Adaptation of REDCHIP Intervention for the Portuguese Context

Sponsor
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Study ID
NCT07201779
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 8 Years
Healthy Volunteers
Not accepted

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.
  • Treatment As Usual Control Group — OTHER
    Participants will receive their treatment as usual in medical appointments

Study Details

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.

Key Dates

First listed
Oct 1, 2025
Start date
Apr 30, 2026
Status verified
Sep 2025
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: REDCHIP Intervention Group
    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
  • Active Comparator: Treatment As Usual Control Group
    These participants will receive the usual treatment provided during their medical appointments

Primary Outcome Measure

Parents Fear of Hypoglycemia [ Time Frame: From baseline to post-intervention (14-15 week) ]

Central Contacts

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