CAMPUS - Feasibility Sub-Study

Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS) - Feasibility Sub-Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04728815

Acronym

CAMPUS-Feas

Enrollment

Registered

2021-01-28

Start date

2021-01-04

Completion date

2022-10-15

Last updated

2024-02-29

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

Conditions

Suicide

Keywords

Dialectical Behavior Therapy (DBT), Collaborative Assessment and Management of Suicide (CAMS), University Students

Brief summary

Suicide is the 2nd leading cause of death among college students and suicidal ideation and suicide-related behaviors are a frequent presenting problem at college counseling centers (CCCs), which are overburdened. Studies show that some students respond rapidly to treatment, whereas others require considerably more resources. Evidence-based adaptive treatment strategies (ATSs) are needed to address this heterogeneity in responsivity and complexity. ATSs individualize treatment via decision rules specifying how the type and intensity of an intervention can be sequenced based on risk factors, response, or compliance. The purpose of this multisite study is to investigate the effectiveness of four adaptive treatment strategies (ATSs) to treat college students who report suicidal ideation when first seeking services at their college counseling center This multisite study will enroll moderately to severely suicidal college students in the emerging adulthood phase (ages 18-25) seeking services at CCCs. This Sequential Multi-Assignment Randomized Trial (SMART) will have two stages of intervention. In Stage 1, 700 participants from four CCCs will be randomized to 4-8 weeks of: 1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) or 2) Treatment as Usual (TAU). Sufficient responders to either intervention will discontinue services/be stepped down. Non-responders will be re-randomized to one of two Stage 2 higher intensity/dosage intervention options for an additional 4-16 weeks: 1) CAMS (either continued or administered for the first time) or 2) Comprehensive Dialectical Behavior Therapy (DBT), which includes individual therapy, skills group, and phone/text coaching for the clients and peer consultation for the counselors.

Detailed description

We will enroll moderately to severely suicidal college students in the emerging adulthood phase (ages 18-25) seeking services at CCCs. Eighty-Five participants (N=85) from four CCCs will be randomized to one of three treatments delivered via a hybrid model: (1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks (n=35); (2) Treatment as Usual (TAU) for 4-8 weeks (n=15); or (3) Comprehensive Dialectical Behavior Therapy (DBT) for 16 weeks (n=35), which includes individual therapy, skills training, phone/text coaching for the clients, and peer consultation for the counselors. Sufficient responders to CAMS or TAU will discontinue services/be stepped down after 4-8 weeks. Non-responders to CAMS or TAU will be re-randomized to one of two higher intensity/dosage intervention options for an additional 8 weeks of treatment: (1) CAMS (either continued or administered for the first time) or (2) Comprehensive DBT. For the feasibility study, we will also enroll 12 CCC counselors (3 per site) who will serve as study counselor participants and periodically complete measures focused on the experience of counselors working with suicidal college students.

Interventions

BEHAVIORALTAU - Phase 1

4-8 weeks of TAU treatment

BEHAVIORALCAMS - Phase 1

4-8 weeks of CAMS treatment

BEHAVIORALDBT - Phase 1 and 2

up to 16 weeks of DBT treatment

BEHAVIORALCAMS - Phase 2

Up to 8 weeks of CAMS treatment

BEHAVIORALDBT - Phase 2

Up to 8 weeks of DBT treatment

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Participants will be randomized to one of three treatments delivered via a hybrid model: (1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks (n=35); (2) Treatment as Usual (TAU) for 4-8 weeks (n=15); or (3) Comprehensive Dialectical Behavior Therapy (DBT) for 16 weeks (n=35), which includes individual therapy, skills training, phone/text coaching for the clients, and peer consultation for the counselors. Sufficient responders to CAMS or TAU will discontinue services/be stepped down after 4-8 weeks. Non-responders to CAMS or TAU will be re-randomized to one of two higher intensity/dosage intervention options for an additional 8 weeks of treatment: (1) CAMS (either continued or administered for the first time) or (2) Comprehensive DBT. There is an 8th Arm/Group of Consented Study Counselors from each of the 4 sites.

Eligibility

Sex/Gender

ALL

Age

18 Years to 25 Years

Healthy volunteers

Inclusion criteria

1. Enrolled at the university; 2. Eligible to receive counseling services either in person or remotely at the campus CCC (e.g., some students who are living in specific states may not be eligible for therapeutic services). 3. 18 to 25 years of age; 4. Moderate to severe SI over the last two weeks indicated by a score of greater than or equal to 2 on the Counseling Center Assessment of Psychological Symptoms (CCAPS-34) question, I have thoughts of ending my life (range is 0 not at all like me to 4 extremely like me); and 5. Agree to video recording of all therapy and assessment sessions.

Exclusion criteria

1. Students who are deemed clinically inappropriate to receive services at the CCC by an intake counselor because of imminent risk, severe psychosis, or inability to remain enrolled in school (e.g., academic failure); 2. Students being unable to remain enrolled in their university long enough to go through the minimum number of sessions for Stage 1 (4 sessions); 3. Students who have received services at the CCC within the last three months (i.e., ATSs must be based on a new treatment episode).

Design outcomes

Primary

Measure	Time frame	Description
Number of Eligible Students Who Agree to Randomization	To the end of initial Randomization (up to 1 week)	Among students who are eligible to participate in the study and approached about the study by an intake worker, the number who agree to randomization to one of three treatments will be reported.
Counselor Recruitment	To the end of initial counselor recruitment (up to 2 weeks)	Among the counselors eligible to participate in the study, the number of counselors from each site who agree to participate.
Treatment Adherence as Measured by DBT (Dialectical Behavior Therapy) Adherence Rating Scale	To the end of treatment period (up to 16 weeks)	Existing gold-standard adherence instruments for DBT will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. Each item is rated on a scale where 0 = not used/not necessary, 1-3 = below adherence, 4 = minimum threshold for adherence, and 5 = adherent with high sufficiency. The DBT ACS is scored by averaging all non-zero items to create a computed global score where 3.8 and higher is considered adherent.
Treatment Adherence as Measured by CAMS (Collaborative Assessment and Management of Suicidality) Adherence Rating Scale	To the end of treatment period (up to 16 weeks)	Existing gold-standard adherence instruments for CAMS will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. The measure consists of 14 items evaluating clinician performance, all rated on a seven-point Likert scale ranging from 0 (Poor) to 6 (Excellent). A session is rated as adherent with a score of 3.5 or greater.
Number of Sessions Attended by Students in Each Treatment Condition	To the end of treatment period (up to 16 weeks)	—
Number of Students Who Attrite From the Study (by Withdrawing Early From Treatment or Dropping Out of the Trial)	To the end of treatment period (up to 16 weeks)	—
Student Treatment Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)	To the end of treatment period (up to 16 weeks)	CSQ items are rated from 1-4, with higher scores reflecting greater satisfaction.
Counselor Training Satisfaction	To end of initial training period (up to 4 weeks)	An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the Continuing Education Unit (CEU) evaluation surveys for the CAMS (Collaborative Assessment and Management of Suicidality) and DBT (Dialectical Behavior Therapy) online trainings. Item scores range from 1 (Not at all valuable) to 5 (Extremely valuable).
Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	To the end of stage 1 (up to 8 weeks)	An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment.
Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	Beginning to end of Stage 2 (up to 8 weeks)	An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment.

Countries

United States

Participant flow

Recruitment details

College students seeking treatment at college counseling center. Eligible students endorsed suicidal thoughts at intake.

Pre-assignment details

While they were consented to assure they fully understood the rights and responsibilities of their study role, data about Study Counselors is not collected as it is for the Student Participants. Per CT.gov request, they are however being included as a separate 8th Arm/Group for purposes of this data reporting.

Participants by arm

Arm	Count
CAMS to Maintenance Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring. CAMS - Phase 1: 4-8 weeks of CAMS treatment	12
CAMS to CAMS Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS. CAMS - Phase 1: 4-8 weeks of CAMS treatment CAMS - Phase 2: Up to 8 weeks of CAMS treatment	8
CAMS to DBT Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT. CAMS - Phase 1: 4-8 weeks of CAMS treatment DBT - Phase 2: Up to 8 weeks of DBT treatment	10
TAU to Maintenance Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring. TAU - Phase 1: 4-8 weeks of TAU treatment	4
TAU to CAMS Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS. TAU - Phase 1: 4-8 weeks of TAU treatment CAMS - Phase 2: Up to 8 weeks of CAMS treatment	7
TAU to DBT Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT. TAU - Phase 1: 4-8 weeks of TAU treatment DBT - Phase 2: Up to 8 weeks of DBT treatment	1
DBT Only Subject Assigned to DBT for Phase 1, continuing up to 16 weeks. DBT - Phase 1 and 2: up to 16 weeks of DBT treatment	26
Study Counselors Consented Study Counselors from each of the 4 sites. Data collected regarding the Counselors is minimal and is maintained completely separately from the other 7 Student Participant Arms/Groups.	16
Total	84

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006
Overall Study	Lost to Follow-up	3	0	0	1	1	0	2
Overall Study	Physician Decision	0	0	1	0	0	0	0
Overall Study	Study drop	0	3	3	0	0	0	7
Overall Study	Treatment drop	0	2	1	0	3	1	3

Baseline characteristics

Characteristic	CAMS to Maintenance	CAMS to CAMS	CAMS to DBT	TAU to Maintenance	TAU to CAMS	TAU to DBT	DBT Only	Study Counselors	Total
Age, Continuous	21.08 years STANDARD_DEVIATION 2.19	20.37 years STANDARD_DEVIATION 2.07	20.90 years STANDARD_DEVIATION 2.38	19.25 years STANDARD_DEVIATION 1.26	19.86 years STANDARD_DEVIATION 1.34	20.00 years STANDARD_DEVIATION 8	19.88 years STANDARD_DEVIATION 2.05	37.38 years STANDARD_DEVIATION 9.05	20.26 years STANDARD_DEVIATION 2.03
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants	6 Participants	8 Participants	3 Participants	5 Participants	1 Participants	17 Participants	1 Participants	50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants	2 Participants	2 Participants	1 Participants	2 Participants	0 Participants	9 Participants	15 Participants	34 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants	3 Participants	4 Participants	13 Participants
Race (NIH/OMB) Black or African American	4 Participants	2 Participants	2 Participants	1 Participants	1 Participants	1 Participants	3 Participants	2 Participants	16 Participants
Race (NIH/OMB) More than one race	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	4 Participants	2 Participants	11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	4 Participants
Race (NIH/OMB) White	3 Participants	3 Participants	5 Participants	3 Participants	2 Participants	0 Participants	14 Participants	7 Participants	37 Participants
Region of Enrollment United States	12 Participants	8 Participants	10 Participants	4 Participants	7 Participants	1 Participants	26 Participants	16 Participants	84 Participants
Sex: Female, Male Female	8 Participants	5 Participants	8 Participants	4 Participants	5 Participants	1 Participants	16 Participants	13 Participants	60 Participants
Sex: Female, Male Male	4 Participants	3 Participants	2 Participants	0 Participants	2 Participants	0 Participants	10 Participants	3 Participants	24 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 5	0 / 9	0 / 4	0 / 7	0 / 1	0 / 26	0 / 30	0 / 12
other Total, other adverse events	0 / 12	0 / 5	1 / 9	0 / 4	0 / 7	0 / 1	3 / 26	9 / 30	3 / 12
serious Total, serious adverse events	0 / 12	0 / 8	0 / 9	0 / 4	0 / 7	0 / 1	4 / 26	4 / 30	1 / 12

Outcome results

Primary

Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)

An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment.

Time frame: To the end of stage 1 (up to 8 weeks)

Population: Participants who completed Stage 1 of treatment.

Arm	Measure	Value (MEAN)
Duke University	Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	3.46 score on a scale
Rutgers University	Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	2.96 score on a scale
University of Nevada, Reno	Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	2.92 score on a scale
University of Oregon	Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	3.56 score on a scale
TAU to CAMS	Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	2.79 score on a scale
TAU to DBT	Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	2.88 score on a scale
DBT Only	Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	2.96 score on a scale

Primary

Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)

Time frame: Beginning to end of Stage 2 (up to 8 weeks)

Population: Participants who completed Stage 2 of treatment.

Arm	Measure	Value (MEAN)
Rutgers University	Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	2.88 score on a scale
University of Nevada, Reno	Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	2.90 score on a scale
TAU to CAMS	Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	3.00 score on a scale
DBT Only	Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)	3.24 score on a scale

Primary

Counselor Recruitment

Among the counselors eligible to participate in the study, the number of counselors from each site who agree to participate.

Time frame: To the end of initial counselor recruitment (up to 2 weeks)

Population: Counselors meeting all inclusion criteria and no exclusion criteria.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Duke University	Counselor Recruitment	4 Participants
Rutgers University	Counselor Recruitment	4 Participants
University of Nevada, Reno	Counselor Recruitment	4 Participants
University of Oregon	Counselor Recruitment	4 Participants

Primary

Counselor Training Satisfaction

An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the Continuing Education Unit (CEU) evaluation surveys for the CAMS (Collaborative Assessment and Management of Suicidality) and DBT (Dialectical Behavior Therapy) online trainings. Item scores range from 1 (Not at all valuable) to 5 (Extremely valuable).

Time frame: To end of initial training period (up to 4 weeks)

Population: We had 16 total consented counselors, and 2 entire rounds of DBT training, which some attended twice. 8 counselors attended both (8x2=16), while 4 others attended Round 1 only and another 4 attended Round 2 only. Therefore, a total of 24 DBT training ratings for 16 counselors. Ten counselors attended one CAMS session each.

Arm	Measure	Value (MEAN)
Duke University	Counselor Training Satisfaction	4.48 score on a scale
Rutgers University	Counselor Training Satisfaction	4.70 score on a scale

Primary

Number of Eligible Students Who Agree to Randomization

Among students who are eligible to participate in the study and approached about the study by an intake worker, the number who agree to randomization to one of three treatments will be reported.

Time frame: To the end of initial Randomization (up to 1 week)

Population: Students meeting all inclusion criteria and no exclusion criteria.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Duke University	Number of Eligible Students Who Agree to Randomization	8 Participants
Rutgers University	Number of Eligible Students Who Agree to Randomization	24 Participants
University of Nevada, Reno	Number of Eligible Students Who Agree to Randomization	20 Participants
University of Oregon	Number of Eligible Students Who Agree to Randomization	16 Participants

Primary