- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00951821
Concurrent Treatment for Depressed Parents and DepressedAdolescents
Concurrent Treatment for Parents and Adolescents Who Attempt Suicide
연구 개요
상세 설명
Depression, like many psychiatric disorders, has a genetic component that makes it more likely that members of the same family will have the disorder. Depression in parents, particularly mothers, may put the children at greater risk for depression. When an adolescent whose parent is depressed develops depression himself or herself, treating both the parent and the adolescent may be more effective than treating only the adolescent. This study will test a depression treatment that targets depressed suicidal adolescents with a parent or primary caretaker who is also depressed and has a history of suicidality.
Participation in this study will last 6 months. Participants will be randomly assigned to receive either concurrent parent and adolescent treatment or adolescent only treatment. For those assigned to concurrent treatment, both the adolescent participants and one of their parents will receive individual cognitive behavioral therapy (CBT) counseling sessions and joint family counseling sessions. In the adolescent only treatment condition, adolescent participants will receive individual CBT sessions, but parents will not, and both will receive joint family sessions. Counseling sessions will last 1 hour and occur weekly for 3 months, and then every other week for 3 months. CBT identifies and attempts to change problematic thought patterns. All participants will receive medication consultation if necessary.
Participants will complete assessments at baseline, post-treatment, and 6 months after completing treatment. These assessments will include questionnaires and interviews about depression, suicidal thoughts, mood regulation, behavioral problems, and family. At post-treatment and the 6-month follow-up, participants will also be asked to give feedback about the counseling, medication consultation, and their satisfaction.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02912
- Brown University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for Adolescents:
- Lives at home with at least one parent or guardian
- Speaks English
- Must have made a suicide attempt and be diagnosed with major depressive disorder (MDD)
Inclusion Criteria for Primary Caretakers:
- Speaks English
- Current diagnosis of MDD and a history of suicidality
Exclusion Criteria for Adolescents:
- Judged to have developmental or cognitive delays or psychotic disorders on the basis of a standard psychiatric exam
- Diagnosis of bipolar disorder or a substance dependence (people with a diagnosis of substance abuse are eligible)
- Only one adolescent per family is eligible
Exclusion Criteria for Primary Caretakers:
- Diagnosis of bipolar disorder or substance dependence
- If taking antidepressants, not on a stable dose for 3 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Concurrent treatment
Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
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Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase.
The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment.
다른 이름들:
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활성 비교기: Adolescent treatment only
Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.
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Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Beck Depression Inventory - Adolescent Report, Change in Symptom Level
기간: 12 months
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self-report measure of depressed mood - range of scores 0 to 60; higher scores indicate worse depression.
The data in this outcome refer to change from baseline to 12 month follow-up, per the adolescent self-report.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Beck Suicide Scale - Adolescent Response
기간: Measured at 12 months
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measure of suicidal ideation - scale ranges from 0 to 38 - higher scores indicate higher suicidal ideation.
These data refer to adolescent respondents.
The outcome is a change score so range is from -38 to 38.
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Measured at 12 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
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. .
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