A waitlist randomised control trial assessing the efficacy of the Unified Protocol for the Treatment of Emotional Disorders in children and adolescents with chronic medical conditions who experience depression and anxiety

Murdoch Children's Research Institute0 个研究点目标入组 60 人开始时间: 2024年2月8日最近更新: 2024年8月19日

适应症

试验速览

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•Inclusion criteria are as follows:
•a.Have a CMC, defined as any medical condition where the child/adolescent have regular appointments or is seen every 6 months, and has emotional symptoms associated with their medical condition or impacting their medical condition (e.g., treatment adherence). Examples of CMC include asthma, congenital heart disease, diabetes, epilepsy, inflammatory bowel disease, juvenile idiopathic arthritis, and sickle cell disease.
•b.Score above the high-risk clinical range (greater than or equal to 65) for any of the subscales on the Revised Child Anxiety and Depression Scale (RCADS), to indicate clinically concerning levels of depression and anxiety. This will be based on both parent-report and self-reported outcomes on the RCADS.
•c. Young person and one parent will need to have sufficient English to complete the protocol without an interpreter. This is because most of the measures used in the project are only available in the English language, and the UP-C/A has not been validated in other languages.

•Exclusion criteria are as follows:
•a.Children/adolescents with a CMC where significant medical deterioration is expected and children in palliative care. Rationale: Most children within this high-risk group may be experiencing a complex array of symptoms and potentially be exposed to complex treatment regimens. We are hence excluding this group to limit the effects of these potential confounding factors on the intervention outcomes.
•b.Participants taking psychotropic medication, who are not on a stable dose for the 8 weeks prior to starting the study. Rationale: Since change in psychotropic medication can be associated with sporadic changes in mood and behaviour, we are excluding this group to reduce risk of having our treatment effects confounded by the effect of such medications.
•c.Children with co-morbid somatisation, eating disorders, significant intellectual disability (suspected or confirmed IQ <70), bipolar disorder, recent psychiatric hospitalization, or severe suicidal ideation or treatment-interfering substance abuse. Rationale: We are excluding this group because these conditions sometimes increased risk of/overlap with anxiety and depression symptoms and pose a high risk of confounding our measurements on these outcomes.

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