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This RCT intervention provides parental social support (informational, affirmational, and emotional) using parent mentors (experienced in the management of the chronic illness) for mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent mentors provide both home visits and phone call support over the course of the first year after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention will perceive less parental concern and worry, less negative impact on the family, more perceived confidence and social support compared to those mothers and fathers not receiving the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent mentor contact | Experimental | Parent mentor provides face-to-face social support |
|
| Control Arm | Active Comparator | Parent is given a phone contact |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STEP | Behavioral | Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Confidence Scale | Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence) | 12 months |
| Parent Concern | Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care. | 12 months |
| Worry | Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry | 12 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Sullivan-Bolyai, DNSc CNS RN | University of Massachusetts, Worcester, Graduate School of Nurisng | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts, Worcester | Worcester | Massachusetts | 01655 | United States |
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Mothers recruited from 2 pediatric diabetes clinics in NE US,randomized 1:1 to either E or C. Of 118 mothers approached, 30 declined due to hectic schedules or had enough support; 28 (24%) passive no. 60 mothers completed the consent and baseline data, randomized to either E (32) or C (28).
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| ID | Title | Description |
|---|---|---|
| FG000 | Parent Mentor Contact | Parent mentor provides face-to-face, phone and/or e-mail social support |
| FG001 | Control Arm | Parent in this group receives parent contact phone number that they can call for parent support |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Parent Mentor Contact | Parent mentor provides face-to-face, phone and/or e-mail social support |
| BG001 | Control Arm | Parent in this group receives parent contact phone number that they can call for parent support |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maternal Confidence Scale | Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence) | All participants with data were analyzed | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
Adverse event data tracked for entire study (3 years).
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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 | Parent Mentor Contact | Parent mentor provides face-to-face, phone and/or e-mail social support |
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We did not have enough parents recruited to look at structural equation modeling.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Sullivan-Bolyai | University of Massachusetts, Worcester | 508-856-4185 | susan.sullivan-bolyai@umassmed.edu |
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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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|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Primary | Parent Concern | Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Primary | Worry | Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
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| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Control Arm | Parent in this group receives parent contact phone number that they can call for parent support | 0 | 28 | 0 | 28 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |