Teen Recovery Through Inspiration, Support, and Empowerment

Официальное название

Teen Recovery Through Inspiration, Support, and Empowerment (RISE)

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Change in Suicidal Ideation as measured by C-SSRS at 2 weeks from baseline [Срок оценки: Baseline, 2 weeks]
• Change in Suicidal Ideation as measured by C-SSRS at 4 weeks from baseline [Срок оценки: Baseline, 4 weeks]
• Change in Suicidal Ideation as measured by C-SSRS at 6 weeks from baseline [Срок оценки: Baseline, 6 weeks]
• Change in Suicidal Ideation as measured by C-SSRS at 8 weeks from baseline [Срок оценки: Baseline, 8 weeks]

Вторичные конечные точки (8)

• Changes in symptoms associated with anxiety as measured by GAD 7 at 2 weeks [Срок оценки: Baseline, 2 weeks]
• Changes in symptoms associated with anxiety as measured by GAD 7 at 4 weeks [Срок оценки: Baseline, 4 weeks]
• Changes in symptoms associated with anxiety as measured by GAD 7 at 6 weeks [Срок оценки: Baseline, 6 weeks]
• Changes in symptoms associated with anxiety as measured by GAD 7 at 8 weeks [Срок оценки: Baseline, 8 weeks]
• Changes in symptoms associated with depression as measured by PHQ-9 at 2 weeks [Срок оценки: Baseline, 2 weeks]
• Changes in symptoms associated with depression as measured by PHQ-9 at 4 weeks [Срок оценки: Baseline, 4 weeks]
• Changes in symptoms associated with depression as measured by PHQ-9 at 6 weeks [Срок оценки: Baseline, 6 weeks]
• Changes in symptoms associated with depression as measured by PHQ-9 at 8 weeks [Срок оценки: Baseline, 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Southwestern Medical Center — Dallas

Публикации

• 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, 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 33176729
• 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 34162340
• 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 23477647
• 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 22654945
• Nugent C. SAMSHA's working definition of recovery. In: SAMSHA, editor. 2012. p. 8.
• 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
• 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.

Идентификаторы

NCT: NCT07170657 · STU-2024-0493

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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