Despite recent technological advances in type 1 diabetes (T1D) treatment, adolescents are the only age group for which glycemic levels have not improved. Technology and education help adolescents execute the mechanics of managing blood glucose levels, but do not help adolescents manage the emotional distress that arises when T1D management goals conflict with social/emotional goals (e.g., taking insulin for a meal in front of new friends vs. trying to "fit-in"). The emotional distress caused by such situations can be difficult to manage and can lead to unhealthy risk behaviors and disengagement in T1D self-management (e.g., deciding to skip a lunch-time bolus to avoid bolusing in front of new friends). A novel approach in T1D research is to target emotions directly by promoting emotion regulation skills. In the general population, emotion regulation interventions have demonstrated success in preventing both unhealthy behaviors and mood disorders among younger adolescents, including younger adolescents with social-emotional risk-factors like low SES. The investigators' scientific premise is that an emotion regulation intervention for younger adolescents with T1D (age 12-14) could promote skills to help youth manage emotional burdens of living with T1D, reduce unhealthy and risky T1D self-management behaviors, and prevent unhealthy patterns of behaviors and distress/mood disorders that often appear in later adolescence. Using the ORBIT Model, a systematic framework for developing behavioral interventions for people with chronic diseases, the investigators adapted an evidence-based, manualized emotion regulation intervention for young adolescents, so that it is relevant for youth with T1D. The current study is a natural extension of this previous work. For the current study, the investigators propose to complete a feasibility and acceptability trial of this novel emotion regulation intervention for youth with T1D. The investigators aimed to pilot the novel emotion regulation intervention (11 virtual group sessions) with 3 sequential groups of 6-8 young adolescents (age 12-14) with T1D in each group and obtain feedback from facilitators and participants and their parents after each session, and after the intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
18
The T1D Talks intervention is an 11 session, virtual (online), group intervention. The T1D Talks intervention teaches developmentally appropriate emotion regulation (ER) skills and facilitates practicing these skills via role-plays and in-session experiences that are meant to elicit strong emotions. The investigators adapted the content and situations of an established intervention to be relevant for youth with T1D (e.g., practicing ER skills while role playing situations like telling parents about high blood glucose numbers or telling a coach about needing to take a time out from a game because of a low blood glucose level). The intervention also provides basic diabetes education about risky situations (e.g., how physical activity can affect blood glucose).
Nemours Children's Hospital, Florida
Orlando, Florida, United States
Percent of participants who attended the intervention
Feasibility will be demonstrated by average individual participation in at least 70% of the sessions, and \>70% of participants completing the intervention by participating in the last session.
Time frame: Through study completion, up to 12 weeks
Percent of participants who rated each session as acceptable
The percentage of participants who rated each session as "acceptable" on a post-session survey rating scales that were developed for this study. 6 items on the session evaluation survey assess the following: relevance, trust in the information, ease of understanding, learning novel information, and interest in topics. Item responses include a 5-point Likert scale from "strongly disagree to strongly agree". The research team will average participant's responses across the items, thus total score could be a minimum of 1 and a maximum of 5, with a higher score indicating higher acceptability of the intervention. The intervention will be considered acceptable if ≥ 70% of participants rate each session as acceptable, as indicated by a total score \>3.
Time frame: Through study completion, up to 12 weeks
Percent of participants who rated the overall intervention as acceptable
The percentage of participants who rated the intervention, as a whole, as "acceptable" on a post-intervention survey rating scales that were developed for this study. 16 items on the intervention evaluation survey assess, one's perceptions of the intervention. Item responses include a 5-point Likert scale from "strongly disagree to strongly agree". The research team will reverse score items that negatively worded and average participant's responses across the items, thus total score could be a minimum of 1 and a maximum of 5, with a higher score indicating higher acceptability of the intervention. The intervention will be considered acceptable if ≥ 70% of participants rate the intervention as acceptable, as indicated by a total score \>3.
Time frame: Through study completion, up to 12 weeks
Difficulties in Emotion Regulation- Short Form Scale
The change in the DERS-SF will be measured from baseline to post-intervention (up to 11 weeks). Self-report measure of emotion regulation strategies of particularly negative emotions, rated on a 5 point scale, with higher score indicating greater engagement in strategies.
Time frame: Baseline to post-intervention, up to 11 weeks
Emotion Regulation Behaviors Scale (ERBS-R)
The change in the ERBS-R will be measured from baseline to post-intervention (up to 11 weeks). The ERBS-R measures the use of the specific emotion regulation strategies taught in the ER intervention. Using a scale of 1 ("never") to 5 ("all of the time"), with higher scores indicate more frequent use of the strategies taught.
Time frame: Baseline to post-intervention, up to 11 weeks
Implicit Theories of Emotion Scale- Child Version (ITES-C)
The change in the ITES-C will be measured from baseline to post-intervention (up to 11 weeks). The ITES-C Self subscale assessed adolescents' beliefs about the controllability of their emotions. Six items were rated on a 6-point scale from "strongly disagree" to "strongly agree" and were averaged to create a score. Higher scores indicate stronger beliefs in an incremental theory of emotion (that emotions are malleable) as opposed to an entity theory (that emotions are fixed).
Time frame: Baseline to post-intervention, up to 11 weeks
Affect Dysregulation Scale (ADS)
The change in the ADS will be measured from baseline to post-intervention (up to 11 weeks). The ADS assesses the frequency of adolescents' difficulties with affect regulation, with a higher score indicating greater difficulty.
Time frame: Baseline to post-intervention, up to 11 weeks
Early Adolescent Temperament Questionnaire (EATQ-R select subscales)
The change in the EATQ-R will be measured from baseline to post-intervention (up to 11 weeks), including the following subscales: 5 subscales (29 items): Activation Control , Attention, Frustration , Inhibitory Control, and Surgency. The ADS assesses the frequency of adolescents' difficulties with affect regulation, with a higher score indicating greater difficulty. The current questionnaire has been designed to specifically tap experiences common to adolescents, and is available in self- and parent-report formats. It assesses temperament and self-regulation via adaptation of scales used in studies of children and adults.
Time frame: Baseline to post-intervention, up to 11 weeks
Problem Areas in Diabetes: Teen (PAID-T)
The change in the PAID-T will be measured from baseline to post-intervention (up to 11 weeks). The PAID-T is a 26-item self-report measure of diabetes-specific emotional distress in teens with diabetes, rated on a 6 point scale, with higher scores indicating greater distress.
Time frame: Baseline to post-intervention, up to 11 weeks
Diabetes-related Executive Functioning Scale- short form (DREFS-SF)
The change in the DREFS-SF will be measured from baseline to post-intervention (up to 11 weeks). The DREFS-SF is an 11-item self-report and parent proxy screening measure to assess behaviors related to diabetes- specific executive functioning, with higher scores indicating greater difficulty.
Time frame: Baseline to post-intervention, up to 11 weeks
Diabetes-Specific Risk-Taking Inventory (DSRI)
The change in the DSRI will be measured from baseline to post-intervention (up to 11 weeks). The DSRI is a 31-item (+3 items for insulin pump users) self-report measure assessing risky T1D self-management behaviors, rated on a 6 point scale, with higher score indicating more frequent engagement in risky diabetes-related health behaviors.
Time frame: Baseline to post-intervention, up to 11 weeks
Diabetes Knowledge Questionnaire (DKQ)
The change in the DKQ will be measured from baseline to post-intervention (up to 11 weeks). The DKQ is adapted from other, established diabetes knowledge questionnaires for the purpose of this study. Higher scores indicate more accurate knowledge of information related to diabetes management.
Time frame: Baseline to post-intervention, up to 11 weeks
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