- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00536094
School-based Treatment for Anxious Children
School-Based CBT for Anxious African-American Children
연구 개요
상세 설명
Anxiety disorders are among the most common childhood disorders. Although anxiety is a normal part of life and growing up, for some children this anxiety becomes chronic, relentless, and progressively worse if left untreated. Physical symptoms typically accompany the intense anxiety caused by the disorder and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Anxiety disorders among children have become increasingly prevalent, indicating that excessive fear, worry, and anxiety in children are emerging public health issues. Recent studies have shown that CBT is an effective form of treatment for childhood anxiety disorders; however, it often requires the use of expert CBT clinicians. The purpose of this study is to deliver a school-based version of CBT to predominantly low-income, inner-city, African-American children with anxiety disorders. Clinicians within the school will undergo CBT training and adapt the treatment program to fit the needs of the participating children.
All participants in this study will undergo an initial evaluation to assess anxiety symptoms, disorders, and associated impairments. The children will then be randomly assigned to receive 12 weekly sessions of school-based CBT or treatment as usual, which will involve 12 weekly sessions of psychosocial treatment. Three parent sessions will be offered for families in both groups at Weeks 2, 6, and 10. All treatment sessions will occur at school during the day and will be led by school-based clinicians. A follow-up session will be conducted at post-treatment and 1 month after the last session to assess anxiety symptoms and disorders. Parent, teacher, and clinician ratings will also be used to assess the treatment outcomes of each child.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Meets DSM-IV criteria for primary diagnosis of generalized anxiety disorder (GAD), social anxiety disorder (SAD), specific phobia (SP), or social phobia (SOP)
- Received a score of at least 4 on the ADIS for DSM-IV:C's Clinician's Severity Rating Scale (CSR) for GAD, SAD, SP, and/or SOP
- Received a minimum 1 point difference in ADIS for DSM-IV:C severity scores between the primary disorder and other disorders (e.g., depressive disorders, disruptive behavior disorders, attention deficit hyperactive disorder [ADHD], and other anxiety disorders such as obsessive compulsive disorder [OCD], post-traumatic stress disorder [PTSD], acute stress disorder)
Exclusion Criteria:
- Diagnosed with a pervasive developmental disorder, mental retardation, organic mental disorders, schizophrenia, or other psychotic disorders
- Psychotic or suicidal
- Currently receiving treatment for anxiety
- Requires immediate or alternative treatment
- Previously failed a trial of at least 10 sessions for anxiety within 2 years of study entry
- Absent 50% of school days in the 2 months preceding random assignment to treatment groups
- History of child abuse and requires ongoing Department of Social Services supervision
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1
Participants will receive cognitive behavioral therapy for anxiety that includes exposure
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CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
다른 이름들:
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활성 비교기: 2
Participants will receive treatment as usual as delivered by school-based clinicians
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TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Anxiety Disorders Interview Schedule for DSM-IV: Child Version
기간: Measured at pre-treatment, post-treatment, and one month follow-up
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Measured at pre-treatment, post-treatment, and one month follow-up
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Screen for Child Anxiety Related Disorders (SCARED) - Child Version
기간: Measured at pre-treatment, post-treatment, and one month follow-up
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Measured at pre-treatment, post-treatment, and one month follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Golda Ginsburg, PhD, Johns Hopkins School of Medicine
간행물 및 유용한 링크
일반 간행물
- Ginsburg, G. S., Becker, K. D., Kingery, J.,and Nichols, T. (2008). Transporting CBT for childhood anxiety disorders into inner city school-based mental health clinics. Cognitive and Behavioral Practice, 15, 148-158.
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. .