PDF(Pubmed)
Abstract：
OBJECTIVE: We sought to understand the influence of recurrent assessments on the behaviour of children and caregivers in a 2-year study of an agricultural livelihood intervention.
METHODS: This study used qualitative exit interviews from caregivers in the control arm of a large, cluster-randomised control trial, Shamba Maisha.
METHODS: The study was conducted in Western Kenya and involved 12 health facilities between 2016 and 2019.
METHODS: Participants were 99 caregivers in the control arm who had a child that was 6-36 months in age at the start of the study.
METHODS: Intervention participants within Shamba Maisha received an irrigation pump, farming lessons and a microloan. Control participants received no intervention but were offered the intervention after completing the 2-year study.
RESULTS: Despite receiving no formal benefits, control caregivers reported improved mental health and enhanced knowledge of their child\'s health compared with the beginning of the study and reported changes in the child\'s play and diet that they attributed to participation in study assessments. Caregivers in the control arm attributed their changed behaviour to recurrent questioning, instrumental support, interactions with study staff and increased health knowledge.
CONCLUSIONS: Recurrent assessments altered participant behaviour, which may have made inference of the intervention\'s impact more difficult. In designing future, such studies with intervention and control arms, a trade-off between the gains in statistical power provided by recurrent visits and the avoidance of alterations in participants\' behaviour that could affect responses to assessments must be considered when deciding on the number of visits for assessment.
BACKGROUND: NCT03170986; NCT02815579.
METHODS: This study used qualitative exit interviews from caregivers in the control arm of a large, cluster-randomised control trial, Shamba Maisha.
METHODS: The study was conducted in Western Kenya and involved 12 health facilities between 2016 and 2019.
METHODS: Participants were 99 caregivers in the control arm who had a child that was 6-36 months in age at the start of the study.
METHODS: Intervention participants within Shamba Maisha received an irrigation pump, farming lessons and a microloan. Control participants received no intervention but were offered the intervention after completing the 2-year study.
RESULTS: Despite receiving no formal benefits, control caregivers reported improved mental health and enhanced knowledge of their child\'s health compared with the beginning of the study and reported changes in the child\'s play and diet that they attributed to participation in study assessments. Caregivers in the control arm attributed their changed behaviour to recurrent questioning, instrumental support, interactions with study staff and increased health knowledge.
CONCLUSIONS: Recurrent assessments altered participant behaviour, which may have made inference of the intervention\'s impact more difficult. In designing future, such studies with intervention and control arms, a trade-off between the gains in statistical power provided by recurrent visits and the avoidance of alterations in participants\' behaviour that could affect responses to assessments must be considered when deciding on the number of visits for assessment.
BACKGROUND: NCT03170986; NCT02815579.
摘要：
目的：在一项为期2年的农业生计干预研究中，我们试图了解反复评估对儿童和照顾者行为的影响。
方法：这项研究使用了大型，集群随机对照试验，ShambaMaisha.
方法：该研究在肯尼亚西部进行，并于2016年至2019年期间涉及12个医疗机构。
方法：参与者是对照组的99名护理人员，他们在研究开始时有一个6-36个月大的孩子。
方法：ShambaMaisha内的干预参与者接受了灌溉泵，农业课程和小额贷款。对照组参与者没有接受干预，但在完成为期2年的研究后接受了干预。
结果：尽管没有获得正式福利，与研究开始时相比，对照组看护者报告说，他们的心理健康得到改善，对孩子健康的了解也得到了提高，并报告了孩子游戏和饮食的变化，这归因于他们参与了研究评估。控制臂的护理人员将他们改变的行为归因于反复的询问，仪器支持，与研究人员的互动和增加健康知识。
结论：反复评估改变了参与者的行为，这可能使推断干预的影响变得更加困难。在设计未来时，这种干预和控制武器的研究，在决定评估的访问次数时，必须考虑反复访问提供的统计能力的增益与避免可能影响评估反应的参与者行为改变之间的权衡。
背景：NCT03170986;NCT02815579。
方法：这项研究使用了大型，集群随机对照试验，ShambaMaisha.
方法：该研究在肯尼亚西部进行，并于2016年至2019年期间涉及12个医疗机构。
方法：参与者是对照组的99名护理人员，他们在研究开始时有一个6-36个月大的孩子。
方法：ShambaMaisha内的干预参与者接受了灌溉泵，农业课程和小额贷款。对照组参与者没有接受干预，但在完成为期2年的研究后接受了干预。
结果：尽管没有获得正式福利，与研究开始时相比，对照组看护者报告说，他们的心理健康得到改善，对孩子健康的了解也得到了提高，并报告了孩子游戏和饮食的变化，这归因于他们参与了研究评估。控制臂的护理人员将他们改变的行为归因于反复的询问，仪器支持，与研究人员的互动和增加健康知识。
结论：反复评估改变了参与者的行为，这可能使推断干预的影响变得更加困难。在设计未来时，这种干预和控制武器的研究，在决定评估的访问次数时，必须考虑反复访问提供的统计能力的增益与避免可能影响评估反应的参与者行为改变之间的权衡。
背景：NCT03170986;NCT02815579。
