在临床和门诊环境中，针对有调节障碍的儿童，与常规护理相比，父母-婴儿心理疗法的疗效：作为 SKKIPPI 项目一部分的一项随机对照试验的研究方案。
Efficacy of parent-infant psychotherapy compared to care as usual in children with regulatory disorders in clinical and outpatient settings: study protocol of a randomised controlled trial as part of the SKKIPPI project.
机构信息
Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, University of Leipzig, Liebigstrasse 20a, 04103, Leipzig, Germany.
International Psychoanalytic University Berlin, Berlin, Germany.
出版信息
BMC Psychiatry. 2021 Feb 27;21(1):118. doi: 10.1186/s12888-021-03112-6.
BACKGROUND
The first years of life are a significant period for child development, when children are particularly sensitive and prone to crises. This early phase lays the foundation for healthy growth. Clinical assessment of psychological symptoms in early infancy and adequate treatment are both important in improving the diagnostic outcome and preventing later long-term developmental consequences. The most common psychological problems in the first 3 years of life are regulatory disorders. The aim of this trial is to investigate the efficacy of Parent-Infant Psychotherapy (PIP) for infants and young children (aged 0-36 months, diagnosed with at least one regulatory disorder) and their mothers, compared to care as usual (CAU).
METHODS
In this open multicentre randomised controlled trial, 160 mother-infant dyads are randomised to receive PIP or CAU for 6 weeks of intervention in clinical or outpatient (including home treatment) settings. The primary outcome is the maternal sensitivity (sensitivity scale of the Emotional Availability Scales (EAS)) after 6 weeks. Secondary outcomes include assessment of interaction, mental health problems, attachment, development, psychological factors, treatment adherence, health care system utilisation, and costs, after 6 weeks and 12 months.
DISCUSSION
This study will evaluate whether a manualised focus-based short-term psychodynamic psychotherapeutic intervention in mother-child dyads improves the care situation for families of children diagnosed with regulatory disorders, and helps prevent long-term psychopathologies. Assessment of the intervention in different settings will support the development of more tailored interventions for affected infants and their mothers.
TRIAL REGISTRATION
German Clinical Trial Register, ID: DRKS00017008 . Registered 03/20/2019.
背景
生命的头几年是儿童发展的重要时期，在此期间，儿童特别敏感且容易出现危机。这个早期阶段为健康成长奠定了基础。在婴儿早期对心理症状进行临床评估并进行充分治疗，对于改善诊断结果和预防后期长期发育后果都很重要。生命最初 3 年最常见的心理问题是调节障碍。本试验旨在研究母婴心理治疗（PIP）对婴儿和幼儿（0-36 月龄，至少被诊断出一种调节障碍）及其母亲的疗效，与常规护理（CAU）相比。
方法
在这项开放性多中心随机对照试验中，160 对母婴对被随机分配接受 PIP 或 CAU 治疗，在临床或门诊（包括家庭治疗）环境中进行 6 周的干预。主要结局是 6 周后母亲的敏感性（情感可用性量表（EAS）的敏感性量表）。次要结局包括在 6 周和 12 个月时评估互动、心理健康问题、依恋、发育、心理因素、治疗依从性、卫生保健系统利用和成本。
讨论
本研究将评估针对被诊断为调节障碍儿童的母子二人的基于手册的聚焦短期心理动力学心理治疗干预是否改善了家庭的护理状况，并有助于预防长期精神病理。在不同环境下对干预措施的评估将支持为受影响的婴儿及其母亲开发更具针对性的干预措施。
试验注册
德国临床试验注册处，ID：DRKS00017008。注册于 2019 年 3 月 20 日。
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