RecruitingNot ApplicableNCT06709755

A Hybrid Effectiveness-implementation Trial to Reduce Diabetes Distress in Teenagers

A Hybrid Effectiveness-implementation Trial of an Intervention to Reduce Diabetes-specific Emotional Distress in Teenagers


Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Enrollment

360 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 14 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a program to help teenagers with Type 1 diabetes manage the emotional stress that often comes with living with the condition, delivered via telehealth. **You may be eligible if...** - You are a teenager diagnosed with Type 1 diabetes for at least 1 year - You use daily insulin injections (basal/bolus regimen) - You speak and understand English - You have a caregiver willing to participate - You have access to a phone, tablet, or computer for video visits - You are from a minority, low-income, rural, or underrepresented community (the study especially encourages enrollment from these groups) **You may NOT be eligible if...** - You have a cognitive or developmental disorder - You are a ward of the state Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSupporting Teen Problem Solving

STePS is a group-based, teen-focused intervention aimed at reducing diabetes-specific emotional distress and building diabetes resilience. STePS is grounded in both cognitive-behavioral and social problem-solving theories, which recognize the interrelationships among difficult situations, beliefs related to the cause and consequences of those situations, and the emotional and behavioral consequences of those beliefs, and which addresses problem solving strategies that influences ones' adaptive functioning in real-life social settings, distinguishing between problem solving and solution implementation. STePS reduces distress by teaching: 1) emotion regulation, helping teens learn to link beliefs, emotions, and behaviors; to challenge negative thinking by evaluating the accuracy of one's beliefs; and learning new coping skills.2) perspective taking, helping teens learn to identify their own thinking style.

BEHAVIORALDiabetes Education

Arm Description: The Participants will receive diabetes education directed toward adolescents matching time, group experience and homework assignments, delivered virtually


Locations(1)

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

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NCT06709755


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