Adolescent Behavior, Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, Adolescents, Mind-body skills
Brief summary
Adolescence presents a challenging time for type 1 diabetes management, and despite a multitude of studies aimed at increasing disease compliance in this age group, none have been deemed superior. The purpose of this study is to incorporate mindfulness skills in with diabetes education sessions for adolescents with type 1 diabetes and study if this translates to improved outcomes in glycemic control, patient satisfaction, and mental wellness.
Detailed description
This is a pilot study to learn if adding mind-body skills to diabetes education is useful in helping adolescents manage their type 1 diabetes. Specifically, the investigators will be studying adolescents aged 15-17 years old with uncontrolled diabetes defined by an A1c \>9.0% who have also had the diagnosis of diabetes for at least 12 months. This study combines the teaching of mind-body skills with short virtual diabetes education sessions, in order to address both the direct needs of good diabetes management and the indirect needs of coping with diabetes-related stress and other external factors. The investigators will have two arms of the study - one receiving diabetes education with the addition of mind-body skills, and the other arm receiving only diabetes education. Sessions will be conducted virtually with 20-30 minutes of diabetes education, followed by 20-30 minutes of mind-body skills teaching in the respective arm. The study will consist of 10-12 weekly group sessions, with pre- and post-study questionnaires to evaluate mental and physical health. Participants will continue to attend their regular diabetes clinic appointments every three months. At the end of the study, participants will also partake in a short interview to gather feedback about their experience. The goals of this study are to evaluate the effect of mind-body skills as well as pilot test the feasibility and acceptability of such a project.
Interventions
BEHAVIORALMind-body skills
The purpose of mind-body medicine is to use conscious thoughts and actions to positively impact autonomic responses from the brain as well as coping mechanisms for life's stresses. Examples of mind-body skills include deep breathing exercises, meditation, drawing, guided imagery, journaling, affirmations, and biofeedback.
BEHAVIORALDiabetes education
When children and adolescents are diagnosed with diabetes, education is typically focused on the parents; as our older adolescents prepare to transition to adult care with full responsibility of their health, the goal of short education sessions is to review the basics of T1D along with addressing each individual's needs and questions as they make this transition.
Sponsors
Eli Lilly and Company
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The intervention will have two arms - one group will receive diabetes education with the addition of mind-body skills, and the other group will receive only diabetes education.
Eligibility
Sex/Gender
ALL
Age
15 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 15-17 years * Diagnosis of type 1 diabetes for at least 12 months * Uncontrolled diabetes with A1c at least 9.0% * Parent or guardian agrees for adolescent to participate
Exclusion criteria
* Diagnosed cognitive disabilities * Other uncontrolled chronic diseases as assessed by PI * Inability to attend visits due to individual schedules
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of intervention in the study population. | 12 months | Feasibility of recruitment, retention of participants, and intervention completion. This will be measured by considering study participation rate, time to recruit, attendance, study retention rate, study completion rate, participant burden, and data completeness. |
| Acceptability of intervention in the study population. | 12 months | This will be measured by participant satisfaction surveys. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c (HbA1c, %) | 12 months | The change in HbA1c will be measured from baseline to 12 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Peds QL Diabetes Module questionnaire | 12 months | The change in the Peds QL Diabetes Module will be measured from baseline to 12 months. |
| Mindful Attention Awareness Scale (MAAS) questionnaire for adolescents | 12 months | The change in the MAAS will be measured from baseline to 12 months. |
| Patient Health Questionnaire for Adolescents (PHQ-A) | 12 months | Measure of general health and wellbeing. The change in the PHQ-A will be measured from baseline to 12 months. |
| Child and Adolescent Social Support Scale (CASSS) questionnaire | 12 months | The change in the parent and friends subscales of the CASSS will be measured from baseline to 12 months. |
| Difficulties in Emotion Regulation Scale (DERS) questionnaire | 12 months | The change in the DERS will be measured from baseline to 12 months. |
| Screen for Childhood Anxiety Related Emotional Disorders (SCARED-5) questionnaire | 12 months | The change in the SCARED-5 will be measured from baseline to 12 months. |
| Problem Areas in Diabetes - Teens (PAID-T) questionnaire | 12 months | The change in the PAID-T will be measured from baseline to 12 months. |
Countries
United States
Outcome results
None listed