Mental Health Screenings in Adolescents With Type I Diabetes

NCT02835014 | Completed DMC

• 1 other identifier: L16-118
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type I

Keywords

Diabetes Mellitus Type I; Adolescents; Mental Health; Self efficacy; parenting styles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of patients with a positive anxiety screening

  Available immediately after scoring patient's SCARED questionnaire

• Number of patients with positive PTSD

  Available immediately after scoring patient's UCLA PTSD questionnaire

• Improvement in Diabetes Control defined by HbA1C equal or lower than 8.5%

  One year after screenings were administered and referrals were suggested

Study Arms (1)

Adolescents with T1DM

Adolescents with type I Diabetes Mellitus diagnosed for at least one year will be screened for mental health symptoms with the PHQ9, SCARED and UCLA PTSD. Self-efficacy regarding self-care and diabetes management will be assessed by using the SEDM. Parenting styles will be assessed by administering the Parenting Styles and Dimensions Questionnaire (PSDQ).

Behavioral: Mental Health Symptoms; Behavioral: Self-efficacy regarding self-care and diabetes management; Behavioral: Parenting Styles

Interventions

Mental Health Symptoms BEHAVIORAL

Adolescents with T1DM will be asked to complete PHQ9 (depression screening), SCARED (anxiety screening) and UCLA PTSD (trauma screening)

Also known as: PHQ9, SCARED, UCLA PTSD

Adolescents with T1DM

Self-efficacy regarding self-care and diabetes management BEHAVIORAL

Adolescents with T1DM will be asked to complete the SEDM to asses self-efficacy for diabetes management

Also known as: SEDM

Adolescents with T1DM

Parenting Styles BEHAVIORAL

Parents of adolescents with T1DM will be asked to complete the PSDQ to asses parenting style

Also known as: Parenting Styles and Dimensions Questionnaire (PSDQ)

Adolescents with T1DM

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents from West Texas or Eastern New Mexico ages 12-17 years old diagnosed with type I diabetes for at least one year from the time of enrollment presenting to the pediatric endocrine clinic at Texas Tech University Health Sciences Center for care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (57)

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  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Psychological Well-Being

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Personal Satisfaction; Behavior

Study Officials

• Marcela Nur, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 15, 2016
• Study Start: April 26, 2017
• Primary Completion: January 18, 2018
• Study Completion: November 1, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

US (1)