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

Primary Purpose

Suicide, Attempted, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suicide Prevention Intensive Outpatient Program
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Suicide, Attempted

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Metrocare Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Qualitative Interviews

Open Pilot

Open-label trial

Arm Description

Qualitative Interviews with adolescents, their parents and clinicians.

Open-label pilot group of adolescents (n=10) in a suicide prevention intensive outpatient program

Open-label trial of adolescents (n=40) in a suicide prevention intensive outpatient program

Outcomes

Primary Outcome Measures

Quick Inventory of Depressive Symptomatology - Adolescents (QIDS-A)
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.
Concise Health Risk Tracking (CHRT)
measure of suicide propensity and risk
Client Satisfaction Questionnaire (CSQ)
measure of client satisfaction
Follow-up Interview
to assess subsequent suicidal behaviors, service utilization, and ongoing psychiatric and psychosocial treatment adherence

Secondary Outcome Measures

Full Information

First Posted
January 2, 2019
Last Updated
March 25, 2021
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03992391
Brief Title
Developing and Implementing an Adolescent Suicide Prevention Program in a Community Mental Health Setting
Official Title
Developing and Implementing an Adolescent Suicide Prevention Program in a Community Mental Health Setting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicidal Ideation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Phase 1: Treatment Development Phase 2: Pilot Group Phase 3: Open Trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Qualitative Interviews
Arm Type
No Intervention
Arm Description
Qualitative Interviews with adolescents, their parents and clinicians.
Arm Title
Open Pilot
Arm Type
Experimental
Arm Description
Open-label pilot group of adolescents (n=10) in a suicide prevention intensive outpatient program
Arm Title
Open-label trial
Arm Type
Experimental
Arm Description
Open-label trial of adolescents (n=40) in a suicide prevention intensive outpatient program
Intervention Type
Behavioral
Intervention Name(s)
Suicide Prevention Intensive Outpatient Program
Intervention Description
participation in a suicide prevention intensive outpatient program
Primary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Adolescents (QIDS-A)
Description
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.
Time Frame
through program completion, an average of 6 weeks
Title
Concise Health Risk Tracking (CHRT)
Description
measure of suicide propensity and risk
Time Frame
through program completion, an average of 6 weeks
Title
Client Satisfaction Questionnaire (CSQ)
Description
measure of client satisfaction
Time Frame
at program completion, on average 6 weeks after program completion
Title
Follow-up Interview
Description
to assess subsequent suicidal behaviors, service utilization, and ongoing psychiatric and psychosocial treatment adherence
Time Frame
one-month after program completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth D. Kennard, PsyD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metrocare Services
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States

12. IPD Sharing Statement

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

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