Clinical trial NCT02835014: Mental Health Screenings in Adolescents With Type I Diabetes
Official title: Mental Health Screenings in Adolescents With Type I Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type I
Keywords: Diabetes Mellitus Type I
Adolescents
Mental Health
Self efficacy
parenting styles
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
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.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with a positive depression screening
timeFrame: Available immediately after scoring patient's PHQ9 questionnaire
Secondary outcomes:
measure: Number of patients with a positive anxiety screening
timeFrame: Available immediately after scoring patient's SCARED questionnaire
measure: Number of patients with positive PTSD
timeFrame: Available immediately after scoring patient's UCLA PTSD questionnaire
measure: Improvement in Diabetes Control defined by HbA1C equal or lower than 8.5%
timeFrame: One year after screenings were administered and referrals were suggested
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Marcela Nur, MD
role: PRINCIPAL_INVESTIGATOR
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