N/A
N=84
CAMPUS - Feasibility Sub-Study
Suicide
Bottom Line
View on ClinicalTrials.gov: NCT04728815 ↗Enrolled (actual)
84
Serious AEs
8.3%
Results posted
Feb 2024
Primary outcome: Primary: Number of Eligible Students Who Agree to Randomization — 8; 24; 20; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TAU - Phase 1 (Behavioral); CAMS - Phase 1 (Behavioral); DBT - Phase 1 and 2 (Behavioral); CAMS - Phase 2 (Behavioral); DBT - Phase 2 (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eligible Students Who Agree to Randomization |
8; 24; 20; 16 | — |
| PRIMARY Counselor Recruitment |
4; 4; 4; 4 | — |
| PRIMARY Treatment Adherence as Measured by DBT (Dialectical Behavior Therapy) Adherence Rating Scale |
3.5; 3.68; 3.72; 3.81 | — |
| PRIMARY Treatment Adherence as Measured by CAMS (Collaborative Assessment and Management of Suicidality) Adherence Rating Scale |
4.05; 4.66; 4.45; 4.77 | — |
| PRIMARY Number of Sessions Attended by Students in Each Treatment Condition |
5.75; 5.75; 9.10; 6.00; 7.29; 7.00 | — |
| PRIMARY Number of Students Who Attrite From the Study (by Withdrawing Early From Treatment or Dropping Out of the Trial) |
0; 5; 4; 0; 3; 1 | — |
| PRIMARY Student Treatment Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ) |
3.5; 3.4; 3.0; 3.83; 3.17; 3.31 | — |
| PRIMARY Counselor Training Satisfaction |
4.48; 4.70 | — |
| PRIMARY Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ) |
3.46; 2.96; 2.92; 3.56; 2.79; 2.88 | — |
| PRIMARY Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ) |
2.88; 2.90; 3.00; 3.24 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Enrolled at the university;
- 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).
- 18 to 25 years of age;
- 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
- Agree to video recording of all therapy and assessment sessions.
Exclusion Criteria
- 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);
- Students being unable to remain enrolled in their university long enough to go through the minimum number of sessions for Stage 1 (4 sessions);
- Students who have received services at the CCC within the last three months (i.e., ATSs must be based on a new treatment episode).
Data sourced from ClinicalTrials.gov (NCT04728815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.