2025-525122-35-00招募中4 期
Attachment Development and Learning in ADHD: The Role of Dopamine.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Children’s instrumental responding to caregiver-related cues compared to neutral cues; children’s trust learning and support-seeking behavior; behavioral-based rating of children’s attachment representations and parental sensitivity; immediate affective relationship dynamics.
研究概览
简要总结
To investigate how methylphenidate (compared to placebo) influences attachment-related learning processes and behavior in children with ADHD.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- •Children aged 8-12 years, currently attending elementary school.
- •A prior diagnosis of ADHD, which is again confirmed in routine clinical care with a structured diagnostic interview (K-SADS; (Kaufman et al., 1997)) before the start of the PCT.
- •Initiation of pharmacological treatment with methylphenidate (MPH) within the past 0-12 months, in accordance with evidence-based Flemish/Dutch guidelines (Emmers et al., 2023; Zorgpad ADHD, n.d.), via a 5-week double-blind, placebo-controlled titration (PCT) procedure as implemented in routine clinical practice. During this PCT, the child was identified as a responder, and an optimal dose of short-acting MPH (SA-MPH) was established. Between completion of the PCT and study start, adjustments in dosage and/or formulation (e.g., switch to long-acting MPH) may have occurred, based on clinical evaluation of therapeutic (side) effects by the treating child psychiatrist at the ADHD clinic of UZ Leuven.
- •Fluency in Dutch of the child and its primary caregiver.
排除标准
- •Formal diagnosis of co-occurring autism spectrum disorder and/or major neurological disorders, as these conditions may involve distinct learning processes relating to attachment (Odent et al., 2021).
- •Use of non-stimulant psychopharmacological treatments (e.g., atomoxetine, antidepressants, antipsychotics, guanfacine, bupropion), with the exception of melatonin, to allow for a controlled comparison of attachment-related measures under stimulant medication versus no-medication conditions, without the potential confounding influence of other psychotropic agents.
- •Stimulant medication use (e.g., Ritalin, Equasym) less than 32 hours prior to testing at time points 1 or
- •Children will be asked to refrain from using stimulant medication for at least 32 hours before each testing session.
- •Current participation in any form of family therapy, mediation, or parenting program at the time of either testing session (T1 or T2), as such interventions may influence child and/or parent behavior and interaction patterns.
- •Participation in another interventional trial involving an investigational medicinal product (IMP) or device.
- •IQ below 70, as established through prior WISC-V-NL testing (David Wechsler, 2017).
结局指标
主要结局
Children’s instrumental responding to caregiver-related cues compared to neutral cues; children’s trust learning and support-seeking behavior; behavioral-based rating of children’s attachment representations and parental sensitivity; immediate affective relationship dynamics.
Children’s instrumental responding to caregiver-related cues compared to neutral cues; children’s trust learning and support-seeking behavior; behavioral-based rating of children’s attachment representations and parental sensitivity; immediate affective relationship dynamics.
次要结局
未报告次要终点
研究者
Karen Vertessen
Scientific
UZ Leuven
研究点 (1)
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