Mental Health Screenings in Adolescents With Type I Diabetes
Condition: Diabetes Mellitus Type I
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

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.
    

Detailed description: 
      Background: More than 200,000 youth in the United States are affected by T1DM, a chronic
      illness that results from an absolute insulin secretion deficiency. Like other chronic
      illnesses, T1DM is a known risk factor for additional health related comorbidities.
      Furthermore, parenting this particular group of adolescents can present its own unique
      challenges and earlier research has established that parenting styles undoubtedly influence a
      child's ability to manage their own care and metabolic control. Although mental health
      disorders are common among adolescents, diabetic youth are reported to be at even higher risk
      for mental health symptoms and adjustment issues. Often, after a diagnosis of T1DM adolescent
      youth may develop anxiety, sadness, and experience social withdrawal. In fact, ∼30% of
      children develop a clinical adjustment disorder within the first 3 months post diagnosis.
      However, these early struggles often resolve within the first year; nevertheless, poor
      adaptation during the initial maladjustment phase has shown to be indicative of later mental
      health symptoms. The risk of suicide or suicide ideation in patients with T1DM is prevalent.
      Previous studies have found that girls with type 1 diabetes appear to be more affected with
      depression, and anxiety than are boys with type 1 diabetes. Additionally, adolescent females
      are at a higher risk of presenting with recurrent diabetic ketoacidosis (DKA) than adolescent
      males. It has also been established that maladaptive child responses to an acute or chronic
      medical condition can result in stress symptoms. Despite T1DM's classification as a treatable
      or manageable illness, failing to adhere to the prescribed treatment regimen can have
      catastrophic results. Severe outcomes can include blindness, DKA, coma, and even death. The
      mere daily threat of experiencing one of these conditions can be enough to evoke a traumatic
      response. Although there is a plethora of studies reporting clinically significant rates of
      post traumatic stress disorder (PTSD) in children who have experienced traumatic injuries,
      transplants, and even cancer, fewer studies have aimed at assessing post-traumatic stress
      responses to T1DM. Self-Efficacy is defined as the belief that one can be successful in
      completing a specific task in a given situation. Adolescent ability to self-manage a chronic
      illness can be negatively impacted by mental health comorbidities. More specifically, these
      mental health comorbidities correlate to poor glycemic control. Previous studies
      investigating Self-Efficacy in adolescents solidified the connection of Self-Efficacy to
      diabetes mellitus and glycemic control. Positive and adequate parental involvement for
      diabetes care is consistently associated with improved metabolic control and adherence.
      Adolescence is marked as a time for increased autonomy, privacy and responsibility, so
      constructing a dynamic balance that includes parental involvement and support to ensure
      proper daily T1DM care seems an ever present challenge. Parenting style may be a more
      specific predictor for diabetes outcomes than other contextual aspects related to the family
      since youth with type 1 diabetes typically depend on their parents' help when managing the
      condition. Three categories of parenting styles have been described, Authoritarian,
      Permissive and Authoritative. Authoritarian parents have high level of assertiveness and
      control in their implementation of structure and clear definitions of rules but express very
      low levels of responsiveness. Alternatively, permissive parents are typically associated with
      addressing childrens' emotional needs yet provide little structure or guidance through
      boundaries. Authoritative parents fall between authoritarian and permissive by maintaining a
      strong but appropriate structure and nurturing amounts of responsiveness and warmth. Research
      has shown parental style to directly affect a child's health outcome, specifically,
      authoritative parenting behaviors are associated with positive health outcomes including
      better glycemic index control, improved adolescent self-care practices, and well-being with
      regards to internalizing and externalizing behaviors. Previous literature has identified
      connections between gender, parenting style, and mental illness. For example, females have
      shown to be more responsive to parenting style as exemplified through increased occurrences
      of depression and poorer adherence when the adolescents view the mother as controlling. The
      relational component exhibited through this trend could indicate a vulnerability, more
      present in girls than boys, considering the interpersonal dynamic between parent and child
      associated with parenting style.

      This study will examine whether or not adolescent girls from New Mexico and West Texas
      diagnosed with T1DM longer than one year are more likely to be affected with mental health
      issues than their male counterparts and to ascertain the impact of these issues on glycemic
      control. Participants will be screened for mental health symptoms using three brief
      instruments currently used in general practice. Additionally, youth reported self-efficacy
      and parenting styles will be assessed. The identified instruments are widely used in
      pediatric clinical and research settings and are appropriate for this age group. Upon
      completion of each screening the appropriate follow up care or referral for services will be
      completed in the interest of patient care. A chart review will be conducted at enrollment to
      obtain demographic information and a history of diabetes management and care, then again at
      12 months after the enrollment.

      Significance: This will be the first study to screen for depression, anxiety, and trauma
      mental health symptoms in youth with T1DM within the west Texas - eastern New Mexico
      geographic region served by Texas Tech University Health Sciences Center (TTUHSC).
      Additionally, self-reported parenting behaviors and parenting styles will be identified.
      Gender and racial differences among the participants will be analyzed with respect to parent
      reported parenting style. The robust Latino population, combined with the rural community
      setting provides a unique perspective regarding measured outcomes. Furthermore, amidst the
      wave of implementation of trauma-informed care services across the United States, the field
      calls for a closer look at the traumatic experiences resulting from type I diabetes
      complications, many of which can be life threatening, and have been found to lead to
      traumatic stress symptomatology. The data collected in this study may serve to inform future
      directions regarding screening protocols and interventions created to address these issues
      and subsequently impact diabetes control and complications among this population.

      Aim: This study aims to assess mental health symptoms and self-efficacy in youth with T1DM
      receiving care in the TTUHSC pediatric endocrine clinic. Furthermore the study seeks to
      analyze the relationships among mental health, parent-reported parenting styles and
      youth-reported self-efficacy regarding self-care and diabetes management. Gender and racial
      differences will be discussed.

      Hypotheses: Adolescent females are more likely to be affected with mental health symptoms
      than their male counterparts. Positive mental health screens will be associated with lower
      self-efficacy regardless of parenting style. Authoritative style parenting will be associated
      with higher self-efficacy, fewer positive mental health screenings, and encounters of
      diabetes complications. Authoritative style parenting will be positively associated with
      diabetes control. Authoritarian style parenting will be associated with lower self-efficacy,
      positive mental health screenings. Authoritarian and permissive style parenting will be
      associated with poor diabetes control, and encounters of diabetes complications. Lastly,
      those who seek mental health services will see improvement with diabetes control (defined by
      hemoglobin A1C levels equal or less than 8.5%) and will be less likely to present to the
      emergency room, require hospital admission due to DKA or other complications of T1DM.

      Study Design and Methods: On May 17th, 2016 the study received IRB approval. Once the trial
      gets registered on ClinicalTrials.Gov, participants will be recruited for enrollment into the
      study.

      Procedures: 1) Study Coordinator will be notified of potential study participants presenting
      to the pediatric endocrine clinic. 2) If the patient meets inclusion criteria for the study,
      the coordinator will ask for consent/assent to participate. 3) Demographic Information will
      be obtained: age at diabetes diagnosis, number of year since diagnosis, gender, zip code,
      race/ethnicity, maternal education, insurance type, length of residence at current home,
      anticipated housing relocation, length of employment at current job, anticipated parental job
      changes, previous mental health screenings and interventions, number of previous DKA episodes
      per year, diabetes control over time by looking at HbA1C measurements during admissions to
      the hospital or during office follow up. 4) Mental Health Screen/Assessment - Study
      participants will be screened for mental health symptoms using the following screening
      instruments: Patient Health Questionnaire for Depression (PHQ - 9), Screen for Child Anxiety
      Related Emotional Disorders (SCARED), University of California Los Angeles (UCLA PTSD)
      Reaction Index - abbreviated version, Youth participants will also complete the Self-Efficacy
      for Diabetes Self-Management scale (SEDM), a parent will complete the self-reported Parenting
      Styles and Dimensions Questionnaire (PSDQ). 5) Follow Up to Assessment: If patient indicates
      thoughts of self-harm or suicide ideation on question 9 of the PHQ-9, then the C-SSRS
      Screener version with triage points risk assessment will be conducted to determine if
      Emergency room follow up is necessary. Actively suicidal patients will be referred to the
      emergency room (ER) for immediate evaluation as per standard of care. Those non suicidal
      patients but with a positive mental health screening(s) will be provided with referral and
      resource information including a list of mental health providers if desired. 6) Initial data
      will be entered and de-identified in the data base, hard copies will be kept in order to
      properly match the participants after the chart review. 7) Twelve months after the initial
      mental health screening a chart review will be conducted to collect the following
      information: Hemoglobin A1C levels in the preceding 12 months ii, number of follow up visits
      with pediatric endocrinology, number of ER visits, number of hospital admissions, number of
      DKA episodes, suicidal Ideation or suicidal Attempts (SA), Non-Suicidal self-injury (NSSI),
      number of visits to mental health providers (If unable to obtain this information through
      their medical chart, then individual mental health providers-from the list provided on
      initial screening - will be contacted to obtain the number of visits during the preceding 12
      months). Data will be entered and de-identified for analysis. At this time any hard copies of
      the assessments will be destroyed.

      Statistical Analysis: All demographic data will be expressed as mean + SD and frequencies
      (%). The differences between males and females will be analyzed using the Student's t-test
      for continuous data and with Chi Square for categorical data during the initial analysis. A
      two-tailed p value of <0.05 will be considered statistically significant. Additional analyses
      will include ANOVA or MANOVA or a regression model during the full analysis. The latest SPSS
      software version will used for statistical analysis
    

Intervention name(s): Mental Health Symptoms; Self-efficacy regarding self-care and diabetes management; Parenting Styles
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Adolescents with T1DM will be asked to complete PHQ9 (depression screening), SCARED (anxiety screening) and UCLA PTSD (trauma screening); Adolescents with T1DM will be asked to complete the SEDM to asses self-efficacy for diabetes management; Parents of adolescents with T1DM will be asked to complete the PSDQ to asses parenting style
Other intervention name(s): PHQ9; SCARED; UCLA PTSD; SEDM; Parenting Styles and Dimensions Questionnaire (PSDQ)
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Diabetes Mellitus Type I; Adolescents; Mental Health; Self efficacy; parenting styles