University Psychiatric Clinics, University of Basel, Basel, Switzerland.
Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany.
J Child Psychol Psychiatry. 2024 Mar;65(3):316-327. doi: 10.1111/jcpp.13896. Epub 2023 Oct 10.
Conduct disorder (CD) and oppositional defiant disorder (ODD) both convey a high risk for maladjustment later in life and are understudied in girls. Here, we aimed at confirming the efficacy of START NOW, a cognitive-behavioral, dialectical behavior therapy-oriented skills training program aiming to enhance emotion regulation skills, interpersonal and psychosocial adjustment, adapted for female adolescents with CD or ODD.
A total of 127 girls were included in this prospective, cluster randomized, multi-center, parallel group, quasi-randomized, controlled phase III trial, which tested the efficacy of START NOW (n = 72) compared with standard care (treatment as usual, TAU, n = 55). All female adolescents had a clinical diagnosis of CD or ODD, were 15.6 (±1.5) years on average (range: 12-20 years), and were institutionalized in youth welfare institutions. The two primary endpoints were the change in number of CD/ODD symptoms between (1) baseline (T1) and post-treatment (T3), and (2) between T1 and 12-week follow-up (T4).
Both treatment groups showed reduced CD/ODD symptoms at T3 compared with T1 (95% CI: START NOW = -4.87, -2.49; TAU = -4.94, -2.30). There was no significant mean difference in CD/ODD symptom reduction from T1 to T3 between START NOW and TAU (-0.056; 95% CI = -1.860, 1.749; Hedge's g = -0.011). However, the START NOW group showed greater mean symptom reduction from T1 to T4 (-2.326; 95% CI = -4.274, -0.378; Hedge's g = -0.563). Additionally, secondary endpoint results revealed a reduction in staff reported aggression and parent-reported irritability at post assessment.
Although START NOW did not result in greater symptom reduction from baseline to post-treatment compared with TAU, the START NOW group showed greater symptom reduction from baseline to follow-up with a medium effect size, which indicates a clinically meaningful delayed treatment effect.
品行障碍（CD）和对立违抗性障碍（ODD）都预示着患者在以后的生活中存在适应不良的高风险，且女孩中此类障碍的研究较少。在这里，我们旨在确认 START NOW 的疗效，这是一种认知行为、以辩证行为治疗为导向的技能训练计划，旨在增强情绪调节技能、人际关系和心理社会适应能力，适用于患有 CD 或 ODD 的青春期女孩。
共有 127 名女孩参与了这项前瞻性、集群随机、多中心、平行组、半随机对照的 III 期试验，以测试 START NOW（n = 72）与标准护理（常规治疗，TAU，n = 55）相比的疗效。所有女性青少年均被临床诊断为 CD 或 ODD，平均年龄为 15.6（±1.5）岁（范围：12-20 岁），并被安置在青少年福利机构中。两个主要终点是：（1）从基线（T1）到治疗结束（T3），CD/ODD 症状数量的变化；（2）从 T1 到 12 周随访（T4），CD/ODD 症状数量的变化。
与 T1 相比，两个治疗组在 T3 时 CD/ODD 症状均减少（95%CI：START NOW = -4.87，-2.49；TAU = -4.94，-2.30）。与 TAU 相比，从 T1 到 T3，START NOW 治疗组的 CD/ODD 症状减轻没有显著的平均差异（-0.056；95%CI = -1.860，1.749；Hedge's g = -0.011）。然而，从 T1 到 T4，START NOW 组的平均症状减轻程度更大（-2.326；95%CI = -4.274，-0.378；Hedge's g = -0.563）。此外，次要终点结果显示，在评估后，工作人员报告的攻击性和父母报告的易怒性降低。
尽管 START NOW 与 TAU 相比，从基线到治疗后没有导致更大的症状减轻，但 START NOW 组从基线到随访的症状减轻程度更大，具有中等的治疗效果，这表明存在具有临床意义的延迟治疗效果。
