- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02674932
Character Strengths Intervention Among Psychiatrically Hospitalized Youth
Assessment of a Character Strengths Intervention in Improving Treatment Outcomes Among Psychiatrically Hospitalized Youth
연구 개요
상태
상세 설명
The primary aim of this study is to investigate whether a character strengths-based intervention results in significant improvements in measures of depression, anxiety, resiliency, optimism, self-perception, and life-satisfaction of psychiatrically hospitalized youth up to three months following admission. Secondary aims are to: (1) examine participants' strengths profile to identify potential correlates between character strengths, psychiatric diagnoses and intervention effectiveness; and (2) determine whether patients who continue to incorporate their strengths into coping skills at follow-up assessments exhibit greater improvement over-time.
Participants will be 210 adolescents aged 12 to 17 years admitted to the Child and Adolescent Psychiatric Inpatient Program and will be randomized into one of the three groups. All participants will complete the Values in Action Inventory of Strengths for Youth (VIA-Youth) Survey on their second hospital day and subsequently receive the signature strengths intervention (experimental group), coping skills with memory aids comparison exercise (positive control group), or coping skills without memory aids (treatment-as-usual control group). Outcome measures will be completed by all participants at baseline (day 1 on unit), post-treatment (day 4 on unit), and 1- and 3-months following admission. The proposed research represents a change in paradigm, as we aim to specifically examine the therapeutic benefit of the positive psychology element of our intervention conducted in the pilot study among youth with severe mental illness.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient on Child and Adolescent Psychiatric Unit
Exclusion Criteria:
- Cognitive disability or severe psychosis preventing understanding of survey measures
- Prior use of VIA-Youth Survey
- Absence of legal guardian to consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Signature Strengths
Patients will complete the Values in Action Youth Survey (VIA-Youth) and will receive a list of his/her top character strengths ("signature strengths").
The patient will then participate in the Identifying and Using Signature Strengths Intervention.
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The purpose of the intervention is to identify and focus on one's morally valued strengths and utilize them (i.e.
incorporate them into coping skills) to overcome challenges.
The study team member and patient will discuss each top strength and ways to use them as coping skills.
The patient will identify 2-4 coping mechanisms per strength, and will write his/her strengths and self-identified coping skills on index cards.
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활성 비교기: Coping Skills + Memory Aid
Patients will complete the VIA-Youth but will not receive any results.
The patient will then participate in the Identifying and Writing Down Coping Skills Intervention.
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The study team member and patient will discuss the importance of having coping skills to deal with stressful and difficult situations.
The patient will then identify at least six coping skills and write them down on index cards.
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다른: Coping Skills (Treatment as Usual)
Patients will complete the VIA-Youth but will not receive any results.
After completing the VIA-Youth, the study team member and patient will have a treatment-as-usual discussion about coping skills.
(This is equivalent to treatment as usual that is already provided on the psychiatric unit-doctors and nurses on the unit already have this a discussion about coping skills with patients).
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The study team member and patient will discuss the importance of having coping skills to deal with stressful and difficult situations.
The patient will then identify coping skills that could be helpful (but will not write them down).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in depression symptoms over time compared to baseline
기간: baseline, 3 days, 1 month, 3 months
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Depression will be measured using Patient Health Questionnaire (PHQ) for adolescents, and percent change in depression score will be compared across the 3 arms.
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baseline, 3 days, 1 month, 3 months
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Change in anxiety symptoms over time compared to baseline
기간: baseline, 3 days, 1 month, 3 months
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Anxiety will be measured using the 5-item Screen for Child Anxiety Related Emotional Disorders (SCARED), and percent change in anxiety score will be compared across the 3 arms.
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baseline, 3 days, 1 month, 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in self-esteem over time compared to baseline
기간: baseline, 3 days, 1 month, 3 months
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Self-esteem will be measured using the Rosenberg Self-Esteem Scale (SES), and percent change in self-esteem score will be compared across the 3 arms.
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baseline, 3 days, 1 month, 3 months
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Change in self-efficacy over time compared to baseline
기간: baseline, 3 days, 1 month, 3 months
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Self-efficacy will be measured using the General Self-Efficacy Scale (GSE), and percent change in self-efficacy score will be compared across the 3 arms.
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baseline, 3 days, 1 month, 3 months
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Change in resiliency over time compared to baseline
기간: baseline, 3 days, 1 month, 3 months
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Resiliency will be measured using the 10-item Connor Davidson Resiliency Scale (CD-RISC-10), and percent change in resiliency score will be compared across the 3 arms.
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baseline, 3 days, 1 month, 3 months
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Change in life-satisfaction over time compared to baseline
기간: baseline, 3 days, 1 month, 3 months
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Life satisfaction will be measured using the Brief Multidimensional Students' Life Satisfaction Scale - PTPB version (BMSLSS-PTPB), and percent change in life satisfaction score will be compared across the 3 arms.
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baseline, 3 days, 1 month, 3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Paresh D Patel, MD, PhD, Department of Psychiatry, University of Michigan
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HUM00107976
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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