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NCT06709755 · ClinicalTrials.gov registry record · NA
A Hybrid Effectiveness-implementation Trial to Reduce Diabetes Distress in Teenagers
A NA study of Type 1 Diabetes Mellitus, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 360
- Enrollment target
- 1
- Study location
NCT06709755 is a NA study of Type 1 Diabetes Mellitus that is actively recruiting participants, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 360 participants, above the 137-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (163% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06709755, a NA study of Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 360 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- BEHAVIORAL Diabetes Education
- BEHAVIORAL Supporting Teen Problem Solving
Study Locations (1)
Illinois
- Ann and Robert H Lurie Childrens Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2024-07-10 |
| Est. Completion | 2029-03-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06709755
The ClinicalTrials.gov registry entry for NCT06709755 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 137-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (163% higher). The listed sponsor is Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Diabetes Education is the first listed.
NCT06709755 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT06709755 about?
NCT06709755 is a clinical study titled "A Hybrid Effectiveness-implementation Trial to Reduce Diabetes Distress in Teenagers". 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...
What is the current status of trial NCT06709755?
This trial is currently recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2024-07-10. Estimated completion is 2029-03-15.
What conditions does trial NCT06709755 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT06709755?
The interventions under investigation include: Diabetes Education (BEHAVIORAL), Supporting Teen Problem Solving (BEHAVIORAL).
Who is sponsoring clinical trial NCT06709755?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06709755 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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