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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: Completed NA study, sponsored by Vanderbilt University Medical Center.
NCT03818711 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 302 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin.
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 |
What the finished NCT03818711 record still lists
NCT03818711 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Communication & Coping Intervention is the first listed.
NCT03818711 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03818711's enrollment target sits among peer trials
302 330th of 2000 higher than 1,671 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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