Verhees Martine W F T, Ceulemans Eva, Bakermans-Kranenburg Marian J, van IJzendoorn Marinus H, de Winter Simon, Bosmans Guy
Parenting and Special Education Research Unit, KU Leuven, Leopold Vanderkelenstraat 32, 3000, Leuven, Belgium.
Quantitative Psychology and Individual Differences Research Unit, KU Leuven, Tiensestraat 102, 3000, Leuven, Belgium.
Trials. 2017 Jul 14;18(1):326. doi: 10.1186/s13063-017-2077-2.
Lack of trust in parental support is a transdiagnostic risk factor for the development of psychological problems throughout the lifespan. Research suggests that children's cognitive attachment representations and related information processing biases could be an important target for interventions aiming to build trust in the parent-child relationship. A paradigm that can alter these biases and increase trust is that of Cognitive Bias Modification (CBM), during which a target processing bias is systematically trained. Trust-related CBM training effects could possibly be enhanced by oxytocin, a neuropeptide that has been proposed to play an important role in social information processing and social relationships. The present article describes the study protocol for a double-blind randomized controlled trial (RCT) aimed at testing the individual and combined effects of CBM training and oxytocin administration on trust in maternal support.
METHODS/DESIGN: One hundred children (aged 8-12 years) are randomly assigned to one of four intervention conditions. Participants inhale a nasal spray that either contains oxytocin (OT) or a placebo. Additionally, they receive either a CBM training aimed at positively modifying trust-related information processing bias or a neutral placebo training aimed to have no trust-related effects. Main and interaction effects of the interventions are assessed on three levels of trust-related outcome measures: trust-related interpretation bias; self-reported trust; and mother-child interactional behavior. Importantly, side-effects of a single administration of OT in middle childhood are monitored closely to provide further information on the safety of OT administration in this age group.
The present RCT is the first study to combine CBM training with oxytocin to test for individual and combined effects on trust in mother. If effective, CBM training and oxytocin could be easily applicable and nonintrusive additions to interventions that target trust in the context of the parent-child relationship.
ClinicalTrials.gov, ID: NCT02737254 . Registered on 23 March 2016.
对父母支持缺乏信任是一生中出现心理问题的一个跨诊断风险因素。研究表明，儿童的认知依恋表征及相关信息加工偏差可能是旨在建立亲子关系信任的干预措施的重要目标。一种能够改变这些偏差并增强信任的范式是认知偏差修正（CBM），在此过程中会系统地训练目标加工偏差。催产素可能会增强与信任相关的CBM训练效果，催产素是一种神经肽，已被认为在社会信息加工和社会关系中发挥重要作用。本文描述了一项双盲随机对照试验（RCT）的研究方案，旨在测试CBM训练和催产素给药对母亲支持信任的个体和联合效应。
方法/设计：100名儿童（8至12岁）被随机分配到四种干预条件之一。参与者吸入一种鼻喷雾剂，其要么含有催产素（OT），要么含有安慰剂。此外，他们要么接受旨在积极修正与信任相关信息加工偏差的CBM训练，要么接受旨在不产生与信任相关效应的中性安慰剂训练。在与信任相关的三个层面的结果测量指标上评估干预措施的主要效应和交互效应：与信任相关的解释偏差；自我报告的信任；以及母子互动行为。重要的是，密切监测童年中期单次给予OT的副作用，以提供关于该年龄组OT给药安全性的更多信息。
本RCT是第一项将CBM训练与催产素相结合以测试对母亲信任的个体和联合效应的研究。如果有效，CBM训练和催产素可以很容易地应用于针对亲子关系中信任的干预措施，且是非侵入性的补充。
ClinicalTrials.gov，标识符：NCT02737254。于2016年3月23日注册。
