Parent characteristics.

Attention-Deficit/Hyperactivity Disorder (ADHD) is defined by impairing levels of inattention and/or hyperactivity-impulsivity. It occurs in at least 5% of school age children and 2.5% of adults worldwide, and is associated with multiple negative outcomes throughout life. There is good evidence to support the efficacy of pharmacological treatment of individuals affected, and also of behavioural training for parents of children with ADHD, though the optimal focus and format to support change has yet to be established. This feasibility, parallel-group, randomised, controlled, pilot trial examined the feasibility of comparing two parenting programmes for families of school-aged children with ADHD. Parents of children aged 5–12 years with a clinical diagnosis of ADHD, referred to a regional integrated ADHD pathway, were randomly allocated (1:1 in permuted blocks of 4) either to a Parents InC or Incredible Years (IY) parenting group. The primary feasibility outcomes were recruitment and retention rates. The putative primary effectiveness outcome measure was Parenting Sense of Competence Scale (PSOC) and secondary outcome measures included the behavioural, physical, and emotional functioning of the child as well as health and ADHD symptoms of the parents at 12 (or 6 in final four participants) months post-randomisation. Process and economic evaluations were also included. We recruited 30/52 (58%) eligible participants (14 randomised to Parents InC, 16 to IY). Twenty-two participants (73%) provided follow-up quantitative data and 24 (80%) participated in qualitative interviews. PSOC scores were suggestive of greater improvement in Parents InC groups than IY groups. Power calculations suggest we will need to recruit 230 participants for a definitive RCT. Health economic analysis showed Parents InC had a lower per-group costs. Participant feedback on research procedures and methods was positive, and interviews and process evaluation provided a rich source of learning points to take forward into a future trial. Trial registration Clinical Trials, protocol registration system: NCT03832270.注意缺陷多动障碍（Attention-Deficit/Hyperactivity Disorder, ADHD）以显著受损的注意力不集中和/或多动-冲动症状为核心诊断特征，会对个体造成明显功能损害。全球范围内，至少5%的学龄儿童与2.5%的成人受该疾病影响，且其与个体终身的多种不良健康结局密切相关。现有充分证据证实，针对ADHD患者的药物治疗疗效确切，针对ADHD患儿家长的行为训练方案同样具有应用价值，但目前尚未明确支持行为改变的最优干预聚焦方向与实施形式。本项可行性平行组随机对照先导试验，旨在对比两种针对学龄期ADHD患儿家庭的家长干预方案的可行性。研究纳入经临床确诊为ADHD、年龄5~12岁的儿童家长，所有受试者均转诊至区域整合性ADHD诊疗路径，随后采用以4名受试者为单位的区组随机化方法，以1:1的比例将其分配至家长参与计划（Parents InC）组或精彩童年（Incredible Years, IY）家长干预组。本试验的首要可行性结局指标为招募率与随访保留率。预设的主要有效性结局指标为家长教养能力感量表（Parenting Sense of Competence Scale, PSOC），次要结局指标则包括儿童的行为、躯体与情绪功能，以及受试者随机分组后12个月（最终4名受试者则为6个月）时家长的健康状况与ADHD症状水平。此外本研究还纳入了过程评价与健康经济学评价环节。本研究共纳入52名符合入组标准的受试者中的30名，招募率为58%，其中14名被随机分配至Parents InC组，16名分配至IY组。最终有22名受试者（73%）提供了随访定量数据，24名受试者（80%）参与了质性访谈。PSOC评分结果显示，Parents InC组的干预后改善幅度优于IY组。效力检验分析提示，若要开展确证性随机对照试验（definitive RCT），需招募230名受试者。健康经济学分析结果显示，Parents InC组的单组干预成本更低。受试者对研究流程与方法的反馈积极，质性访谈与过程评价为后续试验的优化提供了丰富的经验参考。本试验已在临床试验注册系统完成注册，注册编号为NCT03832270。