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.
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.
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.
Parallel
REDCHiP
BehavioralREDCHIP 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 interventionParticipants will receive their treatment as usual in medical appointments
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.
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.
Children Glycemic Outcomes
Children´s Glycated Hemoglobin (HbA1c)
Children Glycemic Outcomes
Time in Range (TIR)
Click on the lead sponsor to view all of their trials.
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Lead sponsor
Hospital de Santa Maria, Portugal
Collaborator
Centro Hospitalar de Lisboa Central
Collaborator
Fundação para a Ciência e a Tecnologia
Collaborator
Nemours Children's Clinic
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
