Supporting Teen Problem Solving for Diabetes Distress

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

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Must be taking: Insulin

Disqualifiers: Cognitive disorders, Developmental disorders, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The investigators will assess both effectiveness (primary) and implementation (secondary) outcomes for a distress-reducing intervention, Supporting Teen Problem Solving (STePS). STePS has already undergone an efficacy trial. The current study allows for evaluating the outcomes of STePS by delivering it in real-world settings, using real-world providers. The investigators will train these behavioral health providers who are already embedded in diabetes clinics to use the STePS intervention. The investigators will also compare two approaches to intervention delivery: in-person versus telehealth. The investigators have recruited 6 different study sites across the country, representing diversity in rural vs. urban, public vs private insurance, as well as in ethnic and racial background of the participants. 360 teens will be enrolled and randomized to either STePS or an educational control group on a 1:1:1 basis at each of our 6 study sites: STePS in-person (n=120), STePS telehealth (n=120), or educational control via telehealth (n=120). All 3 groups will be delivered as 4.5-month interventions, consisting of 9 sessions offered twice per month. Quantitative data (surveys) will be collected for all participants at baseline, immediately post-intervention, and 6 \& 12 months post-intervention. Qualitative data will also be collected post-intervention through focus groups. 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 meaningful 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). Recruitment, enrollment, representativeness, feasibility, acceptability, appropriateness, fidelity, and costs 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.

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 data supports the effectiveness of the treatment Supporting Teen Problem Solving for Diabetes Distress?

Research shows that the Supporting Teen Problem Solving (STePS) program helps reduce diabetes-specific emotional distress and depressive symptoms in adolescents with type 1 diabetes, with positive outcomes reported up to three years after participation. ^{1 2 3 4 5}

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 Supporting Teen Problem Solving program, but they focus on its impact on emotional distress and depressive symptoms in adolescents with type 1 diabetes. ^{1 2 3 4 6}

How is the Supporting Teen Problem Solving (STePS) treatment different from other treatments for diabetes distress in adolescents?

The STePS treatment is unique because it focuses on enhancing problem-solving skills specifically for adolescents with type 1 diabetes, aiming to prevent distress and depression, rather than just providing diabetes education. ^{1 2 3 5 6}

Research Team

Jill Weissberg-Benchell, Ph.D.

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Diabetes Education (Behavioural Intervention)
• Supporting Teen Problem Solving (Behavioural Intervention)

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.

Participant Groups

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

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Development and validation of the diabetes adolescent problem solving questionnaire. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Development of the diabetes problem-solving measure for adolescents. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Preventing Diabetes Distress in Adolescents With Type 1 Diabetes: Results 1 Year After Participation in the STePS Program. [2019]

4. United States 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Increasing problem solving in adolescents with type 1 diabetes: the choices diabetes program. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A clinic based educational programme for children with diabetes. [2007]