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Mindful Self-Compassion Program for Type 1 Diabetes (TADS Trial)
N/A
Waitlist Available
Led By Marie-Eve Robinson, MD, MSc
Research Sponsored by Children's Hospital of Eastern Ontario
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with type 1 diabetes at least 6 months prior to enrollment
Between 12-17 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks, 3 months, 6 months, 12 months
Awards & highlights
TADS Trial Summary
This trialstudies if virtual mindful self-compassion can reduce emotional distress for young people with type 1 diabetes.
Who is the study for?
This trial is for adolescents aged 12-17 with type 1 diabetes diagnosed at least 6 months ago. They must be able to consent and speak English or French fluently. It's not suitable for those with serious mental illnesses, intellectual disabilities, involvement in other mental health trials, or acute suicidality.Check my eligibility
What is being tested?
The study tests if a virtual Mindful Self-Compassion Program can reduce emotional distress in youths with type 1 diabetes compared to the usual care they receive without this program.See study design
What are the potential side effects?
Since the intervention involves a psychological educational program rather than medication, no traditional side effects are expected; however, participants may experience varying emotional responses during the process.
TADS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with type 1 diabetes over 6 months ago.
Select...
I am between 12 and 17 years old.
TADS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 8 weeks, 3 months, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks, 3 months, 6 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diabetes Distress as measured by the Problem Areas in Diabetes - Teen Version (PAID-T)
Secondary outcome measures
Anxiety as measured by the Generalized Anxiety 7-item scale (GAD-7)
Mental Depression
Diabetes distress as measured by the Problem Areas in Diabetes - Teen version (PAID-T)
+2 moreOther outcome measures
Glycosylated hemoglobin A
Interaction term of time and diabetes distress
Time in Range
TADS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindful Self-Compassion ArmExperimental Treatment1 Intervention
Participants in this arm will participate in an 8-week virtual mindful self-compassion program.
Group II: Wait-list Control ArmActive Control1 Intervention
Participants in this arm will receive usual clinical care and will have the opportunity to participate in the mindful self-compassion program at the end of the study.
Find a Location
Who is running the clinical trial?
Children's Hospital of Eastern OntarioLead Sponsor
126 Previous Clinical Trials
55,341 Total Patients Enrolled
Brain CanadaOTHER
18 Previous Clinical Trials
5,859 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,643 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not fluent in English or French to complete study tasks.I have never been diagnosed with a serious mental illness like schizophrenia or bipolar disorder.I was diagnosed with type 1 diabetes over 6 months ago.If you are feeling like you want to harm yourself, you won't be able to join the study.You are currently involved in another study related to mental health treatment.You have a disability that would make it difficult for you to take part in the treatment, as determined by your doctor.I am between 12 and 17 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Mindful Self-Compassion Arm
- Group 2: Wait-list Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to volunteer for this trial?
"This medical investigation needs 122 participants aged between 12 and 17, diagnosed with type 1 diabetes for at least 6 months prior to enrollment, who are capable of consenting."
Answered by AI
Are new participants still being accepted into this experiment?
"Affirmative. Clinicaltrials.gov details that this clinical investigation is currently enrolling participants and was originally posted on October 4th 2022 with the most recent update occurring a week later, on the 11th of October 2022. 122 volunteers are required for assessment at one single medical centre."
Answered by AI
How many individuals are being monitored for this research endeavor?
"Affirmative. The details posted on clinicaltrials.gov attest to the fact that this research is still recruiting participants. This scientific investigation, which was initially launched on October 4th 2022, requires 122 patients across a single location."
Answered by AI
Does this experiment require participants who are of legal age?
"This clinical trial is seeking participants aged between 12 and 17 years."
Answered by AI
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