Supporting Teen Problem Solving for Diabetes Distress

Overseen By Jill Weissberg-Benchell Professor, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must be taking: Insulin

Disqualifiers: Cognitive disorders, Developmental disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a program called Supporting Teen Problem Solving (STePS) can help teens with type 1 diabetes manage emotional stress related to their condition. Participants will join one of three groups: STePS delivered in-person, STePS delivered virtually, or a virtual diabetes education group. The researchers aim to determine if STePS can reduce emotional distress and maintain stable blood sugar levels, comparing in-person and virtual methods. Teens who have had type 1 diabetes for at least a year and use daily insulin might be a good fit for this trial, especially if they can access telehealth services. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve emotional well-being for teens with diabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a behavioral intervention, so it's likely you can continue your current diabetes treatment, but please confirm with the trial coordinators.

What prior data suggests that the STePS intervention is safe for teens with diabetes?

Research has shown that the Supporting Teen Problem Solving (STePS) program helps reduce emotional distress and depressive symptoms in teens with type 1 diabetes. For instance, in a previous study, only 23% of the teens reported high distress levels three years after participating in the program, compared to 40% at the beginning. This suggests that the program has lasting positive effects on mental well-being.

However, specific safety information for the STePS program is not available. Detailed data on any negative effects or safety issues directly related to the program is lacking. The trial phase is marked as "Not Applicable," indicating that the program doesn't involve new drugs or medical procedures that typically require strict safety testing.

In summary, while strong evidence supports that STePS can help reduce distress, detailed safety data is not available. Since it's a behavioral program and not a drug or medical device, major safety concerns are unlikely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Supporting Teen Problem Solving (STePS) interventions because they offer a fresh approach to tackling diabetes distress in teens, which isn't addressed by standard diabetes education alone. Unlike typical treatments that focus primarily on diabetes management and education, STePS emphasizes problem-solving skills tailored specifically for adolescents. This intervention is delivered in both virtual and in-person formats, making it highly accessible and adaptable to different needs and preferences. By fostering these skills, researchers hope to empower teens to better handle the emotional and psychological challenges of living with diabetes, potentially improving their overall well-being and health outcomes.

What evidence suggests that the STePS intervention could be effective for reducing diabetes distress in teens?

Research has shown that the Supporting Teen Problem Solving (STePS) program, which participants in this trial may receive, helps reduce stress related to type 1 diabetes in teenagers. Studies found that teens in the STePS program reported feeling less stressed and less depressed. Over three years, the positive effects of STePS remained strong, with participants feeling less stressed than those in other groups. Early results also suggest that the benefits of STePS grow over time, making it a promising way to handle the emotional challenges of diabetes. This evidence supports the idea that STePS can improve the emotional well-being of teens living with diabetes. ^{1 2 3 6 7}

Who Is on the Research Team?

Jill Weissberg-Benchell, Ph.D.

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for teenagers with diabetes who are experiencing emotional distress related to their condition. It's open to a diverse group from different backgrounds and insurance types, across various rural and urban settings. Teens must be able to participate in sessions either in-person or via telehealth.

Inclusion Criteria

I use daily insulin injections.

Fluent in English

Able to provide caregiver consent and teen assent to participate

Exclusion Criteria

Cognitive or developmental disorders

Participants cannot be a ward of the state

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the STePS intervention or educational control over 4.5 months, consisting of 9 sessions offered twice per month

4.5 months

9 sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in diabetes distress and glycemic control at multiple time points post-intervention

12 months

Assessments at 6 and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Education
• Supporting Teen Problem Solving

Trial Overview The trial tests the Supporting Teen Problem Solving (STePS) program against standard diabetes education. STePS aims to reduce distress and prevent worsening glycemic control, delivered over 4.5 months through nine sessions. The study compares in-person vs. telehealth delivery methods.

How Is the Trial Designed?

Group I: STePS in Person. This is the STePS intervention provided in an inperson modality Experimental Treatment 1 Intervention

The participants will receive the 9-session STePS intervention in person

Group II: STePS Virtual. This is the STePS intervention provided in a virtual format Experimental Treatment 1 Intervention

The participants will receive the 9-session STePS intervention virtually

Group III: Diabetes Education Group Active Control 1 Intervention

The Participants will receive diabete education directed toward adolescents matching time, group experience and homework assignments, delivered virtually

Supporting Teen Problem Solving is already approved in United States for the following indications:

Approved in United States as STePS for:

• Reducing diabetes-specific emotional distress in teenagers with Type 1 Diabetes

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Published Research Related to This Trial

The Diabetes Adolescent Problem Solving Questionnaire (DAPSQ) was developed and validated for adolescents with type 1 diabetes, resulting in a reliable 13-item measure that effectively assesses self-management problem-solving skills.

The DAPSQ showed strong internal consistency and was positively correlated with better self-management behaviors and glycemic control, indicating its potential usefulness in guiding patient education and improving diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of the diabetes adolescent problem solving questionnaire. Mulvaney, SA., Jaser, SS., Rothman, RL., et al.[2021]

The Diabetes Problem-Solving Measure for Adolescents (DPSMA) is a newly developed questionnaire that effectively assesses how adolescents with type 1 diabetes manage diabetes-related self-care challenges, based on 17 problem scenarios.

In a study involving 43 adolescents aged 13 to 17, the DPSMA showed strong internal consistency and reliability, indicating it is a valid tool for healthcare providers to evaluate and support the problem-solving skills of their young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the diabetes problem-solving measure for adolescents. Cook, S., Aikens, JE., Berry, CA., et al.[2018]

A study of 49 diabetic children aged 8-14 revealed that they had poor theoretical and practical skills related to diabetes management, regardless of how long they had been diagnosed.

Educational sessions using self-made videos and peer group participation improved knowledge retention and problem-solving skills, suggesting that interactive teaching methods can effectively enhance diabetes education in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinic based educational programme for children with diabetes. Lucey, D., Wing, E.[2007]

A pilot study involving 53 adolescents with type 1 diabetes showed that a 6-week problem-solving education program significantly improved their problem-solving skills and A1C levels, indicating better metabolic control.

Participants in the program also increased their frequency of blood glucose testing compared to the control group, suggesting that the intervention not only enhanced skills but also encouraged more proactive diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing problem solving in adolescents with type 1 diabetes: the choices diabetes program. Cook, S., Herold, K., Edidin, DV., et al.[2022]

The Supporting Teen Problem-Solving (STePS) trial showed that a resilience-promoting intervention (PRP T1D) significantly reduced diabetes-specific emotional distress in adolescents with Type 1 diabetes over a 3-year period, compared to a diabetes education intervention (EI).

Participants in the PRP T1D group also experienced a notable decline in depressive symptoms from 16 to 40 months post-baseline, while those in the EI group did not show similar improvements, highlighting the long-term benefits of resilience-focused interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting Teen Problem-Solving (STEPS) 3 year outcomes: Preventing diabetes-specific emotional distress and depressive symptoms in adolescents with type 1 diabetes. Weissberg-Benchell, J., Shapiro, JB., Bryant, FB., et al.[2021]

The Supporting Teens Problem Solving (STePS) study showed that the Penn Resilience Program for type 1 diabetes (PRP T1D) significantly reduced diabetes distress in adolescents, indicating its effectiveness as a preventive intervention.

One year after the intervention, participants in the PRP T1D group maintained stable glycemic control and showed improvements in resilience and depressive symptoms, suggesting long-term benefits of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Diabetes Distress in Adolescents With Type 1 Diabetes: Results 1 Year After Participation in the STePS Program. Hood, KK., Iturralde, E., Rausch, J., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8279264/

Supporting Teen Problem-Solving (STePS) Three Year ... Results from the three-year outcomes assessment demonstrate the robust effects of PRP T1D in adolescents with declines in distress and depressive symptoms.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33136423/

Supporting Teen Problem-Solving (STEPS) 3 year outcomes Results from the 3-year outcomes assessment demonstrate the robust effects of PRP T1D in adolescents with declines in distress and depressive symptoms.

3. diabetesjournals.org diabetesjournals.org/care/article/41/8/1623/36393/Preventing-Diabetes-Distress-in-Adolescents-With

Preventing Diabetes Distress in Adolescents With Type 1 ... The aim is to report 1-year outcomes of the Supporting Teens Problem Solving (STePS) study, a randomized controlled trial comparing a distress and depression ...

4. breakthrought1d.org breakthrought1d.org/grants/united-states/illinois/a-hybrid-effectiveness-implementation-trial-of-an-intervention-to-reduce-diabetes-specific-emotional-distress/

A hybrid effectiveness implementation trial of an ... 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 ...

5. researchgate.net researchgate.net/publication/345259786_Supporting_Teen_Problem-Solving_STePS_3_Year_Outcomes_Preventing_Diabetes-Specific_Emotional_Distress_and_Depressive_Symptoms_in_Adolescents_With_Type_1_Diabetes

Supporting Teen Problem-Solving (STePS) 3 Year Outcomes PRP T1D participants reported significantly lower diabetes distress compared with EI participants, and the effect size increased over time. For ...

6. withpower.com withpower.com/trial/supporting-teen-problem-solving-for-diabetes-distress-a55f9

Supporting Teen Problem Solving for Diabetes Distress Is the Supporting Teen Problem Solving program safe for adolescents with type 1 diabetes? The research articles do not provide specific safety data for the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0953620524001365

Type 1 diabetes-related distress: Current implications in care Supporting teen problem-solving (STEPS) 3 year outcomes: preventing diabetes-specific emotional distress and depressive symptoms in adolescents with type 1 ...