Protocol of Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP): A feasibility randomized controlled trial in the Portuguese context

Vasco Costa, Susana Patton, Sónia do Vale do Vale, Lurdes Sampaio, Catarina Limbert, Tânia Brandão

Abstract


Abstract: Type 1 diabetes (T1D) in early childhood presents unique challenges, especially for parents who are mainly responsible for T1D treatment. Fear of Hypoglycemia (FH) is a major concern, as
young children often cannot identify or communicate symptoms, increasing the risk of severe consequences. Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) is the only validated psychological intervention specifically developed to target parental FH in early childhood. This protocol outlines plans to translate, adapt and implement REDCHiP in Portugal. A Feasibility Randomized Controlled Trial (FRCT) will be conducted using a two-arm, open-label design and a mixed-method approach among parents of children up to 8 years old. Participants will be randomly allocated (1:1) to the intervention or treatment as usual (TAU) and assessed at baseline, postintervention, and three-month follow-up. Primary outcomes will focus on parental psychological adjustment, including FH and diabetes distress. Secondary outcomes will evaluate children’s Glycated Hemoglobin (HbA1c), via Glucose Management Indicator (GMI) and Blood Glucose Sample Test, and Time Below Range (TBR), Time In Range (TIR), and Time Above Range (TAR). Semi-structured interviews will explore participants’ experiences with this intervention. This study represents the first international adaptation and implementation of REDCHiP and the first evaluation of its feasibility and acceptability in a European context. Findings may inform the integration of culturally adapted psychological support and digital interventions into pediatric diabetes care.


Keywords


Protocol, Psychological intervention, REDCHiP, Parents, fear of hypoglycemia, Type 1 diabetes.

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References


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DOI: https://doi.org/10.14417/ap.2258

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