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Protocol for a randomized control trial of the caregiver support intervention with Syrian refugees in Lebanon
Trials ( IF 2.0 ) Pub Date : 2020-03-18 , DOI: 10.1186/s13063-020-4175-9
Kenneth E. Miller , Maguy Arnous , Fadila Tossyeh , Alexandra Chen , Ioannis Bakolis , Gabriela V. Koppenol-Gonzalez , Nayla Nahas , Mark J. D. Jordans

There is evidence that chronic stress negatively impacts parenting among refugees and other war-affected communities. Persistent parental stress and distress may lead to unresponsive, anxious, or overly harsh parenting and a corresponding increase in emotional and behavior problems among children. Most parenting interventions emphasize the acquisition of knowledge and skills; however, this overlooks the deleterious effects of chronic stress on parenting. The Caregiver Support Intervention (CSI) aims to strengthen quality of parenting skills by lowering stress and improving psychosocial wellbeing among refugee caregivers of children aged 3–12 years, while also increasing knowledge and skills related to positive parenting. The CSI is a nine-session psychosocial group intervention delivered by non-specialist providers. It is intended for all adult primary caregivers of children in high-adversity communities, rather than specifically targeting caregivers already showing signs of elevated distress. The primary objective of this study is to assess the effectiveness of the CSI through a parallel group randomized controlled study with Syrian refugee families in North Lebanon. Participants will be primary caregivers of children aged 3–12 years, with one index child per family. Families will be randomized to the CSI or a waitlist control group. A total of 240 families (480 caregivers) will be recruited into the study. Randomization will be at the family level, and CSI groups will be held separately for women and men. The study will be implemented in two waves. Outcomes for both arms will be assessed at baseline, post-intervention, and at a 3-month follow-up. The primary outcome is quality of parenting skills. Secondary outcomes include parental warmth and sensitivity, harsh parenting, parenting knowledge, and child psychosocial wellbeing. Putative mediators of the CSI on parenting are caregiver stress, distress, psychosocial wellbeing, and stress management. This trial may establish the CSI as an effective intervention for strengthening parenting in families living in settings of high adversity, particularly refugee communities. International Society for the Registration of Clinical Trials, ISRCTN22321773. Registered on 5 August 2019

中文翻译:

护理人员对黎巴嫩叙利亚难民进行干预的随机对照试验议定书

有证据表明,长期的压力对难民和其他受战争影响的社区的养育方式产生了负面影响。持续的父母压力和困扰可能会导致父母反应迟钝,焦虑或过分苛刻,并相应增加儿童的情绪和行为问题。大多数育儿干预措施都强调知识和技能的获得。然而,这忽略了长期压力对育儿的有害影响。照料者支持干预(CSI)旨在通过降低3-12岁儿童的照料者的压力并改善其心理社会福利来提高育儿技能的质量,同时还增加与积极育儿有关的知识和技能。CSI是由非专家提供者提供的为期九次的社会心理团体干预。它适用于高危社区儿童的所有成人主要照顾者,而不是专门针对已经显示出苦恼加剧迹象的照顾者。这项研究的主要目的是通过与北黎巴嫩的叙利亚难民家庭进行的平行小组随机对照研究,评估CSI的有效性。参加者将是3至12岁儿童的主要照顾者,每个家庭有一名索引儿童。家庭将被随机分配到CSI或候补名单对照组。总共240个家庭(480个照顾者)将被纳入研究。随机化将在家庭一级进行,而CSI小组将分别针对男女举行。这项研究将分两次进行。两组的结果将在基线,干预后和3个月的随访中进行评估。主要结果是育儿技能的质量。次要结果包括父母的温暖和敏感度,苛刻的父母养育,父母的养育知识以及儿童的心理健康状况。CSI在养育子女方面的推定调解人是照料者压力,困扰,心理社会福利和压力管理。该试验可以将CSI确立为有效干预措施,以加强生活在高逆境中的家庭,特别是难民社区中的养育子女。国际临床试验注册协会,ISRCTN22321773。于2019年8月5日注册 和压力管理。该试验可以将CSI确立为有效干预措施,以加强生活在高逆境中的家庭,特别是难民社区中的养育子女。国际临床试验注册协会,ISRCTN22321773。于2019年8月5日注册 和压力管理。该试验可以将CSI确立为有效干预措施,以加强生活在高逆境中的家庭,特别是难民社区中的养育子女。国际临床试验注册协会,ISRCTN22321773。于2019年8月5日注册
更新日期:2020-03-19
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