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NCT07201779Not yet recruiting

Adaptation of REDCHIP Intervention for the Portuguese Context

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
44 (estimated)
First submitted
22 Sept 2025
Start date
1 Apr 2026
Primary completion date
30 Apr 2026
Lead sponsor
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
NCT number
NCT07201779

What you commit to

  • Study type: Interventional
  • Planned participants: 44
  • From 1 Apr 2026 to the primary completion date, 30 Apr 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Parents with severe psychiatric diagnosis;
  • Families of children with another severe chronic condition (e.g., chronic kidney disease and Crohn's disease);

Other

  • Parents who are not fluent in Portuguese.

Who the study is looking for

  • Primary caregivers must have a young child aged ≤ 8 years with a confirmed diagnosis of T1D for at least three months;
  • Young children must be using either an continuous subcutaneous insulin infusion (CSII) or multiple daily insulin injections (MDI) and continuous glucose monitoring (CGM) for daily T1D treatment;
  • Parents must have internet access and a computer, tablet or smartphone that connects to the internet.

Age in the registry: 1 year to 8 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.