对抑郁症状加重的青少年开展的一项基于学校的抑郁症预防项目的评估：一项随机对照试验的研究方案
Evaluation of a school-based depression prevention program among adolescents with elevated depressive symptoms: study protocol of a randomized controlled trial.
作者信息
de Jonge-Heesen Karlijn W J, van Ettekoven Kim M, Rasing Sanne P A, Liempd Farina H J Oprins-van, Vermulst Ad A, Engels Rutger C M E, Creemers Daan H M
机构信息
GGZ Oost Brabant, P.O. Box 3, 5427 ZG, Boekel, The Netherlands.
Utrecht University, P.O. Box 80125, 3508 TC, Utrecht, The Netherlands.
出版信息
BMC Psychiatry. 2016 Nov 16;16(1):402. doi: 10.1186/s12888-016-1119-8.
BACKGROUND
Adolescents are at risk of developing depressive symptoms. Given the prevalence, recurrence and negative consequences of adolescent depression, it is crucial to implement prevention programs for high-risk adolescents. Prevention programs at an indicated level have shown to be successful in reducing depressive symptoms in adolescents. This study will evaluate the (cost)effectiveness of the prevention program 'Op Volle Kracht (OVK 2.0)' for adolescents with elevated depressive symptoms.
METHODS
We will perform a Randomized Controlled Trial (RCT) with an intervention and control condition to test the effectiveness of an indicated prevention program aimed at depression in adolescents. Adolescents in their second year of secondary education (11-15 year) will be screened for depressive symptoms. Those with heightened levels of depressive symptoms (CDI-2 ≥ 14) will be randomly assigned to the intervention (N = 80) or control group (N = 80). The participants in the intervention condition will receive a prevention program comprising eight meetings of 60 min each. The participants in the control condition will receive psycho-educational information. All participants and their parents will complete assessment at baseline, post-intervention, and 6-, 12- and 24- month follow-up. Primary outcome will be depressive symptoms. Additionally, the present study will identify mechanisms that mediate and moderate the program effects and test the effect of OVK 2.0 on secondary outcomes.
DISCUSSION
This paper describes a study designed to screen adolescents for depressive symptoms and offer them a prevention program to prevent the onset of depressive symptomatology. Adolescents in the intervention condition are expected to show lower levels of depressive symptoms at 12 month follow-up compared to adolescents in the control condition. If OVK 2.0 proves to be effective, the screening and intervention program could be implemented in schools on a large scale.
TRIAL REGISTRATION
Dutch Trial Register NTR5725 . Date registered: 11 of March 2016.
背景
青少年有出现抑郁症状的风险。鉴于青少年抑郁症的患病率、复发率及其负面后果，为高危青少年实施预防项目至关重要。针对特定人群的预防项目已被证明在减轻青少年抑郁症状方面是成功的。本研究将评估“全力出击（OVK 2.0）”预防项目对抑郁症状加重的青少年的（成本）效益。
方法
我们将进行一项随机对照试验（RCT），设置干预组和对照组，以测试针对青少年抑郁症的特定预防项目的有效性。对初中二年级（11 - 15岁）的青少年进行抑郁症状筛查。抑郁症状水平较高（儿童抑郁量表第二版[CDI - 2]≥14）的青少年将被随机分配到干预组（N = 80）或对照组（N = 80）。干预组的参与者将接受一个预防项目，包括八次每次60分钟的课程。对照组的参与者将接受心理教育信息。所有参与者及其父母将在基线、干预后以及6个月、12个月和24个月随访时完成评估。主要结局将是抑郁症状。此外，本研究将确定介导和调节项目效果的机制，并测试OVK 2.0对次要结局的影响。
讨论
本文描述了一项旨在筛查青少年抑郁症状并为他们提供预防项目以防止抑郁症状发作的研究。预计干预组的青少年在12个月随访时的抑郁症状水平低于对照组的青少年。如果OVK 2.0被证明是有效的，筛查和干预项目可在学校大规模实施。
试验注册
荷兰试验注册库NTR5725。注册日期：2016年3月11日。
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