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

NCT06709755 | Recruiting

• 1 other identifier: 2023-6418
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes distress; adolescents

Outcome Measures

Primary Outcomes (2)

• Diabetes Distress

  To assess clinically meaningful changes in DD, the minimal clinically important difference (MCID) represents a threshold value of change in the score that represents a meaningful change in comparison to a statistically significant change. For the PAID measures assessing distress we selected a stringent definition of MCID where the MCID is beyond the 95% confidence interval of the expected random variation in the distress score. For the PAID measures, that would be 8.3. Therefore, if participant's scores on the distress measures are reduced by \>8.3 at the end of 6 months, then we will conclude that STePS has clinically meaningfully reduced distress.

  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

• Time in Range

  TIR is the percentage of time spent in the target glucose range of 70-180 mg/dL. Participants already using a continuous glucose monitor (CGM) will have their data downloaded at each of the 4 assessment time points. We will download data from the past 10 days at each assessment time-point, documenting percent time in range, percent time below 70 mg/dl and percent time above 180 mg/dL. For those not currently using a personal CGM we will give them a Dexcom Gen 6 Pro in a blinded fashion to use at each of the assessment time points. We are using blinded CGM for those without a personal CGM because data suggest that merely using a personal CGM can significantly improve TIR. Since giving participants a personal CGM with access to their data could in and of itself affect TIR, we have chosen to use blinded CGM for those participants so that we can collect the TIR range, but not negatively impact our ability to assess the TIR outcomes from participating in STePS.

  Baseline, end of intervention (month 4.5) and again 6 (month 10.5) and 12 (month 16.5) months post intervention

Study Arms (3)

STePS in Person. This is the STePS intervention provided in an inperson modality

EXPERIMENTAL

The participants will receive the 9-session STePS intervention in person

Behavioral: Supporting Teen Problem Solving

STePS Virtual. This is the STePS intervention provided in a virtual format

EXPERIMENTAL

The participants will receive the 9-session STePS intervention virtually

Behavioral: Supporting Teen Problem Solving

Diabetes Education Group

ACTIVE COMPARATOR

The Participants will receive diabete education directed toward adolescents matching time, group experience and homework assignments, delivered virtually

Behavioral: Diabetes Education

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.

STePS Virtual. This is the STePS intervention provided in a virtual format; STePS in Person. This is the STePS intervention provided in an inperson modality

Diabetes Education BEHAVIORAL

Arm Description: The Participants will receive diabetes education directed toward adolescents matching time, group experience and homework assignments, delivered virtually

Diabetes Education Group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• cognitive or developmental disorders,
• participants cannot be a ward of the state.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• American Diabetes Association: collaborator
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (1)

• Weissberg-Benchell J, Shapiro JB, Bryant FB, Hood KK. Supporting Teen Problem-Solving (STEPS) 3 year outcomes: Preventing diabetes-specific emotional distress and depressive symptoms in adolescents with type 1 diabetes. J Consult Clin Psychol. 2020 Nov;88(11):1019-1031. doi: 10.1037/ccp0000608.

  PMID: 33136423 BACKGROUND

Related Links

• Study Website

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jill Weissberg-Benchell, Ph.D.

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Weissberg-Benchell Professor, Ph.D.

CONTACT

312-227-3419; jwbenchell@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 29, 2024
• Study Start: July 10, 2024
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): March 15, 2029
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)