Adaptation of REDCHIP Intervention for the Portuguese Context

NCT07201779 | Not Yet Recruiting

• 1 other identifier: 114/24 and Inv 631
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

REDCHiP; Portuguese Context; Protocol; Psychological Interventions; Parents; Young Children; Type 1 Diabetes; Telehealth

Outcome Measures

Primary Outcomes (7)

• Parents Fear of Hypoglycemia

  Parents Fear of Hypoglycemia will be collected trough: The Hypoglycemia Fear Survey - Parents (HFS-P), 18-item self-report measure and comprises a total score and two subscales: Behavior and Worry.

  From baseline to post-intervention (14-15 week)

• Parents Diabetes Distress

  Parents Diabetes Distress will be evaluated by, Parents The Problem Areas in Diabetes - Parent Revised (PAID-PR), 18-item self-report measure. It comprises two subscales: Immediate Burden and Theoretical Burden.

  From baseline to post-intervention (14-15 week)

• Children Glycemic Outcomes

  Children´s Glycated Hemoglobin (HbA1c)

  From baseline to post-intervention (14-15 week)

• Children Glycemic Outcomes

  Time in Range (TIR)

  From baseline to post-intervention (14-15 week)

• Children Glycemic Outcomes

  Glucose Management Indicator (GMI)

  From baseline to post-intervention (14-15 week)

• Children Glycemic Outcomes

  Time Bellow Range (TBR)

  From baseline to post-intervention (14-15 week)

• Children Glycemic Outcomes

  Time Above Range (TAR)

  From baseline to post-intervention (14-15 week)

Study Arms (2)

REDCHIP Intervention Group

EXPERIMENTAL

REDCHIP intervention group will receive 10 telehealth group sessions. CBT strategies are utilized to increase parents' awareness of any maladaptive thoughts and behaviors they may have related to FH (e.g., fear associated with in target glucose levels, reducing insulin to maintain higher glucose levels) and help them to adopt more adaptive coping skills. REDCHiP also includes content to improve participant's parenting skills and some T1D education to promote parents' knowledge and skills related to managing their young child's T1D

Behavioral: REDCHiP

Treatment As Usual Control Group

ACTIVE COMPARATOR

These participants will receive the usual treatment provided during their medical appointments

Other: Treatment As Usual Control Group

Interventions

REDCHiP BEHAVIORAL

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.

REDCHIP Intervention Group

Treatment As Usual Control Group OTHER

Participants will receive their treatment as usual in medical appointments

Treatment As Usual Control Group

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Parents with severe psychiatric diagnosis;
• Families of children with another severe chronic condition (e.g., chronic kidney disease and Crohn's disease);
• Parents who are not fluent in Portuguese.

Sponsors & Collaborators

• ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida: lead
• Hospital de Santa Maria, Portugal: collaborator
• Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisboa: collaborator
• Fundação para a Ciência e a Tecnologia: collaborator
• Nemours Children's Clinic: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Vasco V Costa, MD

  William James Center for Research (ISPA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasco V Costa, MD

CONTACT

+351929374601; vcosta@ispa.pt

Vasco Costa

CONTACT

929374601; 26054@alunos.ispa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 1, 2025
• Study Start: April 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share