ABSTRACT

Objective

This pilot randomised controlled trial evaluated the acceptability and feasibility of a psychological intervention to manage severe irritability in children and adolescents.

Methods

Children with severe irritability (9–14 years; 42% male) were randomised to receive six sessions of Collaborative & Proactive Solutions (CPS) or usual clinical care. The primary outcome was acceptability and feasibility of the intervention (participant enrollment, drop-out, intervention session attendance). Key secondary outcomes assessed 4-month post-randomisation included child irritability, quality of life, executive functioning, parent mental health and family functioning.

Results

Twelve children enrolled in the study (52% uptake). All participants in the CPS group attended ≥2 intervention sessions, and one participant in the usual care group was lost to follow-up. Compared to usual care, the CPS group had improvements in child irritability (Effect Size (ES): −0.4), quality of life (ES: 0.4), executive functioning (ES: −0.4), and family functioning (ES: −0.7).

Conclusion

It is acceptable and feasible to deliver CPS to severely irritable children and adolescents. Preliminary evidence suggests this non-pharmacological intervention improves important areas of functioning for severely irritable children.

Trial registration

The trial was prospectively registered on 11 October 2017 with the Australian New Zealand Clinical Trials Registry (www.anzctr.org.au: ACTRN12617001445369).

中文翻译：

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与常规护理相比，协作和主动解决方案治疗儿童和青少年易怒：一项试点随机对照试验

摘要

客观的

该试点随机对照试验评估了心理干预以管理儿童和青少年严重易怒的可接受性和可行性。

方法

患有严重易怒的儿童（9-14 岁；42% 男性）被随机分配接受六次协作和主动解决方案 (CPS) 或常规临床护理。主要结果是干预的可接受性和可行性（参与者注册、退出、干预会议出席）。随机分组后 4 个月评估的主要次要结果包括儿童易怒、生活质量、执行功能、父母心理健康和家庭功能。

结果

12 名儿童参加了这项研究（52% 的吸收）。CPS 组的所有参与者都参加了≥2 次干预会议，常规护理组的一名参与者失访。与常规护理相比，CPS 组在儿童易怒（影响大小（ES）：-0.4）、生活质量（ES：0.4）、执行功能（ES：-0.4）和家庭功能（ES：-0.7 ）方面有所改善）。

结论

向严重易怒的儿童和青少年提供 CPS 是可以接受和可行的。初步证据表明，这种非药物干预可以改善严重易怒儿童的重要功能领域。

试用注册

该试验于 2017 年 10 月 11 日在澳大利亚新西兰临床试验注册中心 (www.anzctr.org.au: ACTRN12617001445369) 进行了前瞻性注册。