NCT03992391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

4.1 years

First QC Date

January 2, 2019

Last Update Submit

March 25, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    through program completion, an average of 6 weeks

  • Concise Health Risk Tracking (CHRT)

    measure of suicide propensity and risk

    through program completion, an average of 6 weeks

  • Client Satisfaction Questionnaire (CSQ)

    measure of client satisfaction

    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

    one-month after program completion

Study Arms (3)

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

Behavioral: Suicide Prevention Intensive Outpatient Program

Open-label trial

EXPERIMENTAL

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

Behavioral: Suicide Prevention Intensive Outpatient Program

Interventions

participation in a suicide prevention intensive outpatient program

Open PilotOpen-label trial

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metrocare Services

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Suicide, AttemptedSuicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Beth D. Kennard, PsyD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Phase 1: Treatment Development Phase 2: Pilot Group Phase 3: Open Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 2, 2019

First Posted

June 20, 2019

Study Start

August 1, 2016

Primary Completion

August 31, 2020

Study Completion

December 31, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations