Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART (SMART)

February 9, 2021 updated by: University of Nevada, Reno
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Reno, Nevada, United States, 89557
        • Counseling Services, University of Nevada, Reno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stage 1 TAU plus Stage 2 CAMS

Treatment as usual [TAU] -- the treatment typically provided by the counselor for 4-8 weeks

If participant is responding, treatment ends. Participants who don't respond are then re-randomized to

Collaborative Assessment and Management of Suicidality (CAMS) for 4-16 weeks
Behavioral: Stage 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.
Behavioral: Stage 2 CAMS
4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
Experimental: Stage 1 TAU plus Stage 2 DBT

Treatment as usual [TAU] -- the treatment typically provided by the counselor for 4-8 weeks

If participant is responding, treatment ends. Participants who don't respond are then re-randomized to

Dialectical Behavioral Therapy (DBT) for 4-16 weeks
Behavioral: Stage 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.
Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)
4-16 weeks of Dialectical Behavioral Therapy (DBT)
Experimental: Stage 1 CAMS plus Stage 2 CAMS

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

If participant is responding, treatment ends. Participants who don't respond are then re-randomized to

Additional Collaborative Assessment and Management of Suicidality (CAMS) for 4-16 weeks
Behavioral: Stage 2 CAMS
4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
Behavioral: Stage 1 CAMS
4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
Experimental: Stage 1 CAMS plus Stage 2 DBT

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

If participant is responding, treatment ends. Participants who don't respond are then re-randomized to

Dialectical Behavioral Therapy (DBT) for 4-16 weeks
Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)
4-16 weeks of Dialectical Behavioral Therapy (DBT)
Behavioral: Stage 1 CAMS
4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility/Acceptability: Participation Rate
Time Frame: Baseline
Number of students approached who agreed to participate in the study
Baseline
Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why
Time Frame: Baseline
Two typologies as to when students declined to participate emerged: Declined when approached, and Declined during the consenting process.
Baseline
Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies
Time Frame: After Stage 2
Feasibility/Acceptability (Treatment Retention): Number of students who were retained within each of the four Adaptive Treatment Strategies
After Stage 2
Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm
Time Frame: Throughout 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
Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)
Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by "Real World" CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)
Time Frame: 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.
Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)
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)
Time Frame: 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.
During Stage 2 (sessions 9 through 24 of treatment)
Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 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).
End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)
Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)
Time Frame: 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).
End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Scale for Suicide Ideation-Current (SSI)
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
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.
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Suicide Attempt and Self-Injury Count (SASI-C)
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).
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.
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 Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.
Time Frame: Baseline and End of Stage 1 interventions - 8 weeks after baseline
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
Baseline and End of Stage 1 interventions - 8 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nevada, Reno

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
The Catholic University of America

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacqueline Pistorello, PhD, University of Nevada, Reno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 603856
  • R34MH104714 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After study is complete and data analyzed, interested researchers can contact the PI for data inquiries. Only de-identified data will be released to qualified researchers.

IPD Sharing Time Frame

July 2018 to July 2022

IPD Sharing Access Criteria

  1. Researcher contacts PI at pistorel@unr.edu
  2. There is justification for the use of the data and this is deemed appropriate by the PI and institution representative

IPD Sharing Supporting Information Type

  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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