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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Illinois
Ann and Robert H Lurie Childrens Hospital of Chicago
RECRUITING
Chicago
Contact Information
Primary
Jill Weissberg-Benchell Professor, Ph.D.
jwbenchell@luriechildrens.org
312-227-3419
Time Frame
Start Date: 2024-07-10
Estimated Completion Date: 2029-03-15
Participants
Target number of participants: 360
Treatments
Experimental: STePS in Person. This is the STePS intervention provided in an inperson modality
The participants will receive the 9-session STePS intervention in person
Experimental: STePS Virtual. This is the STePS intervention provided in a virtual format
The participants will receive the 9-session STePS intervention virtually
Active_comparator: Diabetes Education Group
The Participants will receive diabete education directed toward adolescents matching time, group experience and homework assignments, delivered virtually
Related Therapeutic Areas
Sponsors
Collaborators: Juvenile Diabetes Research Foundation, American Diabetes Association
Leads: Ann & Robert H Lurie Children's Hospital of Chicago

This content was sourced from clinicaltrials.gov