자살 충동을 느끼는 청소년을 위한 디지털 동료 지원 중재에 대한 파일럿 평가 (SWEEP)
Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, New York. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment (EMA) app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This is a single-arm investigation of a novel suicide prevention intervention, called "Supporting Wellbeing with Everyday Experiences of Peers" (SWEEP). In a preliminary phase (Phase 1) of the study, suicide recovery narratives: short first-person stories about lived experience with and recovery from Bronx Adolescents will be collected. The investigator team will then evaluate evaluate the anti-suicidal benefits of this intervention in a single-arm trial. In a subsequent phase (Phase 2), adolescent participants (n=46) will be provided with the SWEEP intervention, which involves reading or listening to one suicide recovery narrative each day during the 14-day trial. Six of the 46 participants will be adolescents, with recent suicidal thoughts or depression, who are currently receiving mental healthcare in Montefiore's Outpatient Psychiatry Department, rather than those on the waitlist to receive these services. All six participants will then complete a post-intervention qualitative interview to inform potential changes to intervention procedures. During this second phase, suicide recovery narratives will be provided, in audio and text formats, via a smartphone app. That same smartphone app will also collect real-time (ecological momentary) assessments of suicidal thoughts, as well as secondary and additional outcomes, five times per day. The investigator team will evaluate whether participants experience reductions in the intensity of suicidal thoughts over the course of the 14-day trial. During Phase 3, participants will be recruited to a control condition (n=15) and a treatment condition (n=30). Those in the Phase 3 treatment condition will receive the same intervention (1 SWEEP narrative per day for 14 days + 3x/day EMA) as those in Phase 2. Those in the Control condition will receive 3x/day EMA only.
A recent amendment approved by the IRB decreased the maximum response time for follow-up after participants report an adverse event from 24 hours to 12 hours.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Peter J Franz, Ph.D.
- 전화번호: 6077278620
- 이메일: peter.franz@einsteinmed.edu
연구 장소
-
-
New York
-
The Bronx, New York, 미국, 10467
- 모병
- Montefiore Health System
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- past-month history of suicidal thoughts
- past-month history of Major depressive disorder
- possession of apple or android smartphone with data plan
Exclusion Criteria:
- inability to read/write in English
- Active mania
- Active psychosis
- Autism spectrum disorder
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Intervention
This is a single-arm study. All participants will be allocated to the intervention arm, in which they will receive the digital narrative therapy. |
Each day during a 14-day trial period, participants will receive one narrative featuring lived experience with and recovery from suicidal thoughts and behaviors. These narratives will be presented in audio and text format via a smartphone app. Participants will also complete self-report surveys assessing study outcomes using the same smartphone app five times per day.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Suicidal Thoughts
기간: 5 times per day during 14-day trial
|
Participants will self-report their current subjective intensity of suicidal thoughts using an 11-point Likert-type scale, with higher scores indicating more intense suicidal thoughts. |
5 times per day during 14-day trial
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Suicidal Urge Resistance
기간: 5 times per day during 14-day trial
|
Participants will self-report the strength of their current ability to resist suicidal urges using an 11-point Likert-type scale, with higher scores indicating greater ability to resist suicidal urges. |
5 times per day during 14-day trial
|
|
Social Connectedness
기간: 5 times per day during 14-day trial
|
Participants will self-report their current feelings of being connected to other people using an 11-point Likert-type scale, with higher scores indicating feeling more being connected to other people. |
5 times per day during 14-day trial
|
|
Optimism
기간: 5 times per day during 14-day trial
|
Participants will self-report their current of feelings of optimism about the future using an 11-point Likert-type scale, with higher scores indicating greater optimism. |
5 times per day during 14-day trial
|
|
Social Support
기간: 5 times per day during 14-day trial
|
Participants will self-report their current perception of the availability of emotional support from others using an 11-point Likert-type scale, with higher scores indicating the perception greater availability of emotional support from others. |
5 times per day during 14-day trial
|
|
Intervention Acceptability
기간: Study conclusion (at the end of the 14-day trial)
|
Participants will self-report their current perception of acceptability of the SWEEP intervention across three items. Participants will rate the usefulness of receiving the narratives using a 7-point Likert-type scale, with higher scores indicating that the narratives were more useful. Participants will rate the difficulty of reading or listening to the narratives each day using a 7-point Likert-type scale, with higher scores indicating that the narratives were more difficult to read or listen to. This item will be reverse coded. Participants will rate how willing they are to recommend the narratives to their peers using a 7-point Likert-type scale, with higher scores indicating greater willingness to recommend the narratives. Each of these items will be evaluated in isolation, as well as in aggregate using both summation and an arithmetic mean score. |
Study conclusion (at the end of the 14-day trial)
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Emotions
기간: 5 times per day during 14-day trial
|
Participants will self-report the current intensity of 10 emotions: excited, guilty, scared, proud, irritated, ashamed, inspired, nervous, determined, angry. Each emotion will be rated on an 11-point Likert-type scale with higher scores indicating more intense emotion. Each of these items will be evaluated in isolation, as well as in aggregate using arithmetic mean. For aggregating an overall emotion score, the positive emotions excited, proud, inspired, and determined will be reverse-scored to provide an aggregate rating of negative emotion. |
5 times per day during 14-day trial
|
|
Treatment Readiness
기간: Baseline (prior to starting the 14-day trail) and study conclusion (at the end of the 14-day trial)
|
Participants will self-report their current readiness for mental health treatment across 4 items. Participants will rate their motivation for beginning regular mental health services using a 7-point Likert-type scale, with higher scores indicating greater readiness to begin regular services. Participants will rate their anxiety about discussing personal difficulties with a mental health professional using a 7-point Likert-type scale, with higher scores indicating greater anxiety. This item will be reverse coded. Participants will rate how confident they feel that regular mental health services will be helpful using a 7-point Likert-type scale, with higher scores indicating greater confidence. Participants will rate how necessary they feel that regular mental health services are for them using a 7-point Likert-type scale, with higher scores indicating greater feelings of necessity. Each item will be evaluated in isolation and in aggregate using both summation and arithmetic mean score. |
Baseline (prior to starting the 14-day trail) and study conclusion (at the end of the 14-day trial)
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Peter J Franz, Ph.D., Albert Einstein College of Medicine
간행물 및 유용한 링크
일반 간행물
- Franklin JC, Ribeiro JD, Fox KR, Bentley KH, Kleiman EM, Huang X, Musacchio KM, Jaroszewski AC, Chang BP, Nock MK. Risk factors for suicidal thoughts and behaviors: A meta-analysis of 50 years of research. Psychol Bull. 2017 Feb;143(2):187-232. doi: 10.1037/bul0000084. Epub 2016 Nov 14.
- Van Orden KA, Witte TK, Cukrowicz KC, Braithwaite SR, Selby EA, Joiner TE Jr. The interpersonal theory of suicide. Psychol Rev. 2010 Apr;117(2):575-600. doi: 10.1037/a0018697.
- Evans K, Tyrer P, Catalan J, Schmidt U, Davidson K, Dent J, Tata P, Thornton S, Barber J, Thompson S. Manual-assisted cognitive-behaviour therapy (MACT): a randomized controlled trial of a brief intervention with bibliotherapy in the treatment of recurrent deliberate self-harm. Psychol Med. 1999 Jan;29(1):19-25. doi: 10.1017/s003329179800765x.
- Bietti LM, Tilston O, Bangerter A. Storytelling as Adaptive Collective Sensemaking. Top Cogn Sci. 2019 Oct;11(4):710-732. doi: 10.1111/tops.12358. Epub 2018 Jun 28.
- Franz PJ, Nook EC, Mair P, Nock MK. Using Topic Modeling to Detect and Describe Self-Injurious and Related Content on a Large-Scale Digital Platform. Suicide Life Threat Behav. 2020 Feb;50(1):5-18. doi: 10.1111/sltb.12569. Epub 2019 Jul 2.
- Gualano MR, Bert F, Martorana M, Voglino G, Andriolo V, Thomas R, Gramaglia C, Zeppegno P, Siliquini R. The long-term effects of bibliotherapy in depression treatment: Systematic review of randomized clinical trials. Clin Psychol Rev. 2017 Dec;58:49-58. doi: 10.1016/j.cpr.2017.09.006. Epub 2017 Sep 29.
- Rennick-Egglestone S, Morgan K, Llewellyn-Beardsley J, Ramsay A, McGranahan R, Gillard S, Hui A, Ng F, Schneider J, Booth S, Pinfold V, Davidson L, Franklin D, Bradstreet S, Arbour S, Slade M. Mental Health Recovery Narratives and Their Impact on Recipients: Systematic Review and Narrative Synthesis. Can J Psychiatry. 2019 Oct;64(10):669-679. doi: 10.1177/0706743719846108. Epub 2019 May 2.
- Stip E, Ostlundh L, Abdel Aziz K. Bibliotherapy: Reading OVID During COVID. Front Psychiatry. 2020 Dec 7;11:567539. doi: 10.3389/fpsyt.2020.567539. eCollection 2020.
- Weimerskirch PJ. Benjamin Rush and John Minson Galt, II. Pioneers of bibliotherapy in America. Bull Med Libr Assoc. 1965 Oct;53(4):510-26.
- Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.
- Franz PJ, Mou D, Kessler DT, Stubbing J, Jaroszewski AC, Ray S, Cao-Silveira VB, Bachman S, Schuster S, Graupensperger D, Alpert JE, Porath M, Nock MK. Digital bibliotherapy as a scalable intervention for suicidal thoughts: A randomized controlled trial. J Consult Clin Psychol. 2022 Aug;90(8):626-637. doi: 10.1037/ccp0000752.
- Centers for Disease Control and Prevention. 10 leading causes of death, United States. WISQARS Fatal Injury Data Visualization Tool.
- Fox KR, Huang X, Guzman EM, Funsch KM, Cha CB, Ribeiro JD, Franklin JC. Interventions for suicide and self-injury: A meta-analysis of randomized controlled trials across nearly 50 years of research. Psychol Bull. 2020 Dec;146(12):1117-1145. doi: 10.1037/bul0000305. Epub 2020 Oct 29.
- Alvarez K, Polanco-Roman L, Samuel Breslow A, Molock S. Structural Racism and Suicide Prevention for Ethnoracially Minoritized Youth: A Conceptual Framework and Illustration Across Systems. Am J Psychiatry. 2022 Jun;179(6):422-433. doi: 10.1176/appi.ajp.21101001.
- Bray MJC, Daneshvari NO, Radhakrishnan I, Cubbage J, Eagle M, Southall P, Nestadt PS. Racial Differences in Statewide Suicide Mortality Trends in Maryland During the Coronavirus Disease 2019 (COVID-19) Pandemic. JAMA Psychiatry. 2021 Apr 1;78(4):444-447. doi: 10.1001/jamapsychiatry.2020.3938.
- Joiner T. Why People Die by Suicide. Harvard University Press; 2005.
- Millner AJ, Lee MD, Nock MK. Describing and Measuring the Pathway to Suicide Attempts: A Preliminary Study. Suicide Life Threat Behav. 2017 Jun;47(3):353-369. doi: 10.1111/sltb.12284. Epub 2016 Aug 1.
- Roswarski T, Dunn J. The Role of Help and Hope in Prevention and Early Intervention with Suicidal Adolescents: Implications for Mental Health Counselors. J Ment Health Couns. 2009;31(1):34-46. doi:10.17744/mehc.31.1.u150745762627518
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2023-15217
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The research team will consider requests to share specific data with qualified research teams upon request
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .