Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Pro00103346 | Other Identifier | Duke IRB | |
| R01MH116062 | U.S. NIH Grant/Contract | View source | |
| R01MH116052 | U.S. NIH Grant/Contract | View source | |
| R01MH116050 | U.S. NIH Grant/Contract | View source | |
| R01MH116061 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Suicide is the 2nd leading cause of death among college students and suicidal ideation and suicide-related behaviors are a frequent presenting problem at college counseling centers (CCCs), which are overburdened. Studies show that some students respond rapidly to treatment, whereas others require considerably more resources. Evidence-based adaptive treatment strategies (ATSs) are needed to address this heterogeneity in responsivity and complexity. ATSs individualize treatment via decision rules specifying how the type and intensity of an intervention can be sequenced based on risk factors, response, or compliance.
The purpose of this multisite study is to investigate the effectiveness of four adaptive treatment strategies (ATSs) to treat college students who report suicidal ideation when first seeking services at their college counseling center This multisite study will enroll moderately to severely suicidal college students in the "emerging adulthood" phase (ages 18-25) seeking services at CCCs. This Sequential Multi-Assignment Randomized Trial (SMART) will have two stages of intervention. In Stage 1, 700 participants from four CCCs will be randomized to 4-8 weeks of: 1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) or 2) Treatment as Usual (TAU). Sufficient responders to either intervention will discontinue services/be stepped down. Non-responders will be re-randomized to one of two Stage 2 higher intensity/dosage intervention options for an additional 4-16 weeks: 1) CAMS (either continued or administered for the first time) or 2) Comprehensive Dialectical Behavior Therapy (DBT), which includes individual therapy, skills group, and phone/text coaching for the clients and peer consultation for the counselors.
We will enroll moderately to severely suicidal college students in the "emerging adulthood" phase (ages 18-25) seeking services at CCCs. Eighty-Five participants (N=85) from four CCCs will be randomized to one of three treatments delivered via a hybrid model: (1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks (n=35); (2) Treatment as Usual (TAU) for 4-8 weeks (n=15); or (3) Comprehensive Dialectical Behavior Therapy (DBT) for 16 weeks (n=35), which includes individual therapy, skills training, phone/text coaching for the clients, and peer consultation for the counselors.
Sufficient responders to CAMS or TAU will discontinue services/be stepped down after 4-8 weeks. Non-responders to CAMS or TAU will be re-randomized to one of two higher intensity/dosage intervention options for an additional 8 weeks of treatment: (1) CAMS (either continued or administered for the first time) or (2) Comprehensive DBT.
For the feasibility study, we will also enroll 12 CCC counselors (3 per site) who will serve as study counselor participants and periodically complete measures focused on the experience of counselors working with suicidal college students.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAMS to Maintenance | Experimental | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring. |
|
| CAMS to CAMS | Experimental | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS. |
|
| CAMS to DBT | Experimental | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT. |
|
| TAU to Maintenance | Experimental | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring. |
|
| TAU to CAMS | Experimental | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAU - Phase 1 | Behavioral | 4-8 weeks of TAU treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eligible Students Who Agree to Randomization | Among students who are eligible to participate in the study and approached about the study by an intake worker, the number who agree to randomization to one of three treatments will be reported. | To the end of initial Randomization (up to 1 week) |
| Counselor Recruitment | Among the counselors eligible to participate in the study, the number of counselors from each site who agree to participate. | To the end of initial counselor recruitment (up to 2 weeks) |
| Treatment Adherence as Measured by DBT (Dialectical Behavior Therapy) Adherence Rating Scale | Existing gold-standard adherence instruments for DBT will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. Each item is rated on a scale where 0 = not used/not necessary, 1-3 = below adherence, 4 = minimum threshold for adherence, and 5 = adherent with high sufficiency. The DBT ACS is scored by averaging all non-zero items to create a computed global score where 3.8 and higher is considered "adherent." | To the end of treatment period (up to 16 weeks) |
| Treatment Adherence as Measured by CAMS (Collaborative Assessment and Management of Suicidality) Adherence Rating Scale | Existing gold-standard adherence instruments for CAMS will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. The measure consists of 14 items evaluating clinician performance, all rated on a seven-point Likert scale ranging from 0 ("Poor") to 6 ("Excellent"). A session is rated as adherent with a score of 3.5 or greater. | To the end of treatment period (up to 16 weeks) |
| Number of Sessions Attended by Students in Each Treatment Condition |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott Compton, PhD | Duke University | Principal Investigator |
| Jacqueline Pistorello, PhD | University of Nevada at Reno (UNR) | Principal Investigator |
| Shireen Rizvi, PhD | Rutgers University | Principal Investigator |
| John Seeley, PhD | University of Oregon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada - Reno | Reno | Nevada | 89557 | United States | ||
| Rutgers University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39439041 | Derived | Kassing F, Seeley JR, Rizvi SL, Compton SN, Sinclair J, Oshin LA, Blalock K, Jobes DA, Crumlish J, Stadelman S, Gozenman-Sapin F, Snyderman T, Ruork AK, Fry CM, Gallop RJ, Goodrich J, Pistorello J. Assessing the implementation of suicide-focused treatments delivered in hybrid telemental health format in a real-world setting. Psychother Res. 2025 Sep;35(7):1198-1212. doi: 10.1080/10503307.2024.2415104. Epub 2024 Oct 22. |
Not provided
Not provided
We will participant de-identified data (linked only by GUID) with the National Institute of Mental Health Data Archive (NDA). The NDA is an informatics system and research data repository developed by the National Institutes of Health (NIH) to share research data. The NDA provides the infrastructure to store, search across, and analyze various types of data. In addition, The NDA provides longitudinal storage of a research participant's information generated by one or more research studies. In other words, the NDA is able to associate a single research participant's genomic, imaging, clinical assessment and other information even if the data were collected at different locations or through different studies. By doing so, the NDA gives researchers access to more data than they can collect on their own, making it easier and faster for researchers to gather, evaluate, and share research information from a variety of sources.
All subject data will be submitted for inclusion in the NDA, through the conclusion of data collection activities. Data is to be submitted cumulatively, every 6 months.
The NIH will provide access to scientific investigators for research purposes. Qualified researchers who have completed a Data Use Certification and received approval from the NDA Data Access Committee (DAC) may be approved to access broadly shared data. A separate request process exists for access to data in federated sources. Additionally, the DAC and support staff at NIH have access to NDA shared data.
While they were consented to assure they fully understood the rights and responsibilities of their study role, data about Study Counselors is not collected as it is for the Student Participants. Per CT.gov request, they are however being included as a separate 8th Arm/Group for purposes of this data reporting.
College students seeking treatment at college counseling center. Eligible students endorsed suicidal thoughts at intake.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CAMS to Maintenance | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring. CAMS - Phase 1: 4-8 weeks of CAMS treatment |
| FG001 | CAMS to CAMS | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS. CAMS - Phase 1: 4-8 weeks of CAMS treatment CAMS - Phase 2: Up to 8 weeks of CAMS treatment |
| FG002 | CAMS to DBT | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT. CAMS - Phase 1: 4-8 weeks of CAMS treatment DBT - Phase 2: Up to 8 weeks of DBT treatment |
| FG003 | TAU to Maintenance | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring. TAU - Phase 1: 4-8 weeks of TAU treatment |
| FG004 | TAU to CAMS | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS. TAU - Phase 1: 4-8 weeks of TAU treatment CAMS - Phase 2: Up to 8 weeks of CAMS treatment |
| FG005 | TAU to DBT | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT. TAU - Phase 1: 4-8 weeks of TAU treatment DBT - Phase 2: Up to 8 weeks of DBT treatment |
| FG006 | DBT Only | Subject Assigned to DBT for Phase 1, continuing up to 16 weeks. DBT - Phase 1 and 2: up to 16 weeks of DBT treatment |
| FG007 | Study Counselors | Consented Study Counselors from each of the 4 sites. Data collected regarding the Counselors is minimal and is maintained completely separately from the other 7 Student Participant Arms/Groups. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
While they were consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. Therefore, they are not deemed a relevant Arm/group for reporting purposes here.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CAMS to Maintenance | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring. CAMS - Phase 1: 4-8 weeks of CAMS treatment |
| BG001 | CAMS to CAMS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | {Note:While Counselor age data was provided, it was not included in determining the overall Mean and Standard deviations of the study participants because the study itself is focused on the students, including a maximum age Exclusion for student participants. Those numbers were derived for the 68 Student participants alone.} |
| 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 | Number of Eligible Students Who Agree to Randomization | Among students who are eligible to participate in the study and approached about the study by an intake worker, the number who agree to randomization to one of three treatments will be reported. | Students meeting all inclusion criteria and no exclusion criteria. | Posted | Count of Participants | Participants | To the end of initial Randomization (up to 1 week) |
|
To the end of study (up to 9 months)
While consented to assure they fully understood the rights and responsibilities of their study role, Study Counselors are not considered enrolled as study subjects. They are not deemed a relevant Arm/group for reporting purposes here. Adverse Events were only collected in regards to treatment subjects.
Regarding Arm "DBT Only", there was no formal separation into Stage 1/2 of treatment as it was one, longer, course of DBT. Therefore, all related data is accumulated under that single Arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage 2 - CAMS to Maintenance | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring. CAMS - Phase 1: 4-8 weeks of CAMS treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Evidence of distress during assessments | Psychiatric disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Compton, Ph.D. | Duke University | 919-668-0063 | compt004@duke.edu |
Not provided
| 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 | Apr 8, 2023 | Oct 10, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2022 | Jun 22, 2022 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Participants will be randomized to one of three treatments delivered via a hybrid model: (1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks (n=35); (2) Treatment as Usual (TAU) for 4-8 weeks (n=15); or (3) Comprehensive Dialectical Behavior Therapy (DBT) for 16 weeks (n=35), which includes individual therapy, skills training, phone/text coaching for the clients, and peer consultation for the counselors.
Sufficient responders to CAMS or TAU will discontinue services/be stepped down after 4-8 weeks. Non-responders to CAMS or TAU will be re-randomized to one of two higher intensity/dosage intervention options for an additional 8 weeks of treatment: (1) CAMS (either continued or administered for the first time) or (2) Comprehensive DBT.
There is an 8th Arm/Group of Consented Study Counselors from each of the 4 sites.
Not provided
Not provided
Not provided
| TAU to DBT | Experimental | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT. |
|
| DBT Only | Experimental | Subject Assigned to DBT for Phase 1, continuing up to 16 weeks. |
|
| Study Counselors | No Intervention | Consented Study Counselors from each of the 4 sites. Data collected regarding the Counselors is minimal and is maintained completely separately from the other 7 Student Participant Arms/Groups. |
| CAMS - Phase 1 | Behavioral | 4-8 weeks of CAMS treatment |
|
| DBT - Phase 1 and 2 | Behavioral | up to 16 weeks of DBT treatment |
|
| CAMS - Phase 2 | Behavioral | Up to 8 weeks of CAMS treatment |
|
| DBT - Phase 2 | Behavioral | Up to 8 weeks of DBT treatment |
|
| To the end of treatment period (up to 16 weeks) |
| Number of Students Who Attrite From the Study (by Withdrawing Early From Treatment or Dropping Out of the Trial) | To the end of treatment period (up to 16 weeks) |
| Student Treatment Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ) | CSQ items are rated from 1-4, with higher scores reflecting greater satisfaction. | To the end of treatment period (up to 16 weeks) |
| Counselor Training Satisfaction | An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the Continuing Education Unit (CEU) evaluation surveys for the CAMS (Collaborative Assessment and Management of Suicidality) and DBT (Dialectical Behavior Therapy) online trainings. Item scores range from 1 (Not at all valuable) to 5 (Extremely valuable). | To end of initial training period (up to 4 weeks) |
| Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ) | An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment. | To the end of stage 1 (up to 8 weeks) |
| Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ) | An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment. | Beginning to end of Stage 2 (up to 8 weeks) |
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| University of Oregon | Eugene | Oregon | 97403 | United States |
| Physician Decision |
|
| Treatment drop |
|
| Study drop |
|
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
CAMS - Phase 1: 4-8 weeks of CAMS treatment
CAMS - Phase 2: Up to 8 weeks of CAMS treatment
| BG002 | CAMS to DBT | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT. CAMS - Phase 1: 4-8 weeks of CAMS treatment DBT - Phase 2: Up to 8 weeks of DBT treatment |
| BG003 | TAU to Maintenance | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring. TAU - Phase 1: 4-8 weeks of TAU treatment |
| BG004 | TAU to CAMS | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS. TAU - Phase 1: 4-8 weeks of TAU treatment CAMS - Phase 2: Up to 8 weeks of CAMS treatment |
| BG005 | TAU to DBT | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT. TAU - Phase 1: 4-8 weeks of TAU treatment DBT - Phase 2: Up to 8 weeks of DBT treatment |
| BG006 | DBT Only | Subject Assigned to DBT for Phase 1, continuing up to 16 weeks. DBT - Phase 1 and 2: up to 16 weeks of DBT treatment |
| BG007 | Study Counselors | Consented Study Counselors from each of the 4 sites. Data collected regarding the Counselors is minimal and is maintained completely separately from the other 7 Student Participant Arms/Groups. |
| BG008 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 |
| University of Nevada, Reno |
University of Nevada, Reno |
| OG003 | University of Oregon | University of Oregon (Eugene, OR) |
|
|
| Primary | Counselor Recruitment | Among the counselors eligible to participate in the study, the number of counselors from each site who agree to participate. | Counselors meeting all inclusion criteria and no exclusion criteria. | Posted | Count of Participants | Participants | To the end of initial counselor recruitment (up to 2 weeks) |
|
|
|
| Primary | Treatment Adherence as Measured by DBT (Dialectical Behavior Therapy) Adherence Rating Scale | Existing gold-standard adherence instruments for DBT will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. Each item is rated on a scale where 0 = not used/not necessary, 1-3 = below adherence, 4 = minimum threshold for adherence, and 5 = adherent with high sufficiency. The DBT ACS is scored by averaging all non-zero items to create a computed global score where 3.8 and higher is considered "adherent." | Participants whose DBT sessions were rated. | Posted | Mean | 95% Confidence Interval | score on a scale | To the end of treatment period (up to 16 weeks) | sessions | sessions |
|
|
|
| Primary | Treatment Adherence as Measured by CAMS (Collaborative Assessment and Management of Suicidality) Adherence Rating Scale | Existing gold-standard adherence instruments for CAMS will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. The measure consists of 14 items evaluating clinician performance, all rated on a seven-point Likert scale ranging from 0 ("Poor") to 6 ("Excellent"). A session is rated as adherent with a score of 3.5 or greater. | Participants whose CAMS sessions were rated. | Posted | Mean | 95% Confidence Interval | score on a scale | To the end of treatment period (up to 16 weeks) | sessions | sessions |
|
|
|
| Primary | Number of Sessions Attended by Students in Each Treatment Condition | Posted | Mean | Standard Deviation | sessions | To the end of treatment period (up to 16 weeks) |
|
|
|
| Primary | Number of Students Who Attrite From the Study (by Withdrawing Early From Treatment or Dropping Out of the Trial) | Posted | Count of Participants | Participants | To the end of treatment period (up to 16 weeks) |
|
|
|
| Primary | Student Treatment Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ) | CSQ items are rated from 1-4, with higher scores reflecting greater satisfaction. | Participants with data collected. | Posted | Mean | Standard Deviation | score on a scale | To the end of treatment period (up to 16 weeks) |
|
|
|
| Primary | Counselor Training Satisfaction | An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the Continuing Education Unit (CEU) evaluation surveys for the CAMS (Collaborative Assessment and Management of Suicidality) and DBT (Dialectical Behavior Therapy) online trainings. Item scores range from 1 (Not at all valuable) to 5 (Extremely valuable). | We had 16 total consented counselors, and 2 entire rounds of DBT training, which some attended twice. 8 counselors attended both (8x2=16), while 4 others attended Round 1 only and another 4 attended Round 2 only. Therefore, a total of 24 DBT training ratings for 16 counselors. Ten counselors attended one CAMS session each. | Posted | Mean | 95% Confidence Interval | score on a scale | To end of initial training period (up to 4 weeks) | Training sessions | Training sessions |
|
|
|
| Primary | Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ) | An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment. | Participants who completed Stage 1 of treatment. | Posted | Mean | 95% Confidence Interval | score on a scale | To the end of stage 1 (up to 8 weeks) |
|
|
|
| Primary | Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ) | An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment. | Participants who completed Stage 2 of treatment. | Posted | Mean | 95% Confidence Interval | score on a scale | Beginning to end of Stage 2 (up to 8 weeks) |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Stage 2 - CAMS to CAMS | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS. CAMS - Phase 1: 4-8 weeks of CAMS treatment CAMS - Phase 2: Up to 8 weeks of CAMS treatment | 0 | 5 | 0 | 8 | 0 | 5 |
| EG002 | Stage 2 - CAMS to DBT | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT. CAMS - Phase 1: 4-8 weeks of CAMS treatment DBT - Phase 2: Up to 8 weeks of DBT treatment | 0 | 9 | 0 | 9 | 1 | 9 |
| EG003 | Stage 2 - TAU to Maintenance | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring. TAU - Phase 1: 4-8 weeks of TAU treatment | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | Stage 2 - TAU to CAMS | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS. TAU - Phase 1: 4-8 weeks of TAU treatment CAMS - Phase 2: Up to 8 weeks of CAMS treatment | 0 | 7 | 0 | 7 | 0 | 7 |
| EG005 | Stage 2 - TAU to DBT | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT. TAU - Phase 1: 4-8 weeks of TAU treatment DBT - Phase 2: Up to 8 weeks of DBT treatment | 0 | 1 | 0 | 1 | 0 | 1 |
| EG006 | DBT Only | Subject Assigned to DBT for Phase 1, continuing up to 16 weeks. No 2nd phase is delineated. | 0 | 26 | 4 | 26 | 3 | 26 |
| EG007 | Stage 1 CAMS | All Subjects assigned to Stage 1 CAMS who had a relevant AE during Stage 1. | 0 | 30 | 4 | 30 | 9 | 30 |
| EG008 | Stage 1 TAU | All Subjects assigned to Stage 1 TAU who had a relevant AE during Stage 1. | 0 | 12 | 1 | 12 | 3 | 12 |
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
|
| Non-suicidal self-injury | Psychiatric disorders | Non-systematic Assessment |
|
| Other non-mental health event | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| sessions |
|
| sessions |
|
|
| Student CSQ at Stage 2 Treatment |
|
|