Diabetes Mellitus Type I Clinical Trial
Official title:
Mental Health Screenings in Adolescents With Type I Diabetes
NCT number | NCT02835014 |
Other study ID # | L16-118 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 26, 2017 |
Est. completion date | November 1, 2020 |
Verified date | December 2020 |
Source | Texas Tech University Health Sciences Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will focus on screening for mental health symptoms in adolescents with type 1 diabetes mellitus (T1DM) while assessing the relationship of these symptoms with a parent-reported parenting styles survey, and the youth's report of their ability to manage their own diabetes care through a self-efficacy survey. Gender differences will be explored in relation to the different measures.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 1, 2020 |
Est. primary completion date | January 18, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility | Inclusion Criteria: - Adolescent patients' from west Texas or eastern New Mexico ages 12-17 years old, who have been diagnosed with Type I diabetes for at least one year from the time of enrollment, who present to the pediatric endocrine clinic for care. Exclusion Criteria: - Patients who are younger than 12 years old or older than 17 years old. Patients who were diagnosed less than one-year ago from time of recruitment will also be excluded. Or, those who decline to participate. |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center |
United States,
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* Note: There are 57 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with a positive depression screening | The PHQ9 questionnaire will be used to identify those patients with depression symptoms, and the total score will allow us to grade the depression into minimal, mild, moderate, moderately severe or severe. At the end of recruitment period we will be able to compare results by gender as well. | Available immediately after scoring patient's PHQ9 questionnaire | |
Secondary | Number of patients with a positive anxiety screening | The SCARED questionnaire will be used to identify those patients with anxiety symptoms for those scoring greater than 25, as well as to identify those with different categories of anxiety such as panic disorder, generalized anxiety disorder, social anxiety, separation anxiety and school avoidance by using the cut off values provided on the screening questionnaire for each category. At the end of recruitment period we will be able to compare results by gender as well | Available immediately after scoring patient's SCARED questionnaire | |
Secondary | Number of patients with positive PTSD | The UCLA PTSD questionnaire will be used to identify those patients with PTSD symptoms as well as the severity based on total score | Available immediately after scoring patient's UCLA PTSD questionnaire | |
Secondary | Improvement in Diabetes Control defined by HbA1C equal or lower than 8.5% | One year after screenings were administered and referrals were suggested |
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