Developing and Implementing an Adolescent Suicide Prevention Program in a Community Mental Health Setting

March 25, 2021 updated by: Beth Kennard, University of Texas Southwestern Medical Center
This is a three phase study to develop and implement an adolescent suicide prevention program in a community mental health setting. In Phase 1, needs assessments using qualitative interviews will be conducted at in a community mental health clinic with suicidal teens and their parents, and with community experts including therapy staff who serve patients at a community mental health clinic. In Phase 2, the investigators will develop a new treatment manual that is guided by information obtained in the previously completed needs assessment. The investigators will pilot the program with one group of adolescents (N=10), and make iterative revisions based on feedback. Training sessions will be implemented. In Phase 3, the investigators will conduct an open trial of a group for 40 adolescents at the community mental health clinic to assess feasibility of recruitment, implementation, satisfaction, and outcome. Program outcomes will be utilization, patient and family satisfaction ratings, and improvement in depression and suicide risk measures at discharge from the program and at one month and six months follow-up. In addition, rate of suicidal events (suicide attempt, hospitalization) at one month and six months post-discharge will be compared to historical controls.

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

In Phase 1, the investigators will develop interviews and data collection guides. The investigators will interview 10 current patients and parents at a community mental health clinic (for a total of 20 individuals). The investigators will elicit respondent perspectives relating to: (a) utilization of care (b) treatment targets (c); parent/family participation and (d) session format. Also, as part of Phase 1, the investigators will conduct interviews with the 8 treatment providers at a community mental health clinic. In addition to exploring the content of treatment modules of the intensive outpatient program (IOP) program, the investigators will share responses from patients and parents, and will solicit provider feedback regarding those responses. Building on patient-reported needs, the investigators will solicit provider expectations, requisite elements and other concerns regarding implementation of an intensive treatment program in community mental health clinic settings. Coders will independently read the transcripts and code for common elements. Developing a codebook to document procedures, the investigators will compare and contrast codes and respective quotations across respondents. Coding discrepancies will be discussed and conflicts between raters resolved using a third investigator. The investigators will present the preliminary manual content to clinician respondents to explore feasibility of the proposed intervention. Data will be coded and analyzed using standard qualitative approaches and will guide the manual development and intervention components to be used in Phases 2 and 3.

In Phase 2, the investigators will incorporate responses into a draft of treatment manual, and train a group of community mental health clinic staff to deliver treatment. The investigators will test this adapted manual with an open trial to test feasibility and piloting of the intervention and outcome measures. Patients and parents will complete the Quick Inventory of Depressive Symptomatology - Adolescents (QIDS-A). Client Satisfaction Questionnaire (CSQ) will be obtained at discharge. Participants will complete the Interpersonal Needs Questionnaire (INQ), Concise Health Risk Tracking (CHRT) , and the Acquired Capability for Suicide Scale (ACSS) at both intake and discharge, Clinicians will complete the Clinician Checklist and the Columbia Suicide Severity Rating Scale (C-SSRS) at baseline and discharge. The investigators will conduct exit interviews completed with both the parent and patient, to assess the acceptability of treatment. The investigators will obtain feedback about perceived effectiveness of the treatment, the appropriateness of treatment targets, identification of other targets or approaches that would have been more helpful, and barriers to participation. The investigators will obtain similar feedback from the treating clinicians. Based on patient, family, and clinician feedback, a satisfaction questionnaire (patient and parent), and outcome data from the open trial, the manual, treatment program structure can be modified in Phase 3 to improve feasibility and acceptability. The investigators will collect follow-up information at 1 month and 6 months following the patient's final session.

In Phase 3, participants will be 40 adolescents who present to the community mental health clinic with a recent suicide attempt or significant suicidal ideation with a plan or intent. Participants must be English-speaking, although parents must be able to speak Spanish. Participants can have unipolar or bipolar disorder, conduct or oppositional disorder, eating disorder, or alcohol or substance use or abuse, all of which are common comorbidities in the suicidal adolescent sample. Excluded are those with current psychosis, mania, alcohol or substance dependence, autism spectrum disorders, <80% of ideal body weight, or low intelligence quotient (IQ) based on clinical judgement (if concerns about intellectual capabilities are evident at assessment), as these conditions may require more intensive interventions or limit comprehension of the intervention components. The program will include 1-2 hours of group therapy once weekly, and utilize Cognitive Behavioral Therapy and Dialectical Behavior Therapy components focusing on skills to reduce risk factors associated with suicidal behaviors. The selection and emphasis on specific skills will be based on input during the early phases of the project. Length of treatment is expected to be 6-8 weeks, depending on individual patient need. Adolescents also will receive individual and/or family therapy, and will be referred to a psychiatrist for medication management as needed. In addition, parents will attend a 1-hour biweekly skills-based parent group.

Outcome Measures. Patients and parents will complete the Quick Inventory of Depressive Symptomatology - Adolescents (QIDS-A). Client Satisfaction Questionnaire (CSQ) will be obtained at discharge. Participants will complete the Interpersonal Needs Questionnaire (INQ), Concise Health Risk Tracking (CHRT), and the Acquired Capability for Suicide Scale (ACSS) at both intake and discharge, Clinicians will complete the Clinician Checklist and the Columbia Suicide Severity Rating Scale (C-SSRS) at baseline and discharge. The investigators will collect follow-up information at 1 month and 6 months following each patient's final session.

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.
102

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
    • Texas
      • Dallas, Texas, United States, 75247
        • Metrocare Services

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

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Self-identifying Latino/Latina adolescents (aged 12-17 years) currently in outpatient treatment at Metrocare and who struggle with depression and/or suicidal ideations
  • Adolescents must speak English fluently as the self-report forms do not have normative data for non-English speaking subjects, and the confidential nature of therapy prevents us from being able to use a translator for visits. Parents of participants may speak Spanish or English.

Exclusion Criteria:

  • current psychosis
  • mania
  • alcohol or substance dependence
  • autism spectrum disorders
  • <80% of ideal body weight
  • IQ<70 (based on clinical judgement)

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
No Intervention: Qualitative Interviews
Qualitative Interviews with adolescents, their parents and clinicians.
Experimental: Open Pilot
Open-label pilot group of adolescents (n=10) in a suicide prevention intensive outpatient program
Behavioral: Suicide Prevention Intensive Outpatient Program
participation in a suicide prevention intensive outpatient program
Experimental: Open-label trial
Open-label trial of adolescents (n=40) in a suicide prevention intensive outpatient program
Behavioral: Suicide Prevention Intensive Outpatient Program
participation in a suicide prevention intensive outpatient program

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
Quick Inventory of Depressive Symptomatology - Adolescents (QIDS-A)
Time Frame: through program completion, an average of 6 weeks
measure of depression symptom severity, total range = 0-27, lower values are considered to be better (less depressed) than higher values (which indicate more depressed). Lower scores indicate a better outcome than higher scores. No subscales.
through program completion, an average of 6 weeks
Concise Health Risk Tracking (CHRT)
Time Frame: through program completion, an average of 6 weeks
measure of suicide propensity and risk
through program completion, an average of 6 weeks
Client Satisfaction Questionnaire (CSQ)
Time Frame: at program completion, on average 6 weeks after program completion
measure of client satisfaction
at program completion, on average 6 weeks after program completion
Follow-up Interview
Time Frame: one-month after program completion
to assess subsequent suicidal behaviors, service utilization, and ongoing psychiatric and psychosocial treatment adherence
one-month after program completion

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 Texas Southwestern Medical Center

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: Beth D. Kennard, PsyD, UT Southwestern Medical Center

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.
August 1, 2016

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.
August 31, 2020

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 31, 2020

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).
January 2, 2019

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.
June 18, 2019

First Posted (Actual)

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.
June 20, 2019

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 30, 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.
March 25, 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.
March 1, 2021

More Information

Terms related to this study

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.
  • STU 112016-061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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