A multi-site pilot randomized clinical trial of the Treatment and Education Approach for Childhood-onset Lupus (TEACH) program: study design and COVID-19 adaptations.

BACKGROUND: Childhood-onset Systemic Lupus Erythematosus (cSLE) is an autoimmune disease associated with fatigue, mood symptoms, and pain. Fortunately, these symptoms are potentially modifiable with psychological intervention such as cognitive-behavioral therapy (CBT). The Treatment and Education Approach for Childhood-onset Lupus (TEACH) program is a CBT intervention developed to target these symptoms for adolescents and young adults with cSLE. This pilot randomized controlled trial (RCT) aims to determine the feasibility and effect of TEACH for youth with cSLE. Adjustments to the study protocol following the COVID-19 pandemic are also described. METHODS: This two-arm multisite RCT will explore the feasibility (primary outcome) and effect (secondary outcome) of a remotely delivered TEACH protocol. Participants will be randomized to a six-week remotely delivered TEACH program plus medical treatment as usual (TAU) or TAU alone. We will include patients ages 12-22 years presenting to rheumatology clinics from six sites. Validated measures of fatigue, depressive symptoms, and pain will be obtained at baseline and approximately eight and 20 weeks later. Protocol adjustments were also made due to the COVID-19 pandemic, in collaboration with the investigative team, which included patients and caregivers. CONCLUSIONS: Findings from this multi-site RCT aim to document the feasibility of TEACH and provide an estimate of effect of a remotely delivered TEACH protocol on fatigue, depression, and pain symptoms in youth with cSLE as compared to standard medical treatment alone. This findings may positively impact clinical care for patients with cSLE. CLINICAL TRIALS: gov registration: NCT04335643.

Trauma e narrativa: o impacto da leucemia na infância / Trauma and narrative: the impact of leukemia in childhood

O presente artigo apresenta uma pesquisa que teve como objetivo investigar o impacto da leucemia infantil na subjetividade das crianças. O trabalho foi norteado pelo conceito psicanalítico de trauma principalmente em Sigmund Freud, Donald Winnicott e Sándor Ferenczi. Para escutar sobre as experiências das crianças internadas em tratamento para leucemia, foram realizadas entrevistas semiabertas no Hemorio (Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti). Uma análise qualitativa das narrativas evidencia os aspectos próprios do trauma, como o excesso, o desamparo, as invasões, o desmentido e a ameaça de morte. Assim, diante do impacto, resta a necessidade de elaboração: através do narrar, e do brincar.(AU)

This paper presents a research on the impact of infant leukemia on children's subjectivity. The work was guided by the psychoanalytic concept of trauma, as defined by Sigmund Freud, Donald Winnicott and Sándor Ferenczi. To listen to the experiences of children in treatment for leukemia, semi-open interviews were conducted at Hemorio (State Institute of Hematology Arthur de Siqueira Cavalcanti). A qualitative analysis of those narratives highlights the specific aspects of trauma, such as: the excess, the helplessness, the invasions, the denial and the threat of death. Thus, out of the impact, comes the need to elaborate: through narrating and playing.(AU)