NCT06709755

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

Recruiting now NA Last updated 29 November 2024

What this trial tests

NA trial testing Supporting Teen Problem Solving in Type 1 Diabetes Mellitus in 360 participants. Currently enrolling.

Timeline

10 July 2024

Primary endpoint
15 March 2029

15 March 2029

Quick facts

Lead sponsor	Ann & Robert H Lurie Children's Hospital of Chicago
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	360
Start date	10 July 2024
Primary completion	15 March 2029
Estimated completion	15 March 2029
Sites	1 location across United States

Drugs / interventions tested

• Supporting Teen Problem Solving
• Diabetes Education

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Who can join

Adults 14 to 18, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.