McGovern Ruth, Stamp Elaine, Javanbakht Mehdi, McColl Elaine, Hickman Matthew, Kaner Eileen
1Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.
2School of Social and Community Medicine, University of Bristol, Bristol, UK.
Pilot Feasibility Stud. 2018 Jun 9;4:111. doi: 10.1186/s40814-018-0305-5. eCollection 2018.
Research estimates that 30% of children under the age of 16 years in the UK live with at least one parent with an alcohol use disorder (AUD). Parental AUDs are associated with adverse childhood experiences and poorer outcomes for children. The PAReNTS (Promoting Alcohol Reduction in Non-Treatment Seeking parents) trial aims to examine the feasibility and acceptability of a randomised controlled trial of brief alcohol interventions to reduce parental alcohol misuse.
The cluster randomised controlled trial will be conducted within early help family support and children's social care services in three local authorities in the North East of England: Newcastle, Durham and North Tyneside. All eligible parents the caseloads of participating practitioners will be screened for an AUD using the Alcohol Use Disorder Identification Test - Consumption (AUDIT-C) screening tool by the social care practitioners within routine appointments. All parents who score 5 or more on the AUDIT-C will be invited to participate in the trial. Consenting participants will complete a baseline questionnaire before receiving one of three randomised interventions: (i) healthy lifestyle leaflet (control intervention); (ii) a brief alcohol advice intervention delivered by the social care practitioner plus healthy lifestyle leaflet; (iii) a brief alcohol advice intervention delivered by the social care practitioner, healthy lifestyle leaflet plus a 40-min behaviour change intervention with an optional review session delivered by the local alcohol service. Follow-up data will be collected 6 and 12 months post recruitment. A linked qualitative study will explore participating parent and practitioner views on the acceptability of trial processes and interventions.
The PAReNTS trial will provide a robust estimate of recruitment, retention and consent rates in order to inform the design of a future definitive study examining the effectiveness and cost-effectiveness of alcohol screening and brief interventions to reduce parental AUDs within vulnerable families.
ISRCTN registry ISRCTN60291091; protocol version 2; 17.10.2016.
研究估计，在英国，16岁以下儿童中有30%至少与一位患有酒精使用障碍（AUD）的父母生活在一起。父母的酒精使用障碍与儿童期不良经历以及儿童较差的结局相关。“父母”（促进未寻求治疗的父母减少酒精摄入）试验旨在检验一项简短酒精干预随机对照试验的可行性和可接受性，以减少父母的酒精滥用。
这项整群随机对照试验将在英格兰东北部三个地方当局的早期帮助家庭支持和儿童社会护理服务中进行：纽卡斯尔、达勒姆和北泰恩赛德。参与的从业者所负责的所有符合条件的父母将在常规预约时由社会护理从业者使用酒精使用障碍识别测试-消费量（AUDIT-C）筛查工具进行酒精使用障碍筛查。所有在AUDIT-C上得分5分或更高的父母将被邀请参加试验。同意参与的参与者将在接受三种随机干预之一之前完成一份基线问卷：（i）健康生活方式宣传册（对照干预）；（ii）由社会护理从业者提供的简短酒精建议干预加健康生活方式宣传册；（iii）由社会护理从业者提供的简短酒精建议干预、健康生活方式宣传册加40分钟行为改变干预以及由当地酒精服务机构提供的可选复查环节。招募后6个月和12个月将收集随访数据。一项相关的定性研究将探讨参与的父母和从业者对试验过程和干预措施可接受性的看法。
“父母”试验将对招募率、保留率和同意率进行可靠估计，以便为未来一项确定性研究的设计提供信息，该研究将考察酒精筛查和简短干预在减少弱势家庭中父母酒精使用障碍方面的有效性和成本效益。
国际标准随机对照试验编号ISRCTN60291091；方案版本2；2016年10月17日。
