Child/Adolescent Anxiety Multimodal Treatment Study (CAMS)

儿童/青少年焦虑多模式治疗研究 (CAMS)

基本信息

项目摘要

DESCRIPTION (provided by applicant): This competing continuation of the six site Child/Adolescent Anxiety Multimodal Treatment Study (CAMS, U01MH64092), which is currently in year 3 of the 4 year award, is being submitted in response to PA-01-123 inviting collaborative research on Clinical Studies of Mental Disorders. Anxiety disorders are among the most common conditions affecting youth with point prevalence of 12-20%. The three most common childhood onset anxiety disorders, separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SP), routinely co-occur and cause clinically significant impairment in academic, social, and family functioning. Left untreated, they foretell persistent anxiety, major depression and substance abuse into adulthood. Hence, effective treatments for childhood-onset anxiety disorders promise to alleviate and perhaps to prevent morbidity and even mortality. In randomized controlled trials, members of our group have shown that cognitive-behavioral therapy (CBT) and the selective serotonin reuptake inhibitors (SSRIs) are effective for anxiety disorders in youth. To date there are no controlled trails comparing CBT and an SSRI, alone and in combination, to a suitable control condition in the same patient population. CAMS is a two phase, masked, randomized controlled trial for youth ages 7-17 years with SAD, SP and GAD. Phase I is a 12-week, acute efficacy study; subjects are randomized (2:2:2:1) to CBT, sertraline, their combination or pill placebo. Phase II involves a 6-month maintenance phase for Phase I responders. We employ manualized intervention and assessment protocols, including the assessment of adverse events, and state-of-the-art quality assurance procedures that insure uniform cross-site administration of the study protocol. All subjects are evaluated at all assessment points for both beneficial and adverse outcomes. Assessments include parent, child and clinician ratings; to preserve study blindness, the primary outcomes are assessed by blind independent evaluators. The proposed competing continuation, which builds on demonstrated feasibility in sample recruitment and retention, will extend CAMS for 24 months and expand the CAMS sample from 318 to 478 subjects to increase power (1) to precisely estimate effect size differences on the primary dependent measures and (2) to promote the identification of subgroup differences (moderator analyses) and mechanisms of treatment response (mediator analyses).
描述(由申请人提供):这项六中心儿童/青少年焦虑多模式治疗研究(CAMS,U01MH64092)的竞争性延续,目前处于 4 年奖的第 3 年,是为了响应 PA-01-123 邀请精神障碍临床研究合作研究而提交的。焦虑症是影响青少年的最常见疾病之一,发病率为 12-20%。三种最常见的儿童期发病的焦虑症,即分离焦虑症(SAD)、广泛性焦虑症(GAD)和社交恐惧症(SP),通常同时发生,并导致学术、社交和家庭功能的临床显着损害。如果不加以治疗,它们预示着成年后将持续存在焦虑、严重抑郁和药物滥用。因此,针对儿童期焦虑症的有效治疗有望减轻甚至预防发病率甚至死亡率。在随机对照试验中,我们小组的成员表明认知行为疗法(CBT)和选择性血清素再摄取抑制剂(SSRI)对青少年焦虑症有效。迄今为止,还没有对照试验将 CBT 和 SSRI 单独或联合使用与相同患者群体中合适的对照条件进行比较。 CAMS 是一项针对 7-17 岁患有 SAD、SP 和 GAD 青少年的两阶段、隐蔽、随机对照试验。 I 期是一项为期 12 周的急性疗效研究;受试者被随机(2:2:2:1)接受 CBT、舍曲林、它们的组合或安慰剂。第二阶段涉及第一阶段响应者为期 6 个月的维护阶段。我们采用手动干预和评估方案,包括不良事件的评估,以及确保研究方案的统一跨站点管理的最先进的质量保证程序。所有受试者均在所有评估点进行有益和不良结果的评估。评估包括家长、儿童和临床医生的评分;为了保持研究的盲目性,主要结果由盲人独立评估者进行评估。拟议的竞争性延续以样本招募和保留的可行性为基础,将 CAMS 延长 24 个月,并将 CAMS 样本从 318 名受试者扩大到 478 名受试者,以提高能力 (1) 精确估计主要相关测量的效应大小差异,(2) 促进亚组差异(调节分析)和治疗反应机制(调节分析)的识别。

项目成果

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ANNE MARIE ALBANO其他文献

ANNE MARIE ALBANO的其他文献

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{{ truncateString('ANNE MARIE ALBANO', 18)}}的其他基金

Child /adolescent anxiety multimodal treatment study
儿童/青少年焦虑多模式治疗研究
  • 批准号:
    6769343
  • 财政年份:
    2002
  • 资助金额:
    $ 29.59万
  • 项目类别:
Child /adolescent anxiety multimodal treatment study
儿童/青少年焦虑多模式治疗研究
  • 批准号:
    6663787
  • 财政年份:
    2002
  • 资助金额:
    $ 29.59万
  • 项目类别:
Child /adolescent anxiety multimodal treatment study
儿童/青少年焦虑多模式治疗研究
  • 批准号:
    6477696
  • 财政年份:
    2002
  • 资助金额:
    $ 29.59万
  • 项目类别:
Child /adolescent anxiety multimodal treatment study
儿童/青少年焦虑多模式治疗研究
  • 批准号:
    6935839
  • 财政年份:
    2002
  • 资助金额:
    $ 29.59万
  • 项目类别:
1/6-Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS)
1/6 儿童/青少年焦虑多模式扩展长期研究 (CAMELS)
  • 批准号:
    8135455
  • 财政年份:
    2001
  • 资助金额:
    $ 29.59万
  • 项目类别:
1/6-Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS)
1/6 儿童/青少年焦虑多模式扩展长期研究 (CAMELS)
  • 批准号:
    8700510
  • 财政年份:
    2001
  • 资助金额:
    $ 29.59万
  • 项目类别:
1/6-Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS)
1/6 儿童/青少年焦虑多模式扩展长期研究 (CAMELS)
  • 批准号:
    8530278
  • 财政年份:
    2001
  • 资助金额:
    $ 29.59万
  • 项目类别:
Child/Adolescent Anxiety Multimodal Treatment Study (CAMS)
儿童/青少年焦虑多模式治疗研究 (CAMS)
  • 批准号:
    7049841
  • 财政年份:
    2001
  • 资助金额:
    $ 29.59万
  • 项目类别:
1/6-Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS)
1/6 儿童/青少年焦虑多模式扩展长期研究 (CAMELS)
  • 批准号:
    7887531
  • 财政年份:
    2001
  • 资助金额:
    $ 29.59万
  • 项目类别:
1/6-Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS)
1/6 儿童/青少年焦虑多模式扩展长期研究 (CAMELS)
  • 批准号:
    8293396
  • 财政年份:
    2001
  • 资助金额:
    $ 29.59万
  • 项目类别:

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