Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03818711 · ClinicalTrials.gov registry record · NA
Communication and Coping for Mothers of Adolescents With Type 1 Diabetes
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 302
- Enrollment target
NCT03818711 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 302 participants.
The verdict
NCT03818711, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 302 participants
- Enrollment target
Study Summary
Mothers of adolescents with type 1 diabetes experience high levels of depressive symptoms, which impair their ability to monitor and manage diabetes treatment effectively. Further, maternal depressive symptoms are one of the strongest predictors of negative outcomes in adolescents, including deteriorating glycemic control, problems with adherence, poorer quality of life, and greater risk for depression. Given that adolescents are a high-risk population for suboptimal glycemic control - with only 17% meeting treatment goals - there is a critical need for novel interventions to improve outcomes in adolescents with T1D. Yet, previous behavioral interventions for youth with diabetes have had only modest effects on glycemic control, and none have directly targeted maternal depressive symptoms. Building on effective interventions to treat depression in adults, and our own pilot work in this population, the proposed study will use a rigorous approach to evaluate the efficacy of a cognitive-behavioral intervention for mothers of adolescents with type 1 diabetes to promote the use of adaptive coping strategies and positive parenting practices. The aims of this study are to: 1) evaluate the effects of the Communication \& Coping intervention on diabetes-related outcomes; 2) evaluate the effects of the Communication \& Coping intervention on psychosocial outcomes; and 3) explore the differential impact of the intervention across demographic factors. Mothers who are randomized to the Communication \& Coping Intervention will receive individual cognitive-behavioral therapy sessions by phone, as well as access to a Facebook group to augment the material covered in calls and provide social support. Mothers randomized to the Attention Control condition will receive educational materials and phone check-ins, as well as a Facebook group with educational posts. Adolescents and their mothers will be assessed at baseline and again post-intervention, at 3 months, 6 months, and 12 months
Interventions
- BEHAVIORAL Communication & Coping Intervention
- BEHAVIORAL Education & Check Ins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2023-09-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03818711
The ClinicalTrials.gov registry entry for NCT03818711 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Communication & Coping Intervention is the first listed.
NCT03818711 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03818711 about?
NCT03818711 is a clinical study titled "Communication and Coping for Mothers of Adolescents With Type 1 Diabetes". Mothers of adolescents with type 1 diabetes experience high levels of depressive symptoms, which impair their ability to monitor and manage diabetes treatment effectively. Further, maternal depressive symptoms are one of the strongest predictors of negative outcomes in adolescents, including deterio...
What is the current status of trial NCT03818711?
This trial is currently completed. It is a NA study. The enrollment target is 302 participants. The study started on 2019-04-01. Estimated completion is 2023-09-02.
What interventions are being tested in trial NCT03818711?
The interventions under investigation include: Communication & Coping Intervention (BEHAVIORAL), Education & Check Ins (BEHAVIORAL).
Who is sponsoring clinical trial NCT03818711?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.