Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03818711
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2019-01-24
Brief Title:
Communication and Coping for Mothers of Adolescents With Type 1 Diabetes
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Communication and Coping Addressing Mothers Needs to Improve Outcomes in Adolescents With T1D
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T1D
Brief 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
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
Detailed Description:
Mothers of adolescents with type 1 diabetes experience high levels of depressive symptoms which impair their ability to monitor and manage diabetes treatment effectively The regimen recommended for type 1 diabetes is complex and demanding and caregivers - especially mothers - experience stress related to the burden of treatment management This stress is associated with increased risk for psychosocial problems in caregivers with rates of clinically significant depressive symptoms evident in up to 61 of parents 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 Responding to the American Diabetes Associations call to address the psychosocial needs of people with diabetes and their family members the proposed project has the potential to improve outcomes in both adolescents with type 1 diabetes and their mothers
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 We hypothesize that the adolescents of mothers who receive the intervention will demonstrate improvements in diabetes outcomes ie glycemic control adherence as well as psychosocial outcomes ie improved quality of life fewer depressive symptoms compared to those in the attention control condition This approach is innovative by targeting maternal depressive symptoms and the quality of parental involvement in mothers of adolescents with type 1 diabetes
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 We hypothesize that the adolescents of mothers who receive the intervention will demonstrate improvements in diabetes outcomes ie glycemic control adherence as well as psychosocial outcomes ie improved quality of life fewer depressive symptoms compared to those in the attention control condition This approach is innovative by targeting maternal depressive symptoms and the quality of parental involvement in mothers of adolescents with type 1 diabetes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None