Suicide, AttemptedNCT03992391
Developing and Implementing an Adolescent Suicide Prevention Program in a Community Mental Health Setting
A study testing Suicide Prevention Intensive Outpatient Program in people with Suicide, Attempted and Suicidal Ideation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Suicide Prevention Intensive Outpatient Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- current psychosis
- mania
- alcohol or substance dependence
- autism spectrum disorders
- <80% of ideal body weight
- IQ<70 (based on clinical judgement)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Being tested
- Suicide Prevention Intensive Outpatient Program
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide Prevention Intensive Outpatient ProgramBehavioural
participation in a suicide prevention intensive outpatient program
| Study group | Role | What they receive |
|---|---|---|
| Qualitative Interviews | No intervention | Qualitative Interviews with adolescents, their parents and clinicians. |
| Open Pilot | Experimental | Open-label pilot group of adolescents (n=10) in a suicide prevention intensive outpatient program Receives: Behavioral: Suicide Prevention Intensive Outpatient Program |
| Open-label trial | Experimental | Open-label trial of adolescents (n=40) in a suicide prevention intensive outpatient program Receives: Behavioral: Suicide Prevention Intensive Outpatient Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through program completion, an average of 6 weeks
Concise Health Risk Tracking (CHRT)
measure of suicide propensity and risk
Measured: through program completion, an average of 6 weeks
Client Satisfaction Questionnaire (CSQ)
measure of client satisfaction
Measured: at program completion, on average 6 weeks after program completion
Follow-up Interview
to assess subsequent suicidal behaviors, service utilization, and ongoing psychiatric and psychosocial treatment adherence
Measured: one-month after program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Aug 2016
- Primary completion31 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Phase 1: Treatment Development Phase 2: Pilot Group Phase 3: Open Trial
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Kennard, University of Texas Southwestern Medical Center
- Investigators
- Beth D. Kennard, PsyD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992391
- Sponsor's protocol ID
- STU 112016-061
- Status last verified
- Mar 2021
- First submitted
- 2 Jan 2019
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Implementing an Adolescent Suicide Prevention Program in a Community Mental Health Setting
- ClinicalTrials.gov ID
- NCT03992391
- Acronym / sponsor ID
- STU 112016-061
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1: Treatment Development Phase 2: Pilot Group Phase 3: Open Trial
| Arm | Type | Receives |
|---|---|---|
| Qualitative Interviews | No intervention | –Qualitative Interviews with adolescents, their parents and clinicians. |
| Open Pilot | Experimental | Behavioral: Suicide Prevention Intensive Outpatient ProgramOpen-label pilot group of adolescents (n=10) in a suicide prevention intensive outpatient program |
| Open-label trial | Experimental | Behavioral: Suicide Prevention Intensive Outpatient ProgramOpen-label trial of adolescents (n=40) in a suicide prevention intensive outpatient program |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- current psychosis
- mania
- alcohol or substance dependence
- autism spectrum disorders
- <80% of ideal body weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suicide Prevention Intensive Outpatient Programparticipation in a suicide prevention intensive outpatient program | Behavioural | Open Pilot, Open-label trial |
Primary outcome
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.
Concise Health Risk Tracking (CHRT)
Time frame: through program completion, an average of 6 weeks
measure of suicide propensity and risk
Client Satisfaction Questionnaire (CSQ)
Time frame: at program completion, on average 6 weeks after program completion
measure of client satisfaction
Follow-up Interview
Time frame: one-month after program completion
to assess subsequent suicidal behaviors, service utilization, and ongoing psychiatric and psychosocial treatment adherence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
Related trials for Suicide, Attempted
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Recruiting
Suicide Preventive Psychosocial Treatment for Youths
Suicide Attempt, Suicidal and Self-injurious Behavior
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
Suicide
Active, not recruiting
DBT Skills Groups for Veterans at High Risk for Suicide Attempt
Suicide, Attempted
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth D. Kennard, PsyD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suicide Prevention Intensive Outpatient Program in people with Suicide, Attempted and Suicidal Ideation, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depressive Symptomatology - Adolescents (QIDS-A) (time frame: through program completion, an average of 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.