Trial Outcomes & Findings for Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART (NCT NCT02442869)

NCT ID: NCT02442869

Last Updated: 2021-03-01

Results Overview

The Client Satisfaction Questionnaire (CSQ-8) Therapist Version assesses therapist satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQT score of 8-20); Medium satisfaction ratings (CSQT score of 21-26); High satisfaction ratings (CSQT score of 27-32).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)
• Results posted on: 2021-03-01

Participant Flow

Participant milestones

Measure	Stage 1 TAU (Participant Responding to Treatment) Treatment as usual \[TAU\] -- the treatment typically provided by the counselor for 4-8 weeks. After 8 weeks or after participants completed their Stage 1 TAU treatment, whichever was later, they returned for their post Stage 1 assessment.	Stage 1 CAMS (Participant Responding to Treatment) Collaborative Assessment and Management of Suicidality \[CAMs\] -- treatment provided by counselor for 4-8 weeks. After 8 weeks or after participants completed their Stage 1 CAMS treatment, whichever was later, they returned for their post Stage 1 assessment.	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) Collaborative Assessment and Management of Suicidality (CAMS) -- treatment provided by counselor for 4-16 weeks. 16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 CAMS treatment, whichever was later, they returned for their post Stage 2 assessment.	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) Collaborative Assessment and Management of Suicidality (CAMS) -- treatment provided by counselor for 4-16 weeks. 16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 CAMS treatment, whichever was later, they returned for their post Stage 2 assessment.	Stage 2 DBT (Didn't Respond to Stage 1 TAU) Dialectical Behavioral Therapy (DBT) course -- treatment provided by counselor for 4-16 weeks. 16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 DBT treatment, whichever was later, they returned for their post Stage 2 assessment.	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) Dialectical Behavioral Therapy (DBT) course -- treatment provided by counselor for 4-16 weeks. 16 weeks after participants completed their post Stage 1 assessment or after participants completed their Stage 2 DBT treatment, whichever was later, they returned for their post Stage 2 assessment.
Overall Study STARTED	18	29	6	2	5	2
Overall Study COMPLETED	13	20	6	1	3	2
Overall Study NOT COMPLETED	5	9	0	1	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART

Baseline characteristics by cohort

Measure	Stage 1 TAU (Participant Responding to Treatment) n=18 Participants Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided. Participant responded to TAU, treatment ended.	Stage 1 CAMS (Participant Responding to Treatment) n=29 Participants Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS). Participant responded to CAMS, treatment ended.	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) n=6 Participants Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) n=2 Participants Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) n=5 Participants Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) n=2 Participants Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Total n=62 Participants Total of all reporting groups
Age, Continuous	20.50 years n=5 Participants	19.62 years n=7 Participants	20.50 years n=5 Participants	18.5 years n=4 Participants	20.60 years n=21 Participants	18.50 years n=8 Participants	19.97 years n=8 Participants
Age, Customized < 18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Between 18 and 65 years	18 Participants n=5 Participants	29 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=8 Participants	62 Participants n=8 Participants
Age, Customized > 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex/Gender, Customized Female	12 Participants n=5 Participants	18 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	42 Participants n=8 Participants
Sex/Gender, Customized Male	6 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	19 Participants n=8 Participants
Sex/Gender, Customized Transgender	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	10 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic/Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	15 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	30 Participants n=8 Participants
Race/Ethnicity, Customized More than one race	8 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	15 Participants n=8 Participants
Region of Enrollment United States	18 participants n=5 Participants	29 participants n=7 Participants	6 participants n=5 Participants	2 participants n=4 Participants	5 participants n=21 Participants	2 participants n=8 Participants	62 participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline

Number of students approached who agreed to participate in the study

Outcome measures

Measure	Agreed to Participate n=62 Participants Number of eligible students approached who agreed to participate	Declined to Participate n=30 Participants Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Feasibility/Acceptability: Participation Rate	18 Participants	29 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline

Population: Note the 'Overall Number of Participants Analyzed' in this context is the total number of eligible students and not the total number who consented to participate (intent to treat).

Two typologies as to when students declined to participate emerged: Declined when approached, and Declined during the consenting process.

Outcome measures

Measure	Agreed to Participate n=92 Participants Number of eligible students approached who agreed to participate	Declined to Participate Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why Declined when approached by counselor	23 students	—	—	—	—	—
Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why Declined during the consenting process	7 students	—	—	—	—	—
Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why Agreed: Enrolled & Randomized in study	62 students	—	—	—	—	—

PRIMARY outcome

Timeframe: After Stage 2

Population: All participants were assessed at the end of the Stage 2 (approximately 6 months after baseline), regardless of whether they continued into Stage 2 treatments or not

Feasibility/Acceptability (Treatment Retention): Number of students who were retained within each of the four Adaptive Treatment Strategies

Outcome measures

Measure	Agreed to Participate n=18 Participants Number of eligible students approached who agreed to participate	Declined to Participate n=29 Participants Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) n=6 Participants Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) n=2 Participants Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) n=5 Participants Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) n=2 Participants Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies Retained	13 Participants	20 Participants	6 Participants	1 Participants	3 Participants	2 Participants
Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies Dropped	5 Participants	9 Participants	0 Participants	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)

Population: Columns/Arms with zero (0) participants indicates that no participants dropped out of that particular Arm of the study, but note the small sample size. All participants were assessed at the end of the Stage 2 (approximately 6 months after baseline), regardless of whether they continued into Stage 2 treatments or not

General time to drop out among students who dropped out within each arm, by number of treatment sessions received

Outcome measures

Measure	Agreed to Participate n=5 Participants Number of eligible students approached who agreed to participate	Declined to Participate n=9 Participants Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) n=1 Participants Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) n=2 Participants Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm Attended 0 sessions	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm Attended 1-2 sessions	2 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm Attended 3-5 sessions	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm Attended 6 or more sessions	2 Participants	3 Participants	0 Participants	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)

Population: The first four sessions of randomly selected CAMS Stage 1 cases were rated for adherence for each counselor. An overall mean and then an overall count of 'Adherent' or 'Not Adherent' was created. The following reported data only reflects the overall adherence ratings (1 item). All participants were assessed at the end of the Stage 2 (approximately 6 months after baseline), regardless of whether they continued into Stage 2 treatments or not

CAMS adherence ratings conducted by CAMS experts. The CAMS Rating Scale (CRS.3) was used to assess CAMS adherence. The CRS.3 has 14 items rated on a 7-point scale from 0 (Poor) to 6 (Excellent). Therefore, higher scores indicate better adherence. Adherence covers various domains: collaboration (4 items), suicide focus (1 item), risk assessment (1 item), treatment planning (3 items), intervention (2 items), and overall adherence (1 item). Two coders assessed the fidelity of CAMS by observing digitally recorded sessions.

Outcome measures

Measure	Agreed to Participate n=50 Number of sessions rated for adherence Number of eligible students approached who agreed to participate	Declined to Participate n=6 Number of sessions rated for adherence Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) n=2 Number of sessions rated for adherence Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by "Real World" CCC Counselors Via the CAMS Rating Scale 3 (CRS.3) # Not Adherent (< 3)	2 Number of sessions rated for adherence	0 Number of sessions rated for adherence	0 Number of sessions rated for adherence	—	—	—
Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by "Real World" CCC Counselors Via the CAMS Rating Scale 3 (CRS.3) # Adherent (3 or above)	48 Number of sessions rated for adherence	6 Number of sessions rated for adherence	2 Number of sessions rated for adherence	—	—	—

PRIMARY outcome

Timeframe: During Stage 2 (sessions 9 through 24 of treatment)

Population: Approximately 1-2 DBT session tapes per five counselors (two counselors did not have available tapes) were semi-randomly selected and rated for adherence. It should be noted that DBTACS adherence scores are specific to a given session and only when multiple consecutive sessions are rated is the conclusion that a therapist is "adherent" warranted.

DBT adherence ratings conducted by DBT adherence experts. The University of Washington Dialectical Behavior Therapy Adherence Coding Scale (DBTACS) was utilized to check DBT adherence. The DBTACS has various dimensions, each measured on a 5-point scale (ranging from 0.0-5.0, with 5 indicating greater adherence). Therefore, higher scores indicate better adherence. The overall score is an average of these dimensions with a cutoff of 4.0 for adherence.

Outcome measures

Measure	Agreed to Participate n=4 Number of sessions rated for adherence Number of eligible students approached who agreed to participate	Declined to Participate n=3 Number of sessions rated for adherence Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Feasibility/Acceptability: Fidelity of the DBT Intervention Delivery by "Real World" CCC Counselors Via the University of Washington DBT Adherence Rating Scale (Linehan & Korslund, 2003) # Not Adherent (Below 4.0)	0 Number of sessions rated for adherence	1 Number of sessions rated for adherence	—	—	—	—
Feasibility/Acceptability: Fidelity of the DBT Intervention Delivery by "Real World" CCC Counselors Via the University of Washington DBT Adherence Rating Scale (Linehan & Korslund, 2003) # Adherent (4.0 or above)	4 Number of sessions rated for adherence	2 Number of sessions rated for adherence	—	—	—	—

PRIMARY outcome

Timeframe: End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)

Population: Not all participants completed measures following Stage 2, therefore although fourteen clients were re-randomized to S2, only eleven completed the CSQ.

The Client Satisfaction Questionnaire (CSQ-8) assesses client satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQ score of 8-20); Medium satisfaction ratings (CSQ score of 21-26); High satisfaction ratings (CSQ score of 27-32).

Outcome measures

Measure	Agreed to Participate n=13 Participants Number of eligible students approached who agreed to participate	Declined to Participate n=24 Participants Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) n=5 Participants Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) n=2 Participants Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) n=5 Participants Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) n=2 Participants Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8) Stage 1	27.54 score on a scale Standard Deviation 3.99	27.96 score on a scale Standard Deviation 4.09	27.00 score on a scale Standard Deviation 4.00	27.00 score on a scale Standard Deviation 2.82	25.00 score on a scale Standard Deviation 2.65	28.00 score on a scale Standard Deviation 4.24
Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8) Stage 2	27.17 score on a scale Standard Deviation 4.28	28.04 score on a scale Standard Deviation 3.64	28.80 score on a scale Standard Deviation 3.83	22.00 score on a scale Standard Deviation 8.49	25.00 score on a scale Standard Deviation 2.00	32.00 score on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)

Population: The unit of analysis is participants, however, counselors completed the Client Satisfaction Questionnaire Therapist Version (CSQT-8).

The Client Satisfaction Questionnaire (CSQ-8) Therapist Version assesses therapist satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQT score of 8-20); Medium satisfaction ratings (CSQT score of 21-26); High satisfaction ratings (CSQT score of 27-32).

Outcome measures

Measure	Agreed to Participate n=18 Participants Number of eligible students approached who agreed to participate	Declined to Participate n=28 Participants Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) n=5 Participants Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) n=2 Participants Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) n=5 Participants Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) n=2 Participants Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version) Stage 1	26.83 score on a scale Standard Deviation 4.38	25.18 score on a scale Standard Deviation 6.51	23.33 score on a scale Standard Deviation 5.39	21.50 score on a scale Standard Deviation 2.12	21.80 score on a scale Standard Deviation 4.60	22.00 score on a scale Standard Deviation 2.83
Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version) Stage 2	24.59 score on a scale Standard Deviation 6.00	25.00 score on a scale Standard Deviation 6.40	25.25 score on a scale Standard Deviation 2.50	23.00 score on a scale Standard Deviation 5.66	23.50 score on a scale Standard Deviation 3.11	30.00 score on a scale Standard Deviation NA sample of 1, no Std Dev. to calculate

SECONDARY outcome

Timeframe: End of Stage 1 interventions - ~8 weeks after baseline; End of Stage 2 interventions ~24 weeks after baseline; and Follow-up (3 months after all treatment has ended) ~36 weeks after baseline

Population: Not all participants were assessed at S1 due to several participants declining assessments or missing the assessment window. Data are only included for S1 treatment arms in line with our pre-specified research aim to obtain estimates of overall response rates to S1 interventions. Clinical outcome variables were not interpreted at Stage 2 because it was exploratory in nature focusing on the feasibility/acceptability of implementing a SMART design to address suicidal risk in college students.

The SSI is an interviewer-rated measure based on 19 questions related to the highest intensity of suicidal ideation in the past 2 weeks, including attitudes, behaviors, and plans. Each item is rated as 0,1, or 2 and the total scale yields a score of 0-38. Higher scores indicate greater suicide risk.

Outcome measures

Measure	Agreed to Participate n=29 Participants Number of eligible students approached who agreed to participate	Declined to Participate n=33 Participants Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Scale for Suicide Ideation-Current (SSI) Baseline	13.72 score on a scale Standard Deviation 7.07	13.79 score on a scale Standard Deviation 5.13	—	—	—	—
Scale for Suicide Ideation-Current (SSI) S1 (end of Phase I interventions) -8 weeks	7.35 score on a scale Standard Deviation 6.45	5.66 score on a scale Standard Deviation 6.44	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: The time frame at pretreatment was both lifetime and past 2 months at baseline: and all other assessments focused on the last 2 months. This was assessed at baseline and after Stage 1 (~ 8 weeks later).

Population: Note. Some attrition/respondent drop-out is present throughout this study. Data are only included for S1 treatment arms in line with our pre-specified research aim to obtain estimates of overall response rates to S1 interventions. Clinical outcome variables were not interpreted at Stage 2 because it was exploratory in nature focusing on the feasibility/acceptability of implementing a SMART design to address suicidal risk in college students.

The SASI-C is a very brief interview of past self-inflicted injuries, categorized into suicide attempts and nonsuicidal acts. The SASI-C creates counts of self-inflicted injuries by method, medical risk severity, and lethality.

Outcome measures

Measure	Agreed to Participate n=29 Participants Number of eligible students approached who agreed to participate	Declined to Participate n=33 Participants Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
The Suicide Attempt and Self-Injury Count (SASI-C) Baseline : SASI-C (endorsed suicide attempt in last 2 month)	7 Participants	3 Participants	—	—	—	—
The Suicide Attempt and Self-Injury Count (SASI-C) Baseline : SASI-C (1 or more self-inflicted injuries)	24 Participants	26 Participants	—	—	—	—
The Suicide Attempt and Self-Injury Count (SASI-C) Post Stage 1 : SASI-C (endorsed suicide attempt in last 2 months)	0 Participants	0 Participants	—	—	—	—
The Suicide Attempt and Self-Injury Count (SASI-C) Post Stage 1 : SASI-C (1 or more self-inflicted injuries)	9 Participants	7 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and End of Stage 1 interventions - 8 weeks after baseline

Population: Note: Some attrition/respondent drop-out is present throughout this study. Data are only included for S1 treatment arms in line with our pre-specified research aim to obtain estimates of overall response rates to S1 interventions. Clinical outcome variables were not interpreted at Stage 2 because it was exploratory in nature focusing on the feasibility/acceptability of implementing a SMART design to address suicidal risk in college students.

The CCAPS-34 is a measure of psychological distress with several sub-scales (Depression) specifically designed for college students seeking services. Depression subscale scores range from 0.1-5.0 with lower scores representing less depression

Outcome measures

Measure	Agreed to Participate n=29 Participants Number of eligible students approached who agreed to participate	Declined to Participate n=33 Participants Number of eligible students approached who declined to participate	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
The Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale. Baseline	1.98 score on a scale Standard Deviation 1.06	2.23 score on a scale Standard Deviation 0.99	—	—	—	—
The Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale. Stage 1	1.70 score on a scale Standard Deviation 0.90	1.42 score on a scale Standard Deviation 1.70	—	—	—	—

Adverse Events

Stage 1 TAU (Participant Responding to Treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stage 1 CAMS (Participant Responding to Treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stage 2 CAMS (Didn't Respond to Stage 1 TAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Stage 2 DBT (Didn't Respond to Stage 1 TAU)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Stage 2 DBT (Didn't Respond to Stage 1 CAMS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stage 1 TAU (Participant Responding to Treatment) n=18 participants at risk Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided. Participant responded to TAU, treatment ended.	Stage 1 CAMS (Participant Responding to Treatment) n=29 participants at risk Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS). Participant responded to CAMS, treatment ended.	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) n=6 participants at risk Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) n=2 participants at risk Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Stage 2 DBT (Didn't Respond to Stage 1 TAU) n=5 participants at risk Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) n=2 participants at risk Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Social circumstances Death by Suicide	0.00% 0/18 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/29 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/6 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/5 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.
Social circumstances Other Death	0.00% 0/18 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/29 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/6 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/5 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.
Social circumstances Attempted Suicide	0.00% 0/18 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/29 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/6 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	50.0% 1/2 • Number of events 1 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	20.0% 1/5 • Number of events 1 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.
Social circumstances Non-Suicidal Self-Injury	0.00% 0/18 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/29 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/6 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	50.0% 1/2 • Number of events 1 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/5 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.
Social circumstances Psychiatric Admission	0.00% 0/18 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/29 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/6 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	20.0% 1/5 • Number of events 1 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.
Social circumstances Medical Hospitalization	0.00% 0/18 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/29 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/6 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/5 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.
Nervous system disorders Other Serious Adverse Event	0.00% 0/18 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/29 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/6 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	20.0% 1/5 • Number of events 1 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.	0.00% 0/2 • Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months). Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacqueline Pistorello

University of Nevada, Reno

Phone: 775-784-4648

Email: pistorel@unr.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place