Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 17
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Nemours Children's Health System · Other
Who this trial is looking for
This trial is looking for young people aged 11-18 with type 1 diabetes who may be feeling depressed. Participants will take part in a one-time session aimed at improving mood and will complete questionnaires at the beginning and after three and six months.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 11 and 18 years old.
I have type 1 diabetes confirmed by a doctor for at least 6 months.
I had a positive score for depression in the last year.
I am not currently receiving mental healthcare.
I can speak and understand English.
You may not be able to join if
I have another serious ongoing medical illness.
I have had thoughts of suicide in the past year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this clinical trial is to learn if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is feasible and acceptable to patients. can help improve mood and health outcomes. It will also learn about the initial efficacy of the intervention. The main questions it aims to answer are:
1. Is a single-session depression intervention for youth with T1D fea…
The goal of this clinical trial is to learn if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is feasible and acceptable to patients. can help improve mood and health outcomes. It will also learn about the initial efficacy of the intervention. The main questions it aims to answer are:
1. Is a single-session depression intervention for youth with T1D feasible to recruit and implement?
2. Is a single-session depression intervention for youth with T1D acceptable to patients (i.e., do they find it helpful)?
3. Does a single-session depression intervention for youth with T1D lead to improvements in low mood?
Researchers will compare a single-session depression intervention for youth with to a education control to see if a single-session depression intervention works to improve depressive symptoms.
Participants will:
* Participate in a single-session depression intervention
* Complete questionnaires and provide a sample for A1c at a baseline, 3-month, and 6-month visit
* Complete daily questionnaires once a day for two weeks before and after the single-session depression intervention
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Child or adolescent age between 11-18 years, inclusive
* Physician confirmed T1D diagnosis of at least 6 months duration prior to study enrollment
* Positive depression screening score of \>5 on the PHQ-9 in the last year
* Not currently engaged in outpatient mental healthcare…
Inclusion Criteria:
* Child or adolescent age between 11-18 years, inclusive
* Physician confirmed T1D diagnosis of at least 6 months duration prior to study enrollment
* Positive depression screening score of \>5 on the PHQ-9 in the last year
* Not currently engaged in outpatient mental healthcare
* English fluency
Exclusion Criteria:
* Another systemic chronic medical illness except for celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma
* Any score of 1, 2, or 3 on item 9 (indicating suicidal ideation) of the PHQ-9 in the last year.
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