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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Jill Weissberg-Benchell, Ph.D.
Study ID
NCT06709755
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Supporting Teen Problem Solving — BEHAVIORAL
    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.
  • Diabetes Education — BEHAVIORAL
    Arm Description: The Participants will receive diabetes education directed toward adolescents matching time, group experience and homework assignments, delivered virtually

Study Details

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.

Key Dates

Start date
Jul 10, 2024
Status verified
May 2026
Primary completion
Mar 15, 2029
Completion
Mar 15, 2029

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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

Primary Outcome Measure

Diabetes Distress [ Time Frame: Distress is assessed at baseline, end of intervention (month 4.5), and then 6 (month 10.5) and 12 (month 16.5) months post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann and Robert H Lurie Childrens Hospital of ChicagoChicagoIllinois60611
Jill Weissberg-Benchell, Ph.D.
[email protected]
312-227-3419
Jill Weissberg-Benchell, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Ann and Robert H Lurie Childrens Hospital of Chicago· Chicago, IL

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