Adaptation of REDCHIP Intervention for the Portuguese Context

The present Feasibility Randomized Controlled Trial (FRCT) aims to assess the acceptability and effectiveness of REDCHiP intervention, targeting parents of young children with T1D, followed in two major Portuguese hospitals. The objective of this trial is to evaluate (1) acceptability and feasibility by evaluating recruitment and retention rates, attendance throughout the sessions, and responses to parent satisfaction; (2) effectiveness by analyzing changes in parents' FH, diabetes distress (DD), emotional regulation (ER), resilient coping skills (RC), and anxiety and depression as well as changes in child glycemic outcomes (HbA1c, GMI, TBR, TIR, TAR) at three time points among participants allocated on intervention versus Treatment As Usual (TAU) group. Finally, (3) the investigators aim to qualitatively evaluate participant´s experiences and feedback regarding the REDHIP intervention through interviews.

NCT Number	NCT07201779
Lead Sponsor	ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida Collaborators: Hospital de Santa Maria, Portugal, Centro Hospitalar de Lisboa Central, Fundação para a Ciência e a Tecnologia, Nemours Children's Clinic
Conditions	Type 1 Diabetes
Enrollment	44 participants
Start Date	2026-04
Primary Completion	2026-04 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-10-01