Single Session Intervention for Type 1 Diabetes (ASSISTED Trial)

Orlando, FL

N/A

Waitlist Available

Research Sponsored by Nemours Children's Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child or adolescent age between 11-18 years, inclusive

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 3-months, 6-months

Summary

This trial aims to study whether a one-time depression intervention for young people with type 1 diabetes can help improve their mood and health outcomes. Researchers want to know if this intervention is feasible to implement and

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Who is the study for?

This trial is for young people with Type 1 Diabetes (T1D), including those who may be experiencing low mood or depression. Participants should be willing to attend a single-session intervention, fill out questionnaires, and provide A1c samples over a period of six months.Check my eligibility

What is being tested?

The study tests if a one-time educational session focused on depression can improve the mood and health outcomes of youths with T1D. It compares this approach against regular diabetes education to see which is more effective in reducing depressive symptoms.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medication, there are no direct medical side effects expected. However, discussing mental health could potentially cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 11 and 18 years old.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 3-months, 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 3-months, 6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3-months, 6-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Healthcare Interventions Questionnaire

Feasibility of T1D-specific Depression SSI

Hemoglobin A1c (HbA1c)

+3 more

Secondary study objectives

Diabetes Family Conflict Scale- Revised (DFCS-R)

Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen)

Problem Areas in Diabetes- Teen (PAID-T)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: T1D-specific depression SSIExperimental Treatment1 Intervention

Single session depression intervention adapted for youth with T1D. The T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, where youth will identify key areas (i.e., family relationships, friendships, school, or hobbies) from which they draw (or once drew) enjoyment and meaning, and 3) the creation of an activity action plan, wherein youth identify (from pre-generated lists) and personalize (in guided exercises) three activities to target for change.

Group II: T1D EducationPlacebo Group1 Intervention

Educational material about T1D

0 / 1Eligibility criteria met