Studies
| Study First Submitted Date | 2019-01-24 |
| Study First Posted Date | 2019-01-28 |
| Last Update Posted Date | 2022-09-07 |
| Start Month Year | April 1, 2019 |
| Primary Completion Month Year | June 30, 2023 |
| Verification Month Year | September 2022 |
| Verification Date | 2022-09-30 |
| Last Update Posted Date | 2022-09-07 |
Detailed Descriptions
| Sequence: | 20841238 |
| 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 Association's 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 (i.e., glycemic control, adherence), as well as psychosocial outcomes (i.e., 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. |
Facilities
| Sequence: | 201197453 |
| Name | Vanderbilt University Medical Center |
| City | Nashville |
| State | Tennessee |
| Zip | 37232 |
| Country | United States |
Conditions
| Sequence: | 52477623 |
| Name | Type 1 Diabetes Mellitus |
| Downcase Name | type 1 diabetes mellitus |
Id Information
| Sequence: | 40378117 |
| Id Source | org_study_id |
| Id Value | 171940 |
Countries
| Sequence: | 42813884 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55933534 | Sequence: | 55933535 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | Communication & Coping Intervention | Title | Education & Check Ins |
| Description | A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement. | Description | The comparison group receives educational materials on diabetes management and phone calls, as well as access to a secret Facebook group with daily posts on diabetes management. |
Interventions
| Sequence: | 52787544 | Sequence: | 52787545 |
| Intervention Type | Behavioral | Intervention Type | Behavioral |
| Name | Communication & Coping Intervention | Name | Education & Check Ins |
| Description | Mothers receive a treatment manual and participate in individual phone calls aimed at reducing depressive symptoms and improving the quality of parental involvement. A concurrent secret Facebook group will have daily posts to reinforce concepts. | Description | Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts. |
Design Outcomes
| Sequence: | 178527793 | Sequence: | 178527794 | Sequence: | 178527795 | Sequence: | 178527796 | Sequence: | 178527797 | Sequence: | 178527798 | Sequence: | 178527799 | Sequence: | 178527800 | Sequence: | 178527801 | Sequence: | 178527802 | Sequence: | 178527803 | Sequence: | 178527804 | Sequence: | 178527805 | Sequence: | 178527806 | Sequence: | 178527807 | Sequence: | 178527808 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Glycemic control (A1C) | Measure | Maternal depressive symptoms | Measure | Mothers' Diabetes Distress | Measure | Adolescent psychosocial functioning – parent report | Measure | Adolescent psychosocial functioning – self report | Measure | Adolescent quality of life | Measure | Diabetes-related family conflict – parent report | Measure | Diabetes-related family conflict – adolescent report | Measure | Maternal coping | Measure | Mothers' Social Support | Measure | Maternal Symptoms of Anxiety | Measure | Adolescent Diabetes Distress | Measure | Diabetes Knowledge | Measure | Parental Involvement | Measure | Adolescent Adherence | Measure | Quality of Parental Involvement |
| Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 6 months |
| Description | Hemoglobin A1c measured as part of clinic visit | Description | Depressive symptoms measured using the Patient Health Questionnaire (PHQ-9), a 9-item measure. Scores range from 0-27; scores 0-4 indicate minimal depression, scores 5-9 indicate mild depression, scores 10-14 indicate moderate depression, scores 15-19 indicate moderately severe depression, and scores 20-27 indicate severe depression. | Description | Parent Diabetes Distress Scale (PDDS) is a measure consisting of 20 items to rate diabetes-related stress for parents of children with type 1 diabetes. A mean total score will be calculated, ranging from 0-5, with higher scores indicating greater distress. | Description | Child Behavior Checklist (CBCL) is a parent-reported measure of behavior problems in children ages 6-18. The Internalizing and Externalizing broad-band scales will be used in analyses. T scores are based on age and gender, and scores of 70 or higher indicate clinically significant problems. | Description | Youth Self Report (YSR) is a measure of self-reported behavior problems in youth ages 11-18. The Internalizing and Externalizing broad-band scales will be used in analyses. T scores are based on age and gender, and scores of 70 or higher indicate clinically significant problems. | Description | Pediatric Quality of Life (PedsQL) is a self-reported measure of diabetes-related quality of life in youth. Scaled scores range from 0-100, with higher scores indicating better quality of life. | Description | Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DFCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management. Scores range from 19-57, with higher scores indicating higher levels of conflict. | Description | Diabetes-specific family conflict will be measured with the Revised Diabetes Family Conflict Scale (DFCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management. Scores range from 19-57, with higher scores indicating higher levels of conflict. | Description | Responses to stress questionnaire – type 1 diabetes – (RSQ) is a measure of coping with diabetes-related stress. Ratio scores range from .00 to 1.00, and higher scores indicate higher relative use of coping. | Description | Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale of social support from family, friends and significant others. A mean total score will be calculated, ranging from 1-7, with higher scores indicating greater perceived social support. | Description | Generalized Anxiety Disorder Scale – 7 (GADS-7) consists of 7 items measuring symptoms of anxiety. Scores range from 0-21, and scores of 10 or higher are considered clinically meaningful. | Description | Problem Area in Diabetes – Teen (PAID-T) consists of 14 items measuring adolescents' diabetes distress. Scores range from 14-84, and scores of 44 or higher are considered clinically meaningful. | Description | Revised Brief Diabetes Knowledge Test is a measure of parents' diabetes knowledge. It consists of 23 items that ask about diabetes-related information. Scores range from 0-23, with higher scores indicating greater diabetes knowledge. | Description | Collaborative Parent Involvement (CPI) is a 12-item scale completed by adolescents to assess parental involvement in diabetes care. Mean scores range from 1-5, with higher scores indicating more collaborative parental involvement. | Description | Self Care Inventory (SCI) is a 14-item measure completed by adolescents to assess their diabetes self-management behaviors. Mean scores range from 1-5, and higher scores indicate better adherence to the diabetes regimen. | Description | Mothers and adolescents will participate in a videotaped conversation, which will be scored by objective raters using the Iowa Family Interaction Rating Scales (IFIRS). The collaborative parenting composite includes the following codes: Communication; Positive Reinforcement; and Child Centered. Scores on the collaborative parenting composite range from 3-27, with higher scores indicating higher levels of collaborative parenting. The overinvolved/intrusive parenting composite includes: Parental Influence; Intrusiveness; and Lecture/Moralize. Scores on the overinvolved scale range from 3-27, with higher scores indicating higher levels of observed behavior. |
Browse Conditions
| Sequence: | 194657962 | Sequence: | 194657963 | Sequence: | 194657964 | Sequence: | 194657965 | Sequence: | 194657966 | Sequence: | 194657967 | Sequence: | 194657968 |
| Mesh Term | Diabetes Mellitus, Type 1 | Mesh Term | Diabetes Mellitus | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases | Mesh Term | Endocrine System Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases |
| Downcase Mesh Term | diabetes mellitus, type 1 | Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | endocrine system diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48604064 | Sequence: | 48604065 |
| Agency Class | OTHER | Agency Class | OTHER |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
| Name | Vanderbilt University Medical Center | Name | University of Connecticut |
Overall Officials
| Sequence: | 29446091 |
| Role | Principal Investigator |
| Name | Sarah Jaser, PhD |
| Affiliation | Vanderbilt University Medical Center |
Design Group Interventions
| Sequence: | 68569034 | Sequence: | 68569035 |
| Design Group Id | 55933534 | Design Group Id | 55933535 |
| Intervention Id | 52787544 | Intervention Id | 52787545 |
Eligibilities
| Sequence: | 30941194 |
| Gender | All |
| Minimum Age | N/A |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria:
Female caregiver of an adolescent with type 1 diabetes Exclusion Criteria: Caregiver reports minimal depressive symptoms (PHQ-9 score less than 5) |
| Gender Description | Female caregiver |
| Gender Based | True |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254279343 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2019 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 15 |
Designs
| Sequence: | 30686804 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Single |
| Outcomes Assessor Masked | True |
Responsible Parties
| Sequence: | 29053541 |
| Responsible Party Type | Principal Investigator |
| Name | Sarah Jaser |
| Title | Associate Professor |
| Affiliation | Vanderbilt University Medical Center |