Intervention Groups for Adolescents With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to utilize a group therapy adjustment and coping program at the
      Children's Hospital of Wisconsin with patients who have Type 1 Diabetes Mellitus (T1DM) and
      their parents within a "typical" clinical condition of patients who have been referred for
      outpatient therapy services. To extend the previous literature on these types of peer and
      family-based groups to include survey data as well as provider ratings, medical data, and add
      retrospective and prospective data from baseline enrollment. To aid in establishing this
      group therapy methodology as a "promising" evidence-based intervention within a population of
      youths with T1DM and their families. The specific aim of this project is to enroll patients
      and their families into either a treatment group or a wait list control group to receive the
      group intervention to determine the impact of this peer and family-based group on improving
      adjustment, coping, and functioning within diabetes.
    

Detailed description: 
      A total sample size of approximately 40 youth participants and their parents (4 x 6-10) in
      two waves will be recruited. More specifically, there will be a treatment group (n = 6-10)
      and a wait list control group (n = 6-10) who participate in the first wave and another
      treatment group (n = 6-10) and wait list control group (n = 6-10) in the second wave. This
      number was chosen on the basis of including an adequate number of participants to
      appropriately demonstrate the effectiveness of the protocol within a clinical setting, the
      recommendations to conduct group therapy in cohorts of 6-10 to be the most effective
      clinically, and the pragmatics of participant availability based on the referral rates from
      the Diabetes Clinic in the past for mental health treatment. In addition, having 6-10
      participants will allow for some participant attrition without impacting the effectiveness of
      the group therapy.

      All families with an eligible participant, an adolescent between the ages of 13-17 years old
      with T1DM who is seen at the Children's Hospital of Wisconsin Diabetes clinic, will be
      recruited by diabetes providers and study researchers in the Diabetes Clinics and education
      classes, and from referrals to the Child and Adolescent Psychiatry and Behavioral Medicine
      Center Clinic. They will be given a flyer describing the study. Families will contact the
      intake coordinators at the Child and Adolescent Psychiatry and Behavioral Medicine Center to
      receive a phone intake and be screened for appropriateness of their participation in the
      group therapy. An insurance verification will also be completed to determine insurance
      coverage for participating in the group. If a family is not eligible or declines to
      participate in the group therapy research, they will be referred for individual therapy. For
      those participants who do qualify and agree verbally to participate, plans will be made for
      the family to participate in an intake session. At that initial intake visit, if they remain
      interested in participating in this study, they will be randomly assigned to the treatment
      group or the WLC group per the CONSORT Guidelines (Moher et al., 2001). Once they have
      arrived for their intake appointment in the Child and Adolescent Psychiatry and Behavioral
      Medicine Center, the parents and adolescents will be asked to give informed consent/assent
      for both the clinical and research aspects of the group therapy. They will then complete the
      questionnaires before their intake session. In addition, participants will be recruited
      through an advertisement in the Children's Hospital of Wisconsin diabetes
      newsletters/mailings as well as postings of the advertisement flyer and recruitment in the
      Diabetes Clinic.

      Following parental consent and adolescent assent, the parents will complete standardized
      measures of general demographic information, general psychosocial functioning (e.g., quality
      of life, emotional and behavioral functioning of their child, parent stress, health-related
      family impact), and diabetes-related functioning (e.g., adherence, readiness to change
      behaviors, responsibility, health-related quality of life, health satisfaction). The
      adolescents will be asked to complete measures of general demographic information, general
      psychosocial functioning (e.g., quality of life, and emotional and behavioral functioning),
      and diabetes-related functioning (e.g., adherence, readiness to change behaviors,
      responsibility, health-related quality of life). For the treatment group, these measures will
      be given again at post-treatment and then at 4 months after baseline. For the WLC group,
      these measures will be given again at the initiation of group therapy, post-treatment, and 4
      months after starting group treatment. (Please see attached schedule of assessments for
      reference). The length of time to complete these questionnaires is estimated to be around 45
      minutes.

      In addition to the self-report measures, each participant's medical record will be reviewed
      for information for the 6 months prior to baseline and the 6 months after the start of group
      therapy to obtain height, weight Tanner scores, hospital admissions related to diabetes, ER
      visits related to T1DM, outpatient diabetes clinic visits, severity of diabetes ketoacidosis
      (DKA) admissions through pH and HCO3 mEq/L lab work, Hemoglobin A1c levels, categorical
      ratings of diabetes status, and absentee rates at school from the outpatient clinic notes
      during the participation time period. The duration and type of diabetes reported by parents
      will be verified during the medical record review. We will track inpatient and outpatient
      hospital charges for diabetes that occur in the CHW system during the participation time
      frame.

      Participants will be treated as outpatient clinic patients and will be responsible for all
      costs associated with care, including group therapy charges. Funds are not available for
      payment of diabetes self-management education (DSME) fees, clinic fees, lab fees,
      hospitalization or reimbursement of participants. Any medical or mental health costs outside
      of the clinical and research materials (e.g., surveys, copies, and supplies for group
      therapy) during the intervention will be the responsibility of the participant's family or
      third party insurer.
    

Intervention name(s): Group Therapy
Intervention type(s): Behavioral
Intervention description(s): Self-management Group Protocol: The parent sessions will be structured by general topic area, but teaching of clinical and behavioral information will be derived from questions and problems posed by the group in order to actively meet the needs and concerns of participants. The parent sessions will be an interactive process of eliciting concerns and questions, presenting information to address those questions, and following up with a discussion to review concerns and strategies to address the behavioral aspects of the issues. The child sessions will be activity focused, with hands-on opportunities to practice the skills being taught.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus; Adolescents and Families; Group Therapy Intervention