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

Inclusion Criteria5

  • T1D diagnosis for at least 1-year,
  • using daily basal/bolus insulin,
  • fluent in English,
  • able to provide caregiver consent and teen assent to participate
  • able to access telehealth via a digital device. We will focus recruitment on participants from populations under-represented in diabetes research (e.g., racial and ethnic minorities, families of low SES, using public aid, or living in rural communities).

Exclusion Criteria2

  • cognitive or developmental disorders,
  • participants cannot be a ward of the state.

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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