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NOT YET RECRUITING
NCT07201779
NA

Adaptation of REDCHIP Intervention for the Portuguese Context

Sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

View on ClinicalTrials.gov

Summary

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.

Official title: Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) -A Feasibility Randomized Controlled Trial in the Portuguese Context

Key Details

Gender

All

Age Range

1 Year - 8 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2026-04

Completion Date

2026-12

Last Updated

2025-10-01

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

REDCHiP

REDCHIP comprises 10 telehealth group sessions for parents of young children with T1D, is grounded in Cognitive Behavioral Therapy (CBT) principles, and is designed to address parents FH, and their avoidant coping behaviors related to FH. Sessions also focus on strengthening parents' coping strategies associated with T1D management and helping them to reduce feelings of diabetes distress.

OTHER

Treatment As Usual Control Group

Participants will receive their treatment as usual in medical appointments