Objective
Diabetes distress among teens is common and associated with poor glycemic control and poor psychosocial outcomes. Diabetes-specific emotional distress arises from living with diabetes and the burden of relentless daily self-management. Diabetes distress is common in teenagers and is strongly associated with worse glycemic control. If left untreated, diabetes distress does not resolve over time. In fact, teens are a particularly vulnerable population, as only 17% achieve recommended glycemic targets for time-in-range (TIR) of 70-180 mg/dL and hemoglobin A1c <7.0%, increasing their risk for future complications.
Very few interventions are aimed at reducing distress in teens. Our team conducted the only effective trial of a group-based, teen-focused intervention, Supporting Teen Problem Solving (STePS). STePS reduces diabetes-specific emotional distress and builds diabetes resilience, showing clinically meaningful (and statistically significant) results in a highly controlled study funded by the NIH. Our publications document that diabetes distress was reduced up to three years after STePS ended. One important advantage of STePS is that the resilience-building skills taught can be applied to both generic adolescent stressors (e.g. school, peers, parents) and diabetes-specific stressors. The powerful STePS content, combined with the broad inclusion criterion (teens do not need to have elevated diabetes distress to participate), and the social support that comes with the group-based format of STePS, provides an avenue for many long-lasting positive outcomes related to diabetes distress and beyond.
We propose testing the effectiveness of STePS in standard clinical practice while simultaneously gathering implementation data to guide future implementation efforts. The efficacy of STePS compels us to assess the effectiveness and generalizability of the findings from the RCT efficacy trial to the larger population of teens with T1D living in the United States. Currently, we have begun conducting a type 1 hybrid effectiveness-implementation trial, funded by the ADA to test STePS in 6 geographically distinct pediatric diabetes centers. We are leveraging behavioral health providers who are already embedded in diabetes clinics to provide the STePS intervention, and we are comparing two distinct program delivery methods: in-person and telehealth. The current application seeks to capitalize on our ongoing hybrid effectiveness-implementation trial by expanding the sample size to fully-power this trial to determine effectiveness in real-world diabetes settings AND to enhance the implementation outcomes aims to be able to fully scale the intervention.
In direct response to JDRF’s RFA: Effectiveness and Implementation Trials to Address Mental Health in Type 1 Diabetes, the specific aims are:
Aim 1. To test, in 360 teens across 6 clinical sites, the effectiveness of STePS in improving diabetes- specific emotional distress and preventing worsening glycemic control, both immediately post intervention and over time. Hypothesis 1a: STePS will lead to clinically and statistically significant improvements in diabetes distress. Hypothesis 1b: STePS will prevent the worsening of glycemic control (A1C and Time in Range). These hypotheses are consistent with the efficacy trial and will prove effectiveness when implemented in real- world settings.
Aim 2. To assess the implementation of STePS among key stakeholders (teen participants, interventionists, diabetes clinicians). Recruitment, enrollment, representativeness, adoption, feasibility, acceptability, appropriateness, fidelity, costs and maintenance will be assessed as well as preferred implementation approaches. Hypothesis 2a. Stakeholders will find few perceived barriers to implementing STePS and many perceived facilitators for adopting it in their clinical settings. Hypothesis 2b. Implementation strategies will be plausible in diabetes clinics across the country.
Aim 3. To explore barriers and facilitators to STePS implementation across a broader range of pediatric diabetes clinics, to determine if any future adaptations will be needed to successfully implement STePs at a national scale.
Background Rationale
Diabetes distress among teens is common and associated with poor glycemic control and poor psychosocial outcomes. Diabetes-specific emotional distress (abbreviated DD) results from living with diabetes and the burden of relentless daily self-management. Teens are at high risk for DD as diabetes self-management behaviors decline, and glycemic control worsens. DD is highly prevalent in teenagers (21%–52%) and almost 50% of teens rate diabetes as the top stressor in their lives. DD is associated with suboptimal glycemic control, and an increased risk of future complications, even when controlling for demographic variables such as race and socioeconomic status. DD is a stronger predictor of A1c than depression, and maladaptive coping strategies. In a study of DD trajectories, teens with higher A1cs at baseline were more likely to experience chronically high levels of DD over time. Teens are a particularly vulnerable population, as only 17% achieve recommended glycemic targets for time-in-range (TIR) of 70-180 mg/dL and hemoglobin A1c <7.0%, increasing their risk for future complications.
Few psychosocial interventions focus on reducing diabetes distress in teens. To our knowledge, there are only 4 research teams who address diabetes distress in the pediatric population. One team focuses on school-aged children and their parents, and 3 focus on teens. Two of those teams focus on teens who are already experiencing elevated distress levels, and while the protocols for these interventions have been published, the outcomes have not. The third team focused on preventing adolescent diabetes distress, but like the other two, the intervention protocol has been published, but the outcomes have not.
Our team conducted the only effective trial of a highly scalable teen-group intervention, Supporting Teen Problem Solving (STePS). STePS is a group-based, teen-focused intervention aimed at reducing diabetes-specific emotional distress and building diabetes resilience. STePS has shown efficacy in a study funded by the NIH. Notably, while 40% of teens in this efficacy trial experienced elevated DD at baseline, nearly half of those teens no longer experienced elevated DD 3 years later, a statistically significant and clinically meaningful outcome. STePS also prevented worsening A1c over time, with 3-year post-intervention results of stable A1c. This outcome is noteworthy because longitudinal studies show worsening A1c throughout the teen years. Improving glycemic control in teens is challenging and STePS offers an important step forward to moving the needle on this seemingly intractable outcome. Unlike the interventions described above, STePS can be applied to both generic adolescent stressors (e.g. school, peers, parents) and diabetes-specific stressors. Moreover, the broad inclusion criterion (teens do not need to have elevated diabetes distress to participate), and the social support that comes with the group-based format of STePS, provides an avenue for many long-lasting positive outcomes related to diabetes distress and beyond.
Given the urgent need to translate research-based interventions into real-world settings, and the unacceptable lag-time between efficacy trials and routine uptake of clinical interventions, we propose testing the effectiveness of STePS in standard clinical practice while simultaneously gathering implementation data to guide future implementation efforts. Currently, we have begun conducting a type 1 hybrid effectiveness-implementation trial, funded by the ADA to test STePS in 6 geographically distinct pediatric diabetes centers. Specific innovations for the ADA-funded trial include 1) leveraging behavioral health providers who are already embedded in diabetes clinics to provide the STePS intervention, and 2) contrasting two distinct program delivery methods: in-person and telehealth. The current application seeks to capitalize on our ongoing hybrid effectiveness-implementation trial by expanding the sample size to fully-power this trial to determine effectiveness in real-world diabetes settings AND to enhance the implementation outcomes aims to be able to fully scale the intervention.
Description of Project
Diabetes distress among teens is common and associated with poor glycemic control and poor psychosocial outcomes. Diabetes-specific emotional distress arises from living with diabetes and the burden of relentless daily self-management. Diabetes distress is common in teenagers and is strongly associated with worse glycemic control. If left untreated, diabetes distress does not resolve over time. In fact, teens are a particularly vulnerable population, as only 17% achieve recommended glycemic targets for time-in-range (TIR) of 70-180 mg/dL and hemoglobin A1c <7.0%, increasing their risk for future complications.
Alarmingly, despite the vital importance of addressing diabetes distress, very few interventions are aimed at reducing distress in teens. Our team conducted the only effective trial of a highly scalable teen-group intervention, Supporting Teen Problem Solving (STePS). STePS is a group-based, teen-focused intervention aimed at reducing diabetes-specific emotional distress and building diabetes resilience. STePS has shown both clinically meaningful (and statistically significant) results in a highly controlled study funded by the NIH. Our published findings show that diabetes distress was reduced up to three years after the intervention ended. One important advantage of STePS is that the resilience-building skills taught can be applied to both generic adolescent stressors (e.g. school, peers, parents) and diabetes-specific stressors. This NIH-funded STePS efficacy trial was completed under ideal study conditions, including restricted inclusion criteria and highly trained interventionists. Given the urgent need to translate research-based interventions into real-world settings, and the unacceptable lag-time between these types of research trials and getting these interventions into the hands of the families that need it, we propose completing a type 1 hybrid effectiveness-implementation trial, testing the effectiveness of STePS in standard clinical practice while simultaneously gathering implementation data to guide future strategies for disseminating this intervention into diabetes program across the country.
This proposal is innovative because: 1) STePS will be implemented by the behavioral health providers who are already integrated into the diabetes clinic setting and who would naturally implement STePS in a real world setting. The benefits of leveraging existing resources helps to demonstrate the real world application of this intervention as it helps programs recognize the feasibility of integrating STePS into their diabetes program without needing to secure additional funding for new providers. 2) We will compare two different methods of offering the intervention: in-person or via telehealth. This increases the likelihood of disseminating STePS, reducing barriers to access to psychosocial programs, and increasing equitable access to care while retaining scalability.
We propose the following specific aims in direct response to JDRF’s RFA: Effectiveness and Implementation Trials to Address Mental Health in Type 1 Diabetes:
Aim 1. To test, in 360 teens across 6 clinical sites, the effectiveness of STePS in improving diabetes- specific emotional distress and preventing worsening glycemic control, both immediately post intervention and over time. We expect that STePS will lead to significant improvements in diabetes distress. We also expect that STePS will prevent the worsening of glycemic control (A1C and Time in Range).
Aim 2. To assess the implementation of STePS among key stakeholders (teen participants, interventionists, diabetes clinicians). We will assess our successes and challenges related to recruiting and enrolling participants. We will assess stakeholder’s experiences related to the feasibility and acceptability of STePS. We will assess the costs related to STePS. We will compare stakeholders’ preferences related to the in-person versus telehealth methods of delivery.
Aim 3. To explore barriers and facilitators to STePS implementation across a broader range of pediatric diabetes clinics, to determine if any future adaptations will be needed to successfully implement STePs at a national scale.
Anticipated Outcome
The goal of this study is to determine if a diabetes-distress reducing intervention for teenagers with type 1 diabetes can be integrated into diabetes clinics and run by behavioral health specialists already embedded in those clinics. We aim to achieve this goal by delivering and assessing: Supporting Teen Problem Solving (STePS), a group-based, teen-focused intervention aimed at reducing diabetes-specific emotional distress and building diabetes resilience. We will test two goals: 1) to assess the effectiveness of STePS by determining if it can be integrated into diabetes clinics and run by behavioral health specialists already embedded in those clinics, and 2) simultaneously gather implementation data to guide future strategies for disseminating this intervention into diabetes program across the country. The findings from this study have strong public health significance, which strengthened by the focus on improving outcomes via a scalable, distress-reducing, resilience-building intervention. We expect to find that STePS improves diabetes-specific emotional distress in the vulnerable population of teenagers with T1D while also preventing the typical worsening of glycemic control during the teenage years. We also expect to find that STePS is easily implemented in diabetes clinics across the country, and that teen participants, interventionists and diabetes health-care professionals all find value in the program. Specifically, at the end of the study we will be able to assess the reach, adoption, implementation and maintenance of STePS, as well as the potential facilitators and barriers to STePS implementation more broadly. Further, by comparing implementation outcomes between the two intervention delivery modalities (in-person versus telehealth) we will be able to determine if a telehealth delivery model can extend the reach and access to this program, thereby reducing barriers to participating in empirically supported treatment programs. Ultimately, we hope to disseminate an acceptable, feasible and sustainable intervention that improves both psychosocial and metabolic outcomes for teenagers with Type 1 diabetes.
Relevance to T1D
Diabetes distress among teens is common and associated with poor glycemic control and poor psychosocial outcomes. Diabetes-specific emotional distress (abbreviated DD) results from living with diabetes and the burden of relentless daily self-management. Teens are at high risk for DD as diabetes self-management behaviors decline, and glycemic control worsens. DD is highly prevalent in teenagers (21%–52%) and almost 50% of teens rate diabetes as the top stressor in their lives. DD is associated with suboptimal glycemic control, and an increased risk of future complications, even when controlling for demographic variables such as race and socioeconomic status. DD is a stronger predictor of A1c than depression. In a study of DD trajectories, teens with higher A1cs at baseline were more likely to experience chronically high levels of DD over time. Teens are a particularly vulnerable population, as only 17% achieve recommended glycemic targets for time-in-range (TIR) of 70-180 mg/dL and hemoglobin A1c <7.0%, increasing their risk for future complications. The American Diabetes Association’s (ADA) and the International Association for Pediatric and Adolescent Diabetes (ISPAD) standards of care highlight the need to address DD, and NIDDK has recognized DD as a vital intervention target.
Few psychosocial interventions focus on reducing diabetes distress in teens. Our team conducted the only efficacious trial of a highly scalable teen-group intervention, Supporting Teen Problem Solving (STePS). STePS is a group-based, teen-focused intervention aimed at reducing diabetes-specific emotional distress and building diabetes resilience. In a randomized controlled trial, while 40% of teens participating in STePS experienced elevated DD at baseline, nearly half of those teens no longer experienced elevated DD 3 years later, a statistically significant and clinically meaningful outcome. STePS also prevented worsening A1c over time, with 3-year post-intervention results of stable A1c. This outcome is noteworthy because longitudinal studies show worsening A1c throughout the teen years, with improvements in A1c not typically seen until youth are older than 25 years of age. Less than 15% of teens have stable A1c over time. Improving glycemic control in teens is challenging and STePS offers an important step forward to moving the needle on this seemingly intractable outcome.
The original STePS study was completed under ideal research conditions. Given the urgent need to translate research-based interventions into real-world settings, we propose to concurrently test the effectiveness of STePS in real-world pediatric diabetes clinics while simultaneously gathering implementation data to be able to fully scale the intervention. Specific innovations for this proposal include: 1) leveraging behavioral health providers who are already embedded in diabetes clinics to provide the STePS intervention, and 2) contrasting two distinct program delivery methods: in-person and telehealth. The public health significance of this study is strengthened by the focus on improving outcomes via a scalable, distress-reducing, resilience-building intervention.
We expect to find that STePS improves diabetes-specific emotional distress in the vulnerable population of teenagers with T1D while also preventing the typical worsening of glycemic control during the teenage years. We also expect to find that STePS is easily implemented in diabetes clinics across the country, and that teen participants, interventionists and diabetes health-care professionals all find value in the program. Specifically, we will be able to assess potential facilitators and barriers to STePS implementation. Moreover, by comparing the two intervention delivery modalities (in-person versus telehealth) we will be able to determine if a telehealth delivery model can extend the reach and access to this program, thereby reducing barriers to participating in empirically supported treatment programs. Ultimately, we hope to disseminate an acceptable, feasible and sustainable intervention that improves both psychosocial and metabolic outcomes for teenagers with Type 1 diabetes.