Type 1 DiabetesREDCHIPNCT07201779
Adaptation of REDCHIP Intervention for the Portuguese Context
A study testing REDCHiP in people with Type 1 Diabetes, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- REDCHiP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) -A Feasibility Randomized Controlled Trial in the Portuguese Context
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.
Read the detailed description
One of the principal fears experienced by parents of young children with T1D is related to the occurrence of hypoglycemia episodes. These events can occur on a daily basis (i.e., often triggered by excessive exercise and/or prolonged periods without food intake) and can lead to severe acute consequences (i.e., seizures and coma) as well as long-term complications (i.e., cognitive decline). Moreover, young children often demonstrate reduced awareness for hypoglycemia and a limited ability to report its symptoms (i.e., sweating, shaking and dizziness) making it challenging for parents and other adult caregivers to detect and treat a hypoglycemic event. Combined these circumstances significantly contribute to heightened parental FH, which in some cases escalate into clinical phobia. In line with the theoretical model of caregiver fear of hypoglycemia, higher parental FH is frequently associated with avoidant behaviors and maladaptive coping strategies related to hypoglycemia. These patterns may contribute to persistently higher glycemic levels and increased variability, which, in turn, can serve as a catalyst for the development of T1D complications in their child. The literature has highlighted the potential impact of parental FH on children's glycemic outcomes and T1D management. It is also unclear whether routine use of an insulin pump or continuous glucose monitor can help to reduce FH in parents of very young children with T1D without the addition of psychological support, suggesting it is a high priority to design and test interventions to effectively treat parental FH, enhance parental well-being, and promote their T1D treatment engagement.
Thus, the original structure of the manualized REDCHiP intervention, is 10 video-based telehealth sessions (i.e.,7 group and 3 individual sessions with duration of 30 to 60 minutes). The present format of the Portuguese REDCHiP will have a 10 video-based telehealth sessions, all in group format, targeting parents of young children (≤ 8 years old) with T1D followed on two major hospitals in Lisbon, Portugal (i.e., Santa Maria Hospital and Dona Estefânia Hospital). This intervention is grounded in Cognitive Behavioral Therapy (CBT) principles, and is designed to address parents FH, and their avoidant coping behaviors related to FH. In addition, the sessions also focus on strengthening parents' coping strategies associated with T1D management and helping them to reduce feelings of diabetes distress Based on previous REDCHiP findings, and with the reported acceptability and feasibility of the intervention study, the investigators hypothesize that participants of intervention group will report lower levels of FH and better glycemic outcomes at immediate post-intervention compared to TAU group. The investigators anticipate group differences in these outcomes at three-month follow up. Furthermore, the investigators expect that REDCHiP will lead to improvements in all psychosocial adjustment factors (i.e., FH, DD, ER, RC, anxiety and depression) among all parents after receiving the REDCHiP intervention.
Accordingly, this protocol outlines the first attempt to culturally adapt and implement the telehealth REDCHiP intervention beyond the United States context.
- Conditions
- Type 1 Diabetes
- Being tested
- REDCHiP, Treatment As Usual Control Group
- Keywords
- REDCHiP, Portuguese Context, Protocol, Psychological Interventions, Parents, Young Children, Type 1 Diabetes, Telehealth
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REDCHiPBehavioural
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 GroupOther
Participants will receive their treatment as usual in medical appointments
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: REDCHiP |
| Treatment As Usual Control Group | Active comparator | These participants will receive the usual treatment provided during their medical appointments Receives: Other: Treatment As Usual Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to post-intervention (14-15 week)
Children Glycemic Outcomes
Children´s Glycated Hemoglobin (HbA1c)
Measured: From baseline to post-intervention (14-15 week)
Children Glycemic Outcomes
Time in Range (TIR)
Measured: From baseline to post-intervention (14-15 week)
Children Glycemic Outcomes
Glucose Management Indicator (GMI)
Measured: From baseline to post-intervention (14-15 week)
Children Glycemic Outcomes
Time Bellow Range (TBR)
Measured: From baseline to post-intervention (14-15 week)
Children Glycemic Outcomes
Time Above Range (TAR)
Measured: From baseline to post-intervention (14-15 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startApr 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Santa Maria, Portugal, Centro Hospitalar de Lisboa Central, Fundação para a Ciência e a Tecnologia, Nemours Children's Clinic
- Responsible party
- Principal investigator, Vasco Vicente Costa, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Investigators
- Vasco V Costa, MD, Principal investigator, William James Center for Research (ISPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201779
- Sponsor's protocol ID
- 114/24 and Inv 631
- Acronym
- REDCHIP
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) -A Feasibility Randomized Controlled Trial in the Portuguese Context
- ClinicalTrials.gov ID
- NCT07201779
- Acronym / sponsor ID
- REDCHIP / 114/24 and Inv 631
- Conditions
- Type 1 Diabetes
- Keywords
- REDCHiP, Portuguese Context, Protocol, Psychological Interventions, Parents, Young Children, Type 1 Diabetes, Telehealth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da VidaUniversity, hospital or other
- Collaborators
- Hospital de Santa Maria, Portugal, Centro Hospitalar de Lisboa Central, Fundação para a Ciência e a Tecnologia, Nemours Children's Clinic
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One of the principal fears experienced by parents of young children with T1D is related to the occurrence of hypoglycemia episodes. These events can occur on a daily basis (i.e., often triggered by excessive exercise and/or prolonged periods without food intake) and can lead to severe acute consequences (i.e., seizures and coma) as well as long-term complications (i.e., cognitive decline). Moreover, young children often demonstrate reduced awareness for hypoglycemia and a limited ability to report its symptoms (i.e., sweating, shaking and dizziness) making it challenging for parents and other adult caregivers to detect and treat a hypoglycemic event. Combined these circumstances significantly contribute to heightened parental FH, which in some cases escalate into clinical phobia. In line with the theoretical model of caregiver fear of hypoglycemia, higher parental FH is frequently associated with avoidant behaviors and maladaptive coping strategies related to hypoglycemia. These patterns may contribute to persistently higher glycemic levels and increased variability, which, in turn, can serve as a catalyst for the development of T1D complications in their child. The literature has highlighted the potential impact of parental FH on children's glycemic outcomes and T1D management. It is also unclear whether routine use of an insulin pump or continuous glucose monitor can help to reduce FH in parents of very young children with T1D without the addition of psychological support, suggesting it is a high priority to design and test interventions to effectively treat parental FH, enhance parental well-being, and promote their T1D treatment engagement.
Thus, the original structure of the manualized REDCHiP intervention, is 10 video-based telehealth sessions (i.e.,7 group and 3 individual sessions with duration of 30 to 60 minutes). The present format of the Portuguese REDCHiP will have a 10 video-based telehealth sessions, all in group format, targeting parents of young children (≤ 8 years old) with T1D followed on two major hospitals in Lisbon, Portugal (i.e., Santa Maria Hospital and Dona Estefânia Hospital). This intervention is grounded in Cognitive Behavioral Therapy (CBT) principles, and is designed to address parents FH, and their avoidant coping behaviors related to FH. In addition, the sessions also focus on strengthening parents' coping strategies associated with T1D management and helping them to reduce feelings of diabetes distress Based on previous REDCHiP findings, and with the reported acceptability and feasibility of the intervention study, the investigators hypothesize that participants of intervention group will report lower levels of FH and better glycemic outcomes at immediate post-intervention compared to TAU group. The investigators anticipate group differences in these outcomes at three-month follow up. Furthermore, the investigators expect that REDCHiP will lead to improvements in all psychosocial adjustment factors (i.e., FH, DD, ER, RC, anxiety and depression) among all parents after receiving the REDCHiP intervention.
Accordingly, this protocol outlines the first attempt to culturally adapt and implement the telehealth REDCHiP intervention beyond the United States context.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REDCHIP Intervention Group | Experimental | Behavioral: REDCHiPREDCHIP 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 |
| Treatment As Usual Control Group | Active comparator | Other: Treatment As Usual Control GroupThese participants will receive the usual treatment provided during their medical appointments |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REDCHiPREDCHIP 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. | Behavioural | REDCHIP Intervention Group |
| Treatment As Usual Control GroupParticipants will receive their treatment as usual in medical appointments | Other | Treatment As Usual Control Group |
Primary outcome
Parents Fear of Hypoglycemia
Time frame: From baseline to post-intervention (14-15 week)
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
Time frame: From baseline to post-intervention (14-15 week)
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
Time frame: From baseline to post-intervention (14-15 week)
Children´s Glycated Hemoglobin (HbA1c)
Children Glycemic Outcomes
Time frame: From baseline to post-intervention (14-15 week)
Time in Range (TIR)
Children Glycemic Outcomes
Time frame: From baseline to post-intervention (14-15 week)
Glucose Management Indicator (GMI)
Children Glycemic Outcomes
Time frame: From baseline to post-intervention (14-15 week)
Time Bellow Range (TBR)
Children Glycemic Outcomes
Time frame: From baseline to post-intervention (14-15 week)
Time Above Range (TAR)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vasco V Costa, MD principal investigator
William James Center for Research (ISPA)
Questions about this trial
What is this clinical trial studying?
A study testing REDCHiP in people with Type 1 Diabetes, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vasco V Costa, MD (+351929374601, vcosta@ispa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents Fear of Hypoglycemia (time frame: From baseline to post-intervention (14-15 week)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.