Family systemic psychosocial support for at-risk adolescents in Lebanon: study protocol for a multi-site randomised controlled trial.
Family systemic psychosocial support for at-risk adolescents in Lebanon: study protocol for a multi-site randomised controlled trial.
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在以逆境为特征的社区中成长的青少年面临着心理健康和福祉不良的多种风险因素。目前缺乏关于预防和治疗这一人群心理困扰的有效方法的研究，特别是在人道主义背景下。家庭环境和家庭支持的强大影响是众所周知的;然而，很少在这种环境中制定或评估针对家庭的方法。我们制定了一个简短的家庭系统的心理社会支持干预措施，通过现有的儿童保护系统与非专业调解人提供。本文概述了在黎巴嫩进行的干预随机对照试验的研究方案。我们将进行一项单盲混合有效性-实施多中心随机对照试验，将当地开发的系统性家庭干预与居住在黎巴嫩北部和贝卡省脆弱地区的家庭（包括叙利亚、巴勒斯坦和黎巴嫩背景的家庭）的等待名单对照组进行比较。将在基线（T0）和干预后（T1）以及治疗组3个月随访（T2）时评估一系列家庭、青少年和护理人员措施的结果。家庭将有资格参加试验，如果他们被执行组织确定为儿童保护问题的中高风险，并且有一个或多个12-17岁的青少年在自我报告简要筛选工具上表现出显著的心理困扰。家庭将被随机分配到一个治疗或候补名单控制条件。在研究完成后，轮候册上的家庭将获得一个小组版本的计划，以便我们评估这种模式的可行性、可接受性和干预效果的初步迹象。主要结局是随着时间的推移，总体抑郁报告的心理困扰减少，干预后（T1）作为主要终点。次要结果包括家庭功能，心理健康和情绪调节困难。次要结果包括父母教养方式、家庭功能、心理困扰和情绪调节困难。这项试验将首次评估在黎巴嫩使用的家庭系统性心理社会支持干预措施的有效性，对该年龄段使用系统性、低成本、非专家干预措施具有重要意义。当地登记处：黎巴嫩共和国公共卫生部国家精神卫生方案。于2021年10月19日注册的黎巴嫩临床试验注册中心LBCTR 2021104870。于2021年10月13日注册全球注册中心：ISRCTN ISRCTN 13751677。于2021年11月1日注册
Adolescents growing up in communities characterised by adversity face multiple risk factors for poor mental health and wellbeing. There is currently a scarcity of research on effective approaches for preventing and treating psychological distress in this population, particularly in humanitarian settings. The powerful impact of the home environment and family support is well known; however, approaches targeting the family are seldom developed or evaluated in such settings. We developed a brief family systemic psychosocial support intervention to be delivered through existing child protection systems with non-specialist facilitators. This paper outlines the study protocol for a randomised controlled trial of the intervention in Lebanon. We will conduct a single-blind hybrid effectiveness-implementation multi-site RCT comparing the locally developed systemic family intervention to a waitlist control group for families residing in vulnerable regions in North Lebanon and Beqaa governorates (including families of Syrian, Palestinian, and Lebanese backgrounds). Outcomes on a range of family, adolescent, and caregiver measures will be assessed at baseline (T0) and post-intervention (T1), and at a 3-month follow-up for the treatment arm (T2). Families will be eligible for the trial if they are identified by implementing organisations as being medium-to-high risk for child protection concerns and have one or more adolescent aged 12–17 who demonstrates significant psychological distress on a self-report brief screening tool. Families will be randomly assigned to a treatment or a waitlist control condition. Families in the waitlist condition will receive a group version of the programme after completion of the study, to allow us to assess feasibility, acceptability, and preliminary indications of intervention effects of this modality. The primary outcome is reduction in overall adolescent-reported psychological distress over time, with post-intervention (T1) as the primary endpoint. Secondary adolescent-reported outcomes include family functioning, psychosocial wellbeing, and emotional regulation difficulties. Secondary caregiver-reported outcomes include parenting style, family functioning, psychological distress, and emotional regulation difficulties. This trial will provide the first assessment of the effectiveness of the family systemic psychosocial support intervention for use in Lebanon, with important implications for the use of systemic, low-cost, non-specialist interventions for this age range. Local registry: National Mental Health Program, Ministry of Public Health, Lebanese Republic. Registered on 19 October 2021 Lebanese Clinical Trial Registry LBCTR2021104870. Registered on 13 October 2021 Global registry: ISRCTN ISRCTN13751677. Registered on 1 November 2021
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