Actively Recruiting

Phase Not Applicable
Age: 14Years - 18Years
All Genders
NCT06709755

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

Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2024-11-29

360

Participants Needed

1

Research Sites

244 weeks

Total Duration

On this page

Sponsors

A

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

A

American Diabetes Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
  • Using daily basal and bolus insulin
  • Fluent in English
  • Able to provide caregiver consent and teen assent to participate
  • Able to access telehealth through a digital device
  • Focus on recruiting participants from under-represented populations such as racial and ethnic minorities, low socioeconomic status, public aid recipients, or rural communities
Not Eligible

You will not qualify if you...

  • Presence of cognitive or developmental disorders
  • Participant cannot be a ward of the state

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

J

Jill Weissberg-Benchell Professor, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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