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Clinical Trial NCT07170657 (Teen RISE) for Suicidal Ideation, Suicide Attempt, Anxiety, Depression Disorders is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of Texas Southwestern Medical CenterTeen Recovery Through Inspiration, Support, and Empowerment (Teen RISE) 40 Novel Treatment
Clinical Trial NCT07170657 (Teen RISE) is an interventional study for Suicidal Ideation, Suicide Attempt, Anxiety, Depression Disorders that is recruiting. It started on 5 November 2025 with plans to enroll 40 participants. Led by University of Texas Southwestern Medical Center, it is expected to complete by 1 November 2026. The latest data from ClinicalTrials.gov was last updated on 30 January 2026.
Brief Summary
The goal of this pilot study is to test the effectiveness of a novel intervention for teenagers (ages 15-18) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and to improve mental health recovery by using an online recovery education and support program.
The current standard of care (SOC...
Show MoreDetailed Description
Purpose:
- This is a pilot study to test the effectiveness of a novel intervention aimed at reducing the incidences of suicidality, depression, anxiety, re-hospitalization rates, and improving mental health recovery by utilizing outpatient services, and medication adherence for high school teenagers ages 15-18, with mental health conditions verses the standard of care (SOC) at discharge which only provides a dischar...
Official Title
Teen Recovery Through Inspiration, Support, and Empowerment (RISE)
Conditions
Suicidal IdeationSuicide AttemptAnxietyDepression DisordersPublications
Scientific articles and research papers published about this clinical trial:- Peer Support Services. Texas Health and Human Services. (2019). Retrieved February 21, 2023, from https://www.hhs.texas.gov/providers/behavioral-health-services-providers/peer-support-services.
- White S, Foster R, Marks J, Morshead R, Goldsmith L, Barlow S,...
Other Study IDs
- Teen RISE
- STU-2024-0493
NCT ID Number
Start Date (Actual)
2025-11-05
Last Update Posted
2026-01-30
Completion Date (Estimated)
2026-11
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Peer Support Specialist (PSS)
Recovery Education and Support (RES) Program
Teenage
High School Teen
UT Southwestern Medical Center
Mental Health Recovery
Online
Virtual
Recovery Education and Support (RES) Program
Teenage
High School Teen
UT Southwestern Medical Center
Mental Health Recovery
Online
Virtual
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCohort A: Intervention Group with PSS, TP, and RES Virtual one on one meetings peer support specialist (PSS), trained peer (TP) using recovery education and support program (RES). Group meetings with PSS, TP, and other participants. Qualitative and quantitative assessments. | Peer Support Services Recovery A program of mental health recovery through one-on-one and small group meetings with a PSS and TP using RES for individuals recently discharged from an acute care psychiatric facility. |
No InterventionCohort B: Standard of Care Scheduled telephone call visit with a member of the research team. Qualitative and quantitative assessments. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Suicidal Ideation as measured by C-SSRS at 2 weeks from baseline | Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 2 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior). | Baseline, 2 weeks |
Change in Suicidal Ideation as measured by C-SSRS at 4 weeks from baseline | Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 4 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior). | Baseline, 4 weeks |
Change in Suicidal Ideation as measured by C-SSRS at 6 weeks from baseline | Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 6 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior). | Baseline, 6 weeks |
Change in Suicidal Ideation as measured by C-SSRS at 8 weeks from baseline | Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 8 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior). | Baseline, 8 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Changes in symptoms associated with anxiety as measured by GAD 7 at 2 weeks | A reduction of anxiety symptoms and rates of occurrence will be measured using the Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms with 4 response options: 0- "Not at all", 1-"Several days", 2-"More than half the days", 3-"Nearly every day". Total score can range from 0 to 21 with higher scores indicating higher levels of anxiety. | Baseline, 2 weeks |
Changes in symptoms associated with anxiety as measured by GAD 7 at 4 weeks | A reduction of anxiety symptoms and rates of occurrence will be measured using the Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms with 4 response options: 0- "Not at all", 1-"Several days", 2-"More than half the days", 3-"Nearly every day". Total score can range from 0 to 21 with higher scores indicating higher levels of anxiety. | Baseline, 4 weeks |
Changes in symptoms associated with anxiety as measured by GAD 7 at 6 weeks | A reduction of anxiety symptoms and rates of occurrence will be measured using the Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms with 4 response options: 0- "Not at all", 1-"Several days", 2-"More than half the days", 3-"Nearly every day". Total score can range from 0 to 21 with higher scores indicating higher levels of anxiety. | Baseline, 6 weeks |
Changes in symptoms associated with anxiety as measured by GAD 7 at 8 weeks | A reduction of anxiety symptoms and rates of occurrence will be measured using the Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms with 4 response options: 0- "Not at all", 1-"Several days", 2-"More than half the days", 3-"Nearly every day". Total score can range from 0 to 21 with higher scores indicating higher levels of anxiety. | Baseline, 8 weeks |
Changes in symptoms associated with depression as measured by PHQ-9 at 2 weeks | A reduction of depression symptoms and rates of occurrence will be measured using the Patient Health Questionnaire (PHQ) - a self reported inventory used as a screening and diagnostic tool for depression.
The PHQ-9 is a 9-item self-reported instrument that measures depression symptoms. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 27, with higher scores indicating higher levels of depression. | Baseline, 2 weeks |
Changes in symptoms associated with depression as measured by PHQ-9 at 4 weeks | A reduction of depression symptoms and rates of occurrence will be measured using the Patient Health Questionnaire (PHQ) - a self reported inventory used as a screening and diagnostic tool for depression.
The PHQ-9 is a 9-item self-reported instrument that measures depression symptoms. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 27, with higher scores indicating higher levels of depression. | Baseline, 4 weeks |
Changes in symptoms associated with depression as measured by PHQ-9 at 6 weeks | A reduction of depression symptoms and rates of occurrence will be measured using the Patient Health Questionnaire (PHQ) - a self reported inventory used as a screening and diagnostic tool for depression.
The PHQ-9 is a 9-item self-reported instrument that measures depression symptoms. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 27, with higher scores indicating higher levels of depression. | Baseline, 6 weeks |
Changes in symptoms associated with depression as measured by PHQ-9 at 8 weeks | A reduction of depression symptoms and rates of occurrence will be measured using the Patient Health Questionnaire (PHQ) - a self reported inventory used as a screening and diagnostic tool for depression.
The PHQ-9 is a 9-item self-reported instrument that measures depression symptoms. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 27, with higher scores indicating higher levels of depression. | Baseline, 8 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
15 Years
Eligible Sexes
All
- Chief complaint of suicidal ideation, suicide attempt, depression, and/or anxiety
- recently discharged from inpatient care or from emergency department
- men and women ages 15-18 years old
- primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III)
University of Texas Southwestern Medical CenterStudy Responsible Party
Joseph Guillory, Principal Investigator, Principal Investigator, University of Texas Southwestern Medical Center
Study Central Contact
Contact: Cameron M Pham, 214-648-4885, [email protected]
1 Study Locations in 1 Countries
Texas
The University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States
Recruiting