UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
Great Ormond Street Hospital NHS Foundation Trust, London, UK.
Trials. 2021 Feb 11;22(1):132. doi: 10.1186/s13063-020-05003-9.
Mental health disorders in the context of long-term conditions in children and young people are currently overlooked and undertreated. Evidence-based psychological treatments for common childhood mental health disorders (anxiety, depression and disruptive behaviour disorders) have not been systematically evaluated in young people with epilepsy despite their high prevalence in this population. The aim of this multi-site randomised controlled trial is to determine the clinical and cost-effectiveness of adding a modular psychological intervention to usual care for the mental health disorders in comparison to assessment-enhanced usual care alone.
In total, 334 participants aged 3-18 years attending epilepsy services will be screened for mental health disorders with the Strengths and Difficulties Questionnaire (SDQ) and the diagnostic Development and Wellbeing Assessment (DAWBA). Those identified as having a mental health disorder and consenting to the trial will be randomised to either receive up to 22 sessions of the modular psychological intervention (MATCH-ADTC) delivered over the telephone over 6 months by non-mental health professionals in addition to usual care or to assessment-enhanced usual care alone. Outcomes will be measured at baseline, 6 months and 12 months post-randomisation. It is hypothesised that MATCH-ADTC plus usual care will be superior to assessment-enhanced usual care in improving emotional and behavioural symptoms. The primary outcome is the SDQ reported by parents at 6 months. Secondary outcomes include parent-reported mental health measures such as the Revised Children's Anxiety and Depression Scale, quality of life measures such as the Paediatric Quality of Life Inventory and physical health measures such as the Hague Seizure Severity Scale. Outcome assessors will be blinded to group assignment. Qualitative process evaluations and a health economic evaluation will also be completed.
This trial aims to determine whether a systematic and integrated approach to the identification and treatment of mental health disorders in children and young people with epilepsy is clinically and cost-effective. The findings will contribute to policies and practice with regard to addressing mental health needs in children and young people with other long-term conditions.
ISRCTN ISRCTN57823197 . Registered on 25 February 2019.
儿童和青少年长期疾病背景下的心理健康障碍目前被忽视且治疗不足。尽管癫痫青少年中这些障碍的患病率很高，但针对常见儿童心理健康障碍（焦虑、抑郁和破坏性行为障碍）的循证心理治疗尚未在该人群中进行系统评估。本多中心随机对照试验旨在确定与单独增强评估的常规护理相比，为癫痫患者的心理健康障碍添加模块化心理干预是否具有临床和成本效益。
共有 334 名 3-18 岁的癫痫患者将通过《长处与困难问卷》（SDQ）和《发育与幸福感评估》（DAWBA）筛查心理健康障碍。那些被确定为患有心理健康障碍并同意参加试验的患者将被随机分配到两种治疗组，即接受最多 22 节的电话心理干预（MATCH-ADTC），由非心理健康专业人员在 6 个月内提供，作为常规护理的附加内容，或仅接受增强评估的常规护理。在随机分组后 6 个月和 12 个月时进行结局评估。假设 MATCH-ADTC 联合常规护理在改善情绪和行为症状方面优于增强评估的常规护理。主要结局是父母在 6 个月时报告的 SDQ。次要结局包括父母报告的心理健康测量，如修订后的儿童焦虑和抑郁量表，生活质量测量，如儿科生活质量量表，以及身体健康测量，如 Hague 癫痫严重程度量表。结局评估者将对分组情况进行盲法评估。还将进行定性过程评估和健康经济评估。
本试验旨在确定在癫痫青少年中系统、综合的心理健康障碍识别和治疗方法是否具有临床和成本效益。研究结果将有助于制定政策和实践，以满足患有其他长期疾病的儿童和青少年的心理健康需求。
ISRCTN ISRCTN57823197。于 2019 年 2 月 25 日注册。
