NCT07170657

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Nov 2025Nov 2026

First Submitted

Initial submission to the registry

August 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 5, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

August 11, 2025

Last Update Submit

January 28, 2026

Conditions

Keywords

Peer Support Specialist (PSS)Recovery Education and Support (RES) ProgramTeenageHigh School TeenUT Southwestern Medical CenterMental Health RecoveryOnlineVirtual

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (8)

  • Changes in symptoms associated with anxiety as measured by GAD 7 at 2 weeks

    Baseline, 2 weeks

  • Changes in symptoms associated with anxiety as measured by GAD 7 at 4 weeks

    Baseline, 4 weeks

  • Changes in symptoms associated with anxiety as measured by GAD 7 at 6 weeks

    Baseline, 6 weeks

  • Changes in symptoms associated with anxiety as measured by GAD 7 at 8 weeks

    Baseline, 8 weeks

  • Changes in symptoms associated with depression as measured by PHQ-9 at 2 weeks

    Baseline, 2 weeks

  • +3 more secondary outcomes

Study Arms (2)

Cohort A: Intervention Group with PSS, TP, and RES

EXPERIMENTAL

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.

Behavioral: Peer Support Services Recovery

Cohort B: Standard of Care

NO INTERVENTION

Scheduled telephone call visit with a member of the research team. Qualitative and quantitative assessments.

Interventions

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.

Cohort A: Intervention Group with PSS, TP, and RES

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (10)

  • 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.

    BACKGROUND
  • White S, Foster R, Marks J, Morshead R, Goldsmith L, Barlow S, Sin J, Gillard S. The effectiveness of one-to-one peer support in mental health services: a systematic review and meta-analysis. BMC Psychiatry. 2020 Nov 11;20(1):534. doi: 10.1186/s12888-020-02923-3.

    PMID: 33176729BACKGROUND
  • Lyons N, Cooper C, Lloyd-Evans B. A systematic review and meta-analysis of group peer support interventions for people experiencing mental health conditions. BMC Psychiatry. 2021 Jun 23;21(1):315. doi: 10.1186/s12888-021-03321-z.

    PMID: 34162340BACKGROUND
  • Walker G, Bryant W. Peer support in adult mental health services: a metasynthesis of qualitative findings. Psychiatr Rehabil J. 2013 Mar;36(1):28-34. doi: 10.1037/h0094744.

    PMID: 23477647BACKGROUND
  • Davidson L, Bellamy C, Guy K, Miller R. Peer support among persons with severe mental illnesses: a review of evidence and experience. World Psychiatry. 2012 Jun;11(2):123-8. doi: 10.1016/j.wpsyc.2012.05.009.

    PMID: 22654945BACKGROUND
  • Nugent C. SAMSHA's working definition of recovery. In: SAMSHA, editor. 2012. p. 8.

    BACKGROUND
  • Soe K, Babajide A, Gibbs T (2019). American Psychiatric Association Position Statement on Transitional Age Youth. American Psychiatric Association. Accessed from https://www.psychiatry.org/home/policy-finder?k=adolescent

    BACKGROUND
  • Centers for Disease Control and Prevention. (2022). Web-based Injury Statistics Query and Reporting System (WISQARS). Atlanta, GA: National Centers for Injury Prevention and Control, Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/injury/wisqars/index.html.

    BACKGROUND
  • Merikangas KR, He JP, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9. doi: 10.1016/j.jaac.2010.05.017. Epub 2010 Jul 31.

    PMID: 20855043BACKGROUND
  • Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.

    PMID: 15939837BACKGROUND

MeSH Terms

Conditions

Suicidal IdeationSuicide, AttemptedAnxiety Disorders

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Joseph Guillory, M.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cohort A: Intervention Group Cohort B: Standard of Care
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2025

First Posted

September 12, 2025

Study Start

November 5, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

At this time - there is no intention of sharing individual participant data as this is a pilot study, and due to the relatively small number of participants, any data that is shared or published will be in aggregate.

Locations