Adaptation of REDCHIP Intervention for the Portuguese Context (NCT07201779) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Adaptation of REDCHIP Intervention for the Portuguese Context
44 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
1 Year – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Parents with severe psychiatric diagnosis;
. Families of children with another severe chronic condition (e.g., chronic kidney disease and Crohn's disease);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parents Fear of Hypoglycemia
Timeframe: From baseline to post-intervention (14-15 week)
2
Parents Diabetes Distress
Timeframe: From baseline to post-intervention (14-15 week)
3
Children Glycemic Outcomes
Timeframe: From baseline to post-intervention (14-15 week)
4
Children Glycemic Outcomes
Timeframe: From baseline to post-intervention (14-15 week)
5
Children Glycemic Outcomes
Timeframe: From baseline to post-intervention (14-15 week)
6
Children Glycemic Outcomes
Timeframe: From baseline to post-intervention (14-15 week)
7
Children Glycemic Outcomes
Timeframe: From baseline to post-intervention (14-15 week)
Trial details
NCT IDNCT07201779
SponsorISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida