Teen Recovery Through Inspiration, Support, and Empowerment

Not Applicable

Recruiting

• Conditions: Suicidal Ideation; Depression Disorders; Suicide Attempt; Anxiety

• Registration Number: NCT07170657
• Lead Sponsor: University of Texas Southwestern Medical Center

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) for these patients at discharge includes a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources.

The intervention being tested involves the implementation of an online recovery education and support (RES) program, involving one-on-one and small group meetings led by trained teen peers (TPs) and peer support specialists (PSS).

Participants will be assigned to either Cohort A or B for 8 weeks.

Cohort A will be the intervention group with online access to an RES, TP, and PSS.

* Week 1-4: One-on-one meetings with PSS and TP for education and support. Assessments will be completed at week 2 and 4.

* Week 5 and 7: one-one meetings with PSS and TP for education and support.

* Week 6 and 8: small group meetings with PSS, TP, and other participants. Assessments will be completed during Weeks 6 and 8.

Cohort B will be the SOC group with no PSS, TP, or RES.

* Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at Weeks 2 and 4.

* Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and8.

Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.

Detailed 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 discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources.

* The intervention will use trained peers (TP), peer support specialists (PSS), and an online recovery education and support (RES) platform aimed at improving knowledge, awareness, and utilization of recovery and wellness programs for those patients recently discharged from an acute psychiatric treatment facility.

Objectives:

* Implement a program of mental health recovery education and support through virtual one-on-one and small group meetings with a TP and PSS for individuals recently discharged from an acute care psychiatric facility to determine the effectiveness of: Reduction of suicidality, depression, anxiety, re-hospitalization rate AND Improvement in mental health recovery by participating in outpatient services, and medication adherence.

* Determine if peer-led interventions improve knowledge, awareness, and utilization of recovery and wellness programs and support.

Endpoints:

* Determine the efficacy of peer-led, virtual one-on-one and group sessions vs standard of care (SOC) based on responses to assessments, adherence to medication, and re-admittance to a psychiatric facility.

* Determine if there is a difference in outcome based on demographics (race, ethnic background, diagnosis, public vs private insurance, and zip code)

Study Design:

\- This is a 1:1 randomized, 8-week interventional study that will include an orientation session and a collection of baseline data. At the conclusion of the orientation session, subjects will be randomly assigned to Cohort A or B. Target recruitment is 40 for this study; 20 subjects in Cohort A and 20 in Cohort B. At the conclusion of the study, both groups will be provided a list resources for therapy, outpatient psychiatry providers/services, online recovery education and support (RES), local emergency departments and inpatient psychiatric facilities.

Cohort A - Intervention group with RES, PSS, and TP

* Weeks 1-4: one-on-one meetings with peer support specialist (PSS) for education and support. Qualitative and quantitative assessments completed at weeks 2 and 4

* Weeks 5-8: Biweekly (every other week) of one-on-one meetings with PSS and TP for education and support. Biweekly group meetings with PSS, TP, and other participants. Qualitative and quantitative assessments completed at weeks 6 and 8

Cohort B - SOC group with no PSS, TP, or RES; participants are responsible for finding resources or group support by following the information provided at discharge

* Weeks 1-4: Weekly check-in phone calls with a member of the research team. Qualitative and quantitative assessments completed at weeks 2 and 4 (completed during phone call check in)

* Weeks 5-8: Biweekly (every other week) check-in phone calls with a member of the research team. Qualitative and quantitative assessments completed at weeks 6 and 8 (completed during phone call check in).

Study Timeline

• Study Start: 2025-05-27
• Study First Submitted: 2025-08-11
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

- primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Suicidal Ideation as measured by C-SSRS at 2 weeks from baseline	Baseline, 2 weeks	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).
Change in Suicidal Ideation as measured by C-SSRS at 4 weeks from baseline	Baseline, 4 weeks	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).
Change in Suicidal Ideation as measured by C-SSRS at 6 weeks from baseline	Baseline, 6 weeks	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).
Change in Suicidal Ideation as measured by C-SSRS at 8 weeks from baseline	Baseline, 8 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Changes in symptoms associated with anxiety as measured by GAD 7 at 2 weeks	Baseline, 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.
Changes in symptoms associated with anxiety as measured by GAD 7 at 4 weeks	Baseline, 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.
Changes in symptoms associated with anxiety as measured by GAD 7 at 6 weeks	Baseline, 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.
Changes in symptoms associated with anxiety as measured by GAD 7 at 8 weeks	Baseline, 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.
Changes in symptoms associated with depression as measured by PHQ-9 at 2 weeks	Baseline, 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.
Changes in symptoms associated with depression as measured by PHQ-9 at 4 weeks	Baseline, 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.
Changes in symptoms associated with depression as measured by PHQ-9 at 6 weeks	Baseline, 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.
Changes in symptoms associated with depression as measured by PHQ-9 at 8 weeks	Baseline, 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.

Trial Locations

Locations (1)

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States