Adaptation of REDCHIP Intervention for the Portuguese Context

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.

Conditions

• Type 1 Diabetes

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

Sponsors & Collaborators

• Hospital de Santa Maria, Portugal

  collaborator OTHER

• Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisboa

  collaborator UNKNOWN

• Fundação para a Ciência e a Tecnologia

  collaborator OTHER

• Nemours Children's Clinic

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Vasco V Costa, MD · William James Center for Research (ISPA)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2026-04-30

Completion

2026-12-31