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Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART

Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02442869
Acronym
SMART
Enrollment
62
Registered
2015-05-13
Start date
2015-06-16
Completion date
2016-12-30
Last updated
2021-03-01

For informational purposes only โ€” not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

Suicide, College student mental health, CAMS- Collaborative Assessment and Management of Suicidality, SMART -- Sequential Multiple Assignment Randomized Trial, DBT -- Dialectical Behavior Therapy, ATS -- Adaptive Treatment Strategy

Brief summary

This pilot study tested the feasibility of utilizing an adaptive intervention strategy for college students who are suicidal when first seeking treatment at a campus clinic. Right now, the typical strategy may rely on a one size fits all approach, but in fact suicidal students vary greatly on what and how much they need. This study will pave the way for subsequent larger trials for clinical decision making (trying one approach, and if that doesn't work, another) to be empirically developed and tested in a subsequent large-scale multisite trial with the goal of maximizing resources in overburdened college counseling centers. This pilot study followed by a subsequent large-scale trial could eventually significantly impact service delivery to suicidal college students at college counseling centers.

Detailed description

The primary aim of this proposal was to conduct feasibility research to inform the implementation of a future full-scale SMART (sequential, multiple assignment, randomized trial, Almirall et al., 2012) that will be used to construct adaptive treatment strategies (ATSs) to address suicidality in college students seeking services at college counseling centers (CCCs). ATSs individualize treatment via decision rules that can specify how the type and intensity of an intervention should be sequenced based on variables collected mid-treatment (or at baseline), such as response to treatment. Suicidality is a frequent presenting concern among college students seeking treatment; yet, studies with this population show that some students respond rapidly to treatment whereas others may require considerably more resources. However, at this time, CCCs, which are overburdened and often have to resort to waitlists, have no guidance as to how to sequence different approaches with suicidal students in an empirically-based and cost effective manner. Therefore, empirically validated ATSs are needed in the provision of services to suicidal college students to address the heterogeneity of students with this presentation and the variability in response to interventions. In the present pilot SMART, each participant progressed through two stages of intervention. In the first stage (S1) 62 participants were randomized to one of two brief individual therapy interventions for 4-8 weeks: 1) one that is suicidality-focused (Collaborative Assessment and Management of Suicidality (CAMS; Jobes, 2016) and 2) one that relies on Treatment as Usual (TAU) being provided at a CCC. Responders to either program will discontinue services/ be stepped down and be monitored over time for maintenance. Non-responders to either intervention who remain in treatment (estimated n = 18) were re-randomized to one of two second-stage (S2) higher intensity/dosage intervention options for an additional 4-16 weeks: 1) CAMS (either continued but for a longer period of time or administered for the first time) or 2) Comprehensive Dialectical Behavior Therapy (DBT, Linehan, 1993a, 1993b) which includes individual therapy, skills groups, and phone coaching for the clients and DBT peer consultation for the therapists. This study enrolled moderately to severely suicidal (endorsing thoughts of wanting to die of 2 or above on 0-4 scale) college students in the emerging adulthood phase (18-25 years of age) seeking services at a CCC. The aims of this feasibility services research project were to 1) develop and refine a SMART design in a CCC setting; 2) assess the feasibility of conducting a SMART and its embedded ATSs in a CCC setting; 3) obtain estimates of overall response rates to S1 interventions; and 4) explore the utility of incorporating secondary tailoring variables (e.g., level of functioning at pre-treatment, ratio of Wish to Live vs. Wish to Die) in the ATSs in the subsequent larger trial.

Interventions

BEHAVIORALStage 1 Treatment as usual (TAU)

4-8 weeks of the treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.

BEHAVIORALStage 1 CAMS

4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)

BEHAVIORALStage 2 CAMS

4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)

BEHAVIORALStage 2 Dialectical Behavioral Therapy (DBT)

4-16 weeks of Dialectical Behavioral Therapy (DBT)

Sponsors

The Catholic University of America
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Nevada, Reno
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The Independent Evaluator was blind to condition assignment when conducting the assessments.

Intervention model description

This study used a Sequential Multiple Assignment Randomized Trial (SMART) design to pilot 4 adaptive treatment strategies (ATSs): ATS1 - Start with Stage 1 CAMS; if responding, end treatment; if not, continue on to Stage 2 CAMS. ATS2 - Start with Stage 1 CAMS; if responding, end treatment; if not, continue on to Stage 2 DBT. ATS3 - Start with Stage 1 TAU; if responding, end treatment; if not, continue on to Stage 2 CAMS. ATS4 - Start with Stage 1 TAU; if responding, end treatment; if not, continue on to Stage 2 DBT. For Stage 1, we hypothesized that CAMS would show more improvement on suicide-related variables than TAU and would be more effective with suicidal college students presenting with less complexity at baseline. We did not identify hypotheses for clinical outcome variables in Stage 2 because it was exploratory in nature and focused on the feasibility and acceptability of implementing a SMART design to address suicidal risk in college students.

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* Enrolled student at the University of Nevada, Reno (UNR) * Seeking services at Counseling Services at UNR * 18 to 25 years of age * Moderate to severe suicidality (indicated by a score of 2 or above (range is 0 not at all like me to 4 extremely like me) on the Counseling Center Assessment of Psychological Symptoms (CCAPS-34; Locke et al., 2012) question, I have thoughts of ending my life.

Exclusion criteria

* Individual is deemed inappropriate to receive services at UNR Counseling Services by the intake worker (the primary exclusion criterion). * Participant cannot have been in treatment at UNR Counseling Services within the previous 3 months.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)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).
Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by Real World CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)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.
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)During Stage 2 (sessions 9 through 24 of treatment)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.
Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)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).
Feasibility/Acceptability: Participation RateBaselineNumber of students approached who agreed to participate in the study
Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and WhyBaselineTwo typologies as to when students declined to participate emerged: Declined when approached, and Declined during the consenting process.
Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesAfter Stage 2Feasibility/Acceptability (Treatment Retention): Number of students who were retained within each of the four Adaptive Treatment Strategies
Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmThroughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)General time to drop out among students who dropped out within each arm, by number of treatment sessions received

Secondary

MeasureTime frameDescription
Scale for Suicide Ideation-Current (SSI)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 baselineThe 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.

Other

MeasureTime frameDescription
The Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.Baseline and End of Stage 1 interventions - 8 weeks after baselineThe 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
The Suicide Attempt and Self-Injury Count (SASI-C)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).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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Stage 1 TAU (Participant Responding to Treatment)
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.
18
Stage 1 CAMS (Participant Responding to Treatment)
Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS). Participant responded to CAMS, treatment ended.
29
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)
6
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)
2
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)
5
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)
2
Total62

Baseline characteristics

CharacteristicTotalStage 2 DBT (Didn't Respond to Stage 1 CAMS)Stage 1 TAU (Participant Responding to Treatment)Stage 1 CAMS (Participant Responding to Treatment)Stage 2 DBT (Didn't Respond to Stage 1 TAU)Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Stage 2 CAMS (Didn't Respond to Stage 1 TAU)
Age, Continuous19.97 years18.50 years20.50 years19.62 years20.60 years18.5 years20.50 years
Age, Customized
< 18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
> 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
Between 18 and 65 years
62 Participants2 Participants18 Participants29 Participants5 Participants2 Participants6 Participants
Race/Ethnicity, Customized
Asian
10 Participants0 Participants3 Participants5 Participants1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants1 Participants0 Participants1 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Hispanic/Latino
5 Participants0 Participants1 Participants3 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
More than one race
15 Participants1 Participants8 Participants5 Participants1 Participants0 Participants0 Participants
Race/Ethnicity, Customized
White
30 Participants0 Participants6 Participants15 Participants3 Participants1 Participants5 Participants
Region of Enrollment
United States
62 participants2 participants18 participants29 participants5 participants2 participants6 participants
Sex/Gender, Customized
Female
42 Participants2 Participants12 Participants18 Participants4 Participants1 Participants5 Participants
Sex/Gender, Customized
Male
19 Participants0 Participants6 Participants10 Participants1 Participants1 Participants1 Participants
Sex/Gender, Customized
Transgender
1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 290 / 60 / 20 / 50 / 2
other
Total, other adverse events
0 / 180 / 290 / 60 / 20 / 50 / 2
serious
Total, serious adverse events
0 / 180 / 290 / 62 / 22 / 50 / 2

Outcome results

Primary

Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by Real World CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)

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.

Time frame: 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

ArmMeasureCategoryValue (COUNT_OF_UNITS)
Agreed to ParticipateFeasibility/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
Agreed to ParticipateFeasibility/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
Declined to ParticipateFeasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by Real World CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)# Not Adherent (< 3)0 Number of sessions rated for adherence
Declined to ParticipateFeasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by Real World CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)# Adherent (3 or above)6 Number of sessions rated for adherence
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by Real World CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)# Not Adherent (< 3)0 Number of sessions rated for adherence
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)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)2 Number of sessions rated for adherence
Primary

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)

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_UNITS)
Agreed to ParticipateFeasibility/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
Agreed to ParticipateFeasibility/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
Declined to ParticipateFeasibility/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)1 Number of sessions rated for adherence
Declined to ParticipateFeasibility/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)2 Number of sessions rated for adherence
Primary

Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm

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

Time frame: 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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Agreed to ParticipateFeasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 0 sessions0 Participants
Agreed to ParticipateFeasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 3-5 sessions1 Participants
Agreed to ParticipateFeasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 1-2 sessions2 Participants
Agreed to ParticipateFeasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 6 or more sessions2 Participants
Declined to ParticipateFeasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 3-5 sessions0 Participants
Declined to ParticipateFeasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 0 sessions2 Participants
Declined to ParticipateFeasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 1-2 sessions4 Participants
Declined to ParticipateFeasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 6 or more sessions3 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 1-2 sessions0 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 3-5 sessions0 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 0 sessions0 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 6 or more sessions0 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 0 sessions0 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 3-5 sessions0 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 1-2 sessions0 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 6 or more sessions1 Participants
Stage 2 DBT (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 0 sessions0 Participants
Stage 2 DBT (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 6 or more sessions2 Participants
Stage 2 DBT (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 1-2 sessions0 Participants
Stage 2 DBT (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 3-5 sessions0 Participants
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 3-5 sessions0 Participants
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 1-2 sessions0 Participants
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 0 sessions0 Participants
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each ArmAttended 6 or more sessions0 Participants
Primary

Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why

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

Time frame: 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).

ArmMeasureGroupValue (NUMBER)
Agreed to ParticipateFeasibility/Acceptability: Number of Students Who Declined to Participate in the Study and WhyDeclined when approached by counselor23 students
Agreed to ParticipateFeasibility/Acceptability: Number of Students Who Declined to Participate in the Study and WhyDeclined during the consenting process7 students
Agreed to ParticipateFeasibility/Acceptability: Number of Students Who Declined to Participate in the Study and WhyAgreed: Enrolled & Randomized in study62 students
Primary

Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies

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

Time frame: 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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Agreed to ParticipateFeasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesDropped5 Participants
Agreed to ParticipateFeasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesRetained13 Participants
Declined to ParticipateFeasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesDropped9 Participants
Declined to ParticipateFeasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesRetained20 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesDropped0 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesRetained6 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesDropped1 Participants
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesRetained1 Participants
Stage 2 DBT (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesRetained3 Participants
Stage 2 DBT (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesDropped2 Participants
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesDropped0 Participants
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment StrategiesRetained2 Participants
Primary

Feasibility/Acceptability: Participation Rate

Number of students approached who agreed to participate in the study

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Agreed to ParticipateFeasibility/Acceptability: Participation Rate18 Participants
Declined to ParticipateFeasibility/Acceptability: Participation Rate29 Participants
Primary

Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Agreed to ParticipateFeasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 127.54 score on a scaleStandard Deviation 3.99
Agreed to ParticipateFeasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 227.17 score on a scaleStandard Deviation 4.28
Declined to ParticipateFeasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 127.96 score on a scaleStandard Deviation 4.09
Declined to ParticipateFeasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 228.04 score on a scaleStandard Deviation 3.64
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 127.00 score on a scaleStandard Deviation 4
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 228.80 score on a scaleStandard Deviation 3.83
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 222.00 score on a scaleStandard Deviation 8.49
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 127.00 score on a scaleStandard Deviation 2.82
Stage 2 DBT (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 125.00 score on a scaleStandard Deviation 2.65
Stage 2 DBT (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 225.00 score on a scaleStandard Deviation 2
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 128.00 score on a scaleStandard Deviation 4.24
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)Stage 232.00 score on a scaleStandard Deviation 0
Primary

Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)

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).

Time frame: 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).

ArmMeasureGroupValue (MEAN)Dispersion
Agreed to ParticipateFeasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 126.83 score on a scaleStandard Deviation 4.38
Agreed to ParticipateFeasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 224.59 score on a scaleStandard Deviation 6
Declined to ParticipateFeasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 225.00 score on a scaleStandard Deviation 6.4
Declined to ParticipateFeasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 125.18 score on a scaleStandard Deviation 6.51
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 123.33 score on a scaleStandard Deviation 5.39
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 225.25 score on a scaleStandard Deviation 2.5
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 223.00 score on a scaleStandard Deviation 5.66
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 121.50 score on a scaleStandard Deviation 2.12
Stage 2 DBT (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 121.80 score on a scaleStandard Deviation 4.6
Stage 2 DBT (Didn't Respond to Stage 1 TAU)Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 223.50 score on a scaleStandard Deviation 3.11
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 230.00 score on a scaleโ€”
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)Stage 122.00 score on a scaleStandard Deviation 2.83
Secondary

Scale for Suicide Ideation-Current (SSI)

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Agreed to ParticipateScale for Suicide Ideation-Current (SSI)Baseline13.72 score on a scaleStandard Deviation 7.07
Agreed to ParticipateScale for Suicide Ideation-Current (SSI)S1 (end of Phase I interventions) -8 weeks7.35 score on a scaleStandard Deviation 6.45
Declined to ParticipateScale for Suicide Ideation-Current (SSI)Baseline13.79 score on a scaleStandard Deviation 5.13
Declined to ParticipateScale for Suicide Ideation-Current (SSI)S1 (end of Phase I interventions) -8 weeks5.66 score on a scaleStandard Deviation 6.44
Comparison: Due to the large number of zeroes in the Suicidal Ideation (SI)-Current Subscale of the SSI at post (over a third of the participants reported no SI at the end of treatment), a zero-altered model was utilized which divided the outcome into (1) the probability of any SI and (2) the intensity of SI when non-zero, as done in other studies. This analysis tested the difference between the CAMS and TAU arms based on number of participants reporting no SI post Stage 1 treatment.p-value: 0.1995% CI: [-2.41, 15.35]Chi-squared
Other Pre-specified

The Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.

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

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Agreed to ParticipateThe Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.Baseline1.98 score on a scaleStandard Deviation 1.06
Agreed to ParticipateThe Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.Stage 11.70 score on a scaleStandard Deviation 0.9
Declined to ParticipateThe Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.Stage 11.42 score on a scaleStandard Deviation 1.7
Declined to ParticipateThe Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.Baseline2.23 score on a scaleStandard Deviation 0.99
p-value: 0.03595% CI: [0.04, 1.05]t-test, 2 sided
Other Pre-specified

The Suicide Attempt and Self-Injury Count (SASI-C)

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Agreed to ParticipateThe Suicide Attempt and Self-Injury Count (SASI-C)Baseline : SASI-C (1 or more self-inflicted injuries)24 Participants
Agreed to ParticipateThe Suicide Attempt and Self-Injury Count (SASI-C)Baseline : SASI-C (endorsed suicide attempt in last 2 month)7 Participants
Agreed to ParticipateThe Suicide Attempt and Self-Injury Count (SASI-C)Post Stage 1 : SASI-C (endorsed suicide attempt in last 2 months)0 Participants
Agreed to ParticipateThe Suicide Attempt and Self-Injury Count (SASI-C)Post Stage 1 : SASI-C (1 or more self-inflicted injuries)9 Participants
Declined to ParticipateThe Suicide Attempt and Self-Injury Count (SASI-C)Post Stage 1 : SASI-C (1 or more self-inflicted injuries)7 Participants
Declined to ParticipateThe Suicide Attempt and Self-Injury Count (SASI-C)Baseline : SASI-C (endorsed suicide attempt in last 2 month)3 Participants
Declined to ParticipateThe Suicide Attempt and Self-Injury Count (SASI-C)Baseline : SASI-C (1 or more self-inflicted injuries)26 Participants
Declined to ParticipateThe Suicide Attempt and Self-Injury Count (SASI-C)Post Stage 1 : SASI-C (endorsed suicide attempt in last 2 months)0 Participants
p-value: 0.25Regression, Logistic

Source: ClinicalTrials.gov ยท Data processed: Feb 4, 2026