- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01534377
Interpersonal Psychotherapy for Adolescent Girls (IPT)
Prevention of Depression in Maltreated and Nonmaltreated Adolescents
연구 개요
상세 설명
Child maltreatment poses a serious public health problem and heightens the risk of psychopathology across the life course. Adolescence also represents a peak time for the emergence of depressive disorders particularly in girls. Effective interventions to prevent and treat depression in low income adolescent girls with or without histories of maltreatment are needed.
Three groups will be recruited: Maltreated Depressive Symptoms (MDS), Nonmaltreated Depressive Symptoms (NDS), and a Nonmaltreated Nonsymptomatic Comparison (NNC), comparable in SES, race/ethnicity, and household composition. The MDS and NDS groups will be randomized into IPT-A or Enhanced Care (EC). Adolescent girls in these groups will receive 13 sessions of therapy. Girls in the NNC group will only complete research visits.
Research assessments will be conducted at T1 (baseline/prior to intervention), T2 (6-weeks mid-intervention), T3 (end of intervention), T4 (1-year post) and T5 (18 months post). Girls and their mothers will participate in these research sessions. A multi-level-of-analysis approach, integrating genotyping, hormone assays, cognitive testing, adolescent- and maternal-report, mother-teen observation, and DHS and school records will be utilized to assess the effectiveness of the interventions.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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Rochester, New York, 미국, 14608
- Mt. Hope Family Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- girls
- ages 13-15 years old
- low SES status
- live in Rochester or surrounding counties
- girls in the maltreated depressive symptom group will have CPS-documented child maltreatment
- girls in the nonmaltreated depressive symptom group will not have CPS- documented child maltreatment
- girls in the nonmaltreated nonsymptomatic comparison group will have no current or past mental illness and no documented child maltreatment
Exclusion Criteria:
- taking antidepressants or prescription medications for anxiety
- already receiving mental health treatment
- actively suicidal
- diagnosed with a severe mental disorder
- abusing drugs or alcohol
- evidence of compromised cognitive ability
- evidence of a pervasive developmental disorder
- evidence of a major physical or neurological disorder
- non-English speaking
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Interpersonal Psychotherapy
Adolescents will receive Interpersonal Psychotherapy for the treatment and prevention of depression.
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Adolescents will receive IPT-A a manualized intervention for depression and prevention of depression that emphasizes current interpersonal relationships, focusing on their immediate social context.
다른 이름들:
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실험적: Enhanced Care
Adolescents will receive the Enhanced care model or care that they would typically receive in community setting to treat and prevent depression.
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Adolescents will receive enhanced care which is consistent with care typically provided in community settings to treat and prevent depression.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in adolescent depressive symptoms from baseline to post-intervention
기간: Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention
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To evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A) for decreasing depressive symptoms and preventing depression in low-income ethnically and culturally diverse adolescent girls with and without histories of child maltreatment
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Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sheree Toth, PhD, University of Rochester
- 수석 연구원: Dante Cicchetti, Ph.D., University of Minnesota
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 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. .