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| Name | Class |
|---|---|
| University of Connecticut | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Communication & Coping Intervention | Experimental | A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement. |
|
| Education & Check Ins | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication & Coping Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control (A1C) | Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Depressive Symptoms | 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Female caregiver
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Jaser, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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Caregiver-adolescent dyads were enrolled and randomized. After enrollment, maternal caregiver participants were required to connect to the study Facebook account prior to randomization.
Protocol Enrollment, Number Started, and Completed reflect participants. 3 dyads were enrolled but not randomized: Two caregivers completed baseline data but did not connect to the study Facebook account.
One dyad consented and started baseline surveys but decided not to continue.
Recruited from the Children's Diabetes Program at Vanderbilt, as well as the Vanderbilt Research Notifications Distribution List.
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| ID | Title | Description |
|---|---|---|
| FG000 | Communication & Coping Intervention | A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement. Communication & Coping Intervention: 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. |
| FG001 | Education & Check Ins | 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. Education & Check Ins: Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Through Intervention |
| |||||||||||||||||||
| 3-month Data Collection |
| |||||||||||||||||||
| 6-month Data Collection |
| |||||||||||||||||||
| 12-month Data Collection |
|
Participants were maternal caregiver-adolescent dyads
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| ID | Title | Description |
|---|---|---|
| BG000 | Communication & Coping Intervention | A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement. Communication & Coping Intervention: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Caregiver age analyzed separately from adolescent age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycemic Control (A1C) | Hemoglobin A1c measured as part of clinic visit indicates the amount of glucose attached to hemoglobin. | Only adolescents participants have the A1C value. | Posted | Median | Inter-Quartile Range | Percentage of glycated hemoglobin | 12 months |
|
1 year (study period)
Only adolescent participants were assessed for adverse events. Participants' medical records were reviewed for any emergency department visits during the study project period (12 months). These were reviewed by the study endocrinologist to determine if they met the criteria for Diabetic Ketoacidosis (DKA).
None of the adverse events were related to participation in the trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Communication & Coping Intervention | A cognitive behavioral intervention for mothers of adolescents with type 1 diabetes to improve coping and the quality of parental involvement. Communication & Coping Intervention: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DKA | Endocrine disorders | Systematic Assessment | ED Visit for DKA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Indicated Self-Harm or Suicidality | Psychiatric disorders | Systematic Assessment | Child endorsed the item "I deliberately try to hurt or kill myself" or "I think about killing myself" on the Youth Self Report measure. All events were followed up by the PI (a licensed clinical psychologist) and/or the clinic social worker. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior ClinicalTrials.gov Administrator | Vanderbilt University Medical Center | 615-322-3581 | natalie.dilts@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2023 | Jul 17, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 21, 2022 | Oct 25, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
| Education & Check Ins | Behavioral | Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts. |
|
| Mothers' Diabetes Distress | 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. | 3 months |
| Adolescent Psychosocial Functioning - Parent Report | Child Behavior Checklist (CBCL) is a parent-reported measure of behavior problems in children ages 6-18. Raw scores are converted to age- and sex-normed T-Scores (mean = 50, SD = 10). Higher scores indicate greater problem behaviors. | 3 months |
| Adolescent Psychosocial Functioning - Self Report | Youth Self Report (YSR) is a measure of self-reported behavior problems in youth ages 11-18. The Child Behavior Checklist was completed by caregivers as a proxy report of adolescent's behaviors. Raw scores are converted to age- and sex-normed T-Scores (mean = 50, SD = 10). Higher scores indicate greater problem behaviors. | 3 months |
| Adolescent Quality of Life | 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. | 3 months |
| Diabetes-related Family Conflict - Parent Report | 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. | 3 months |
| Diabetes-related Family Conflict - Adolescent Report | 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. | 3 months |
| Adolescent Diabetes Distress | 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. | 3 months |
| Diabetes Knowledge | 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. | 3 months |
| Parental Involvement | 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. | 3 months |
| Adolescent Adherence | 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. | 3 months |
| Quality of Parental Involvement | 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. | 6 months |
| Adolescent |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Adolescent |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Adolescent |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Education & Check Ins | 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. Education & Check Ins: Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Participants were caregiver-adolescent dyads. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity of caregivers and adolescents were analyzed separately. | Ethnicity of caregivers and adolescents were analyzed separately. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race of caregivers and adolescents were analyzed separately. | Race of caregivers and adolescents analyzed separately. | Count of Participants | Participants |
|
| Region of Enrollment | Region of Enrollment for Caregivers only | Number | participants |
|
| Region of Enrollment | Region of Enrollment for Adolescents Only | Number | participants |
|
| Marital Status | Marital status only analyzed for caregiver participants (not adolescents). | Marital status only analyzed for caregiver participants (not adolescents). | Count of Participants | Participants |
|
| Household Income | Household income was only analyzed for caregiver participants (not adolescents) | Two caregivers did not provide information on income. | Count of Participants | Participants |
|
| Hemoglobin A1c | Hemoglobin A1c measures the amount of glucose attached to hemoglobin. It is assessed as part of regular diabetes clinic visits. The target is <7.0%. | A1c only collected from adolescents participants (not caregivers), since adolescents had type 1 diabetes. | Median | Inter-Quartile Range | percentage of glycated hemoglobin |
|
| Education & Check Ins |
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. Education & Check Ins: Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts. |
|
|
| Secondary | Maternal Depressive Symptoms | 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. | Only maternal caregiver participants completed this measure. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Mothers' Diabetes Distress | 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. | Only maternal caregiver participants completed this measure. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Adolescent Psychosocial Functioning - Parent Report | Child Behavior Checklist (CBCL) is a parent-reported measure of behavior problems in children ages 6-18. Raw scores are converted to age- and sex-normed T-Scores (mean = 50, SD = 10). Higher scores indicate greater problem behaviors. | Only maternal caregiver participants completed this measure. | Posted | Mean | Standard Deviation | T-Score | 3 months |
|
|
|
| Secondary | Adolescent Psychosocial Functioning - Self Report | Youth Self Report (YSR) is a measure of self-reported behavior problems in youth ages 11-18. The Child Behavior Checklist was completed by caregivers as a proxy report of adolescent's behaviors. Raw scores are converted to age- and sex-normed T-Scores (mean = 50, SD = 10). Higher scores indicate greater problem behaviors. | Only adolescent participants completed this measure. | Posted | Mean | Standard Deviation | T-Score | 3 months |
|
|
|
| Secondary | Adolescent Quality of Life | 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. | Only adolescent participants completed this measure. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Diabetes-related Family Conflict - Parent Report | 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. | Only maternal caregiver participants completed this measure. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Diabetes-related Family Conflict - Adolescent Report | 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. | Only adolescent participants completed this measure. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Adolescent Diabetes Distress | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Diabetes Knowledge | 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. | Only maternal caregiver participants completed this measure. | Posted | Mean | Standard Deviation | percentage of items correct | 3 months |
|
|
|
| Secondary | Parental Involvement | 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. | Only adolescent participants completed this measure. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Adolescent Adherence | 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. | Only adolescent participants completed this measure. | Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
|
|
|
| Secondary | Quality of Parental Involvement | 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. | Analysis conducted if participants had baseline and 6 month videos. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 0 |
| 75 |
| 2 |
| 75 |
| 7 |
| 75 |
| EG001 | Education & Check Ins | 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. Education & Check Ins: Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts. | 0 | 76 | 3 | 76 | 5 | 76 |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Depressive Problems |
|
| Depressive Problems |
|