planning Intervention. Higher scores indicate greater self-efficacy. Scores were averaged for analysis (Range = 1 - 7). | This measure was completed across four timepoints. 2 participants dropped out of the study after post-intervention measures. 2 additional participants dropped out after two week follow up measures | Posted | Mean | Standard Deviation | units on a scale | Time 1: baseline measures completed before the training; Time 2: immediately after completing the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training |
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| Secondary | Screening Use at 3 Timepoints Across 12 Weeks | Use of clinician routine suicide screening in all patient encounters was indexed via chart-stimulated recall (CSR). CSR is an established technique for examining clinician decision-making and clinical processes beyond what can be determined from chart review or self-report alone. A research team member reviewed the clinician's deidentified caseload with them for the past clinic week. For each patient seen that week, the researcher asked brief questions related to the clinicians' suicide-related practices around screening for suicide risk. Results below report the proportion of patients clinicians screened for suicide out of the total number of patients seen on one clinical day. | This measure was completed across 3 timepoints. 2 participants dropped out of the study after post-intervention measures. 2 additional participants dropped out after two week follow up measures | Posted | Mean | Standard Deviation | units | Time 1: baseline measures completed before the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training |
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| Secondary | Safety Planning Intervention Use (Fidelity) at Time 3 (Two Weeks After Completing the Training) and Time 4 (12 Weeks After Completing the Training) | SPI Fidelity was indexed at Time 3 and Time 4 through case vignettes and standardized role play methodology. Participants received a vignette and prepare for a 45-60-minute role play, during which they were asked to complete an SPI with a patient who was determined to be at-risk for suicide following Columbia Suicide Severity Rating Scale (CSSRS) administration. Role plays were audio-recorded and coded for competence with the Safety Planning Intervention Rating Scale (SPIRS), developed by INSPIRE MPI G. Brown. This observational scale include 6 items on general safety plan intervention skills and 6 items which mapped onto the safety plan steps on a 4-point scale (0=not present to 3=excellent). Total scores were calculated by summing the 12 items with higher scores indicating greater SPI fidelity. | This measure was completed across 2 timepoints. 2 participants dropped out after two week follow up measures | Posted | Mean | Standard Deviation | score on a scale | Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training |
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| 0 |
| 18 |
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| 18 |
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| 18 |
| EG001 | Implementation as Usual (IAU) | Gold-standard IAU for SSAIs typically comprises pre-implementation preparation, didactic training, knowledge tests, experiential role plays, ongoing expert consultation, and providing certification status to clinicians who attain established benchmarks. Pre-implementation preparation will include provision of materials. Didactic training will occur in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one will consist of materials we previously developed based on community clinician feedback. Part two will follow established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also will include supports for electronic health record integration (e.g., previously developed templates). After training, clinicians will receive 8 weeks of expert consultation to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU will consist of standard didactic training and ongoing consultation activities for enrolled clinicians | 0 | 18 | 0 | 18 | 0 | 18 |
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| Time 1: SUDS, planning |
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| Time 2: SUDS, screening |
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| Time 2: SUDS, planning |
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| Time 3: SUDS, screening |
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| Time 4: SUDS, screening |
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| t-test, 2 sided |
| .40 |
| Superiority |
| Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 3: two weeks after completing the training | t-test, 2 sided | .56 | Superiority |
| Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 4: 12 weeks after completing the training | t-test, 2 sided | .68 | Superiority |
| Repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS screening at timepoints 1, 3, and 4 | ANCOVA | .87 | Superiority |
| repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS planning at timepoints 1, 3, and 4 | ANCOVA | .43 | Superiority |
| Time 1, intervention |
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| Time 2, screening |
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| Time 2, intervention |
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| Time 3, screening |
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| Time 3, intervention |
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| Time 4, screening |
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| Time 4, intervention |
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| t-test, 2 sided |
| .59 |
| Superiority |
| Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 3: two weeks after completing the training | t-test, 2 sided | .25 | Superiority |
| Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 4: 12 weeks after completing the training | t-test, 2 sided | .35 | Superiority |
| repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy screening at timepoints 1, 3, and 4 | ANCOVA | .88 | Superiority |
| repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy intervening at timepoints 1, 3, and 4 | ANCOVA | .71 | Superiority |
| Time 3 |
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| Time 4 |
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| t-test, 2 sided |
| .55 |
| Superiority |
| repeated measures analysis of covariance (ANCOVA), controlling for organization: CSR screening at timepoints 1, 3, and 4 | ANCOVA | .36 | Superiority |
| Time 4: total SPIRS score |
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| t-test, 2 sided |
| .88 |
| Superiority |
| repeated measures analysis of covariance (ANCOVA), controlling for organization: SPIRS at timepoints 3 and 4 | ANCOVA | .10 | Superiority |