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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK110075 | U.S. NIH Grant/Contract | View source | |
| 1R01DK110075-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of the study is to conduct a multicenter, randomized effectiveness trial of The 3Ms. The proposed study will use an effectiveness-implementation "Hybrid 1" design. In this design, the primary goal is to determine whether an intervention works in a real-world setting, but the design also answers secondary questions such as the relationship between treatment dose and treatment outcome and what factors affect the actual delivery of the intervention in the clinics (staff burden, workflow interference etc).
The study will be conducted at 3 clinics in the Detroit area (Children's Hospital of Michigan (CHM); Ascension St. John Children's Hospital; William Beaumont Children's Hospital) and 4 clinics in the Chicago area. Wayne State University (WSU) will function as the coordinating center for the trial and will be responsible for overseeing the adequacy all aspects of trial management, including recruitment, retention, data collection, data management and statistical analyses. 212 African American (AA) adolescents with type 1 diabetes and their primary caregivers will be enrolled across all sites (half will be enrolled at WSU and half at the 4 Chicago sites). Families will be randomized to one of two arms: The 3Ms intervention (parental motivation for supervision of adolescent DSM) or standard educational control. In the 3Ms condition, parents will receive a brief (10-20 minute) computer delivered intervention at three consecutive routine diabetes clinic visits that is designed to increase parental motivation to supervise adolescent diabetes management. In the control condition, parents will receive computer-delivered education materials regarding type 1 diabetes. Data collection will be completed in the diabetes clinic at baseline and then at 6, 12 and 18 months after baseline in the families' home. Data collection is completed by the adolescent and caregiver on a tablet computer and includes questionnaires to assess adolescent diabetes management, parental supervision of diabetes management, family relationships and youth quality of life. Blood will also be collected to measure HbA1c (mean blood glucose level). Medical record data will also be collected. The data analyses will be intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data will analyzed using the linear mixed effect model (LME) for repeated measures.
In addition to the clinical trial, 20 diabetes clinic staff members (5 at WSU from the CHM clinic; 15 from the Chicago clinics) will also be recruited to participate in qualitative interviews upon completion of the trial. The purpose of the interview is to identify barriers and facilitators of use of the 3Ms intervention at the level of the individual clinician, the diabetes clinic and the organization (hospital). Interviews will be audiotaped and subsequently transcribed for coding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Educational Control | No Intervention | Participants in the standard educational control group will be provided with standard care regarding type 1 diabetes management during their routine clinic visits as usual. The standard care will be consistent with diabetes education provided by each of the study sites. | |
| The 3Ms Intervention + Standard Care | Experimental | Parents will complete the first intervention session in the diabetes clinic immediately after baseline data collection and randomization. The subsequent two intervention sessions will also be conducted during regularly scheduled diabetes clinic visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The 3Ms Intervention | Behavioral | The 3 Ms is a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporates principles of Motivational Interviewing. The goal of the 3 Ms intervention is to increase caregiver motivation to supervise children's daily diabetes care. The intervention consists of 3 brief sessions that are delivered at routine diabetes clinic appointments. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | Hemoglobin A1c (HbA1c) | Baseline, 6, 13 and 18 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Regimen Adherence (Objective) | Glucose Meter (frequency of testing) | Baseline, 6 months, 13 months, and 18 months |
| Diabetes Management (Self-reported) | Diabetes Management Scale (DMS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah A Ellis, Ph.D. | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| Children's Hospital University of Illinois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40859913 | Derived | Knauft KM, Jacques-Tiura AJ, Carcone AI, Evans MA, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab MB, Ellis D. Blood Glucose Levels and Diabetes Family Conflict in Black Adolescents with Type 1 Diabetes During the COVID-19 Pandemic. Behav Med. 2026 Apr-Jun;52(2):135-149. doi: 10.1080/08964289.2025.2543265. Epub 2025 Aug 27. | |
| 38775162 | Derived | Knauft KM, Jacques-Tiura AJ, Idalski Carcone A, Evans M, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab B, Ellis DA. The moderating role of diabetes distress on the effect of a randomized eHealth intervention on glycemic control in Black adolescents with type 1 diabetes. J Pediatr Psychol. 2024 Aug 1;49(8):538-546. doi: 10.1093/jpepsy/jsae033. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Educational Care Control | Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites. |
| FG001 | The 3Ms Intervention + Standard Educational Care | The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Educational Care Control | Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites. |
| BG001 | The 3Ms Intervention + Standard Educational Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Hemoglobin A1c (HbA1c) | The analyses were intent-to-treat. All randomized participants were included in the analyses | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline, 6, 13 and 18 month follow-up |
|
1 year, 6 months
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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 | Standard Educational Care Control | Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Endocrine disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Domestic violence | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Ellis, Ph.D. | Wayne State University | 313-577-1055 | dellis@med.wayne.edu |
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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 | Mar 20, 2023 | Apr 17, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2017 | Sep 12, 2022 | ICF_001.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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|
| Baseline, 6 months, 13 months, and 18 months |
| Parental Monitoring of Diabetes Care (Self-reported) | The Parental Monitoring of Diabetes Care-Revised (PMDC-R) | Baseline, 6 months, 13 months, and 18 months |
| Diabetes- Specific Family Functioning (Self-reported) | Diabetes Family Conflict Scale (DFCS-R) | Baseline, 6 months, 13 months, and 18 months |
| Adolescent Depression (Self-reported) | Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline, 6 months, 13 months, and 18 months |
| Executive Functioning (Self-reported) | Behavior Rating Inventory of Executive Function (BRIEF) | Baseline, 6 months, 13 months, and 18 months |
| Cost Analysis (Self-reported) | EuroQol five-dimensional (EQ-5D) | Baseline, 6 months, 13 months, and 18 months |
| Diabetes Emotional Distress (Self-reported) | Problem Areas in Diabetes (PAID) | Baseline, 6 months, 13 months, and 18 months |
| Household Chaos (Self-reported) | Confusion, Hubbub, and Order Scale (CHAOS) | Baseline, 6 months, 13 months, and 18 months |
| Chicago |
| Illinois |
| 60612 |
| United States |
| UChicago Medicine Comer Children's Hospital | Chicago | Illinois | 60637 | United States |
| La Rabida Children's Hospital | Chicago | Illinois | 60649 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Ascension St. John Children's Hospital | Detroit | Michigan | 48236 | United States |
| William Beaumont Children's Hospital | Royal Oak | Michigan | 48073 | United States |
| 38593428 | Derived | Ellis D, Carcone AI, Templin T, Evans M, Weissberg-Benchell J, Buggs-Saxton C, Boucher-Berry C, Miller JL, Drossos T, Dekelbab MB. Moderating Effect of Depression on Glycemic Control in an eHealth Intervention Among Black Youth With Type 1 Diabetes: Findings From a Multicenter Randomized Controlled Trial. JMIR Diabetes. 2024 Apr 9;9:e55165. doi: 10.2196/55165. |
The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Hemoglobin A1c | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
|
|
|
| Secondary | Regimen Adherence (Objective) | Glucose Meter (frequency of testing) | Not Posted | Baseline, 6 months, 13 months, and 18 months | Participants |
| Secondary | Diabetes Management (Self-reported) | Diabetes Management Scale (DMS) | Not Posted | Baseline, 6 months, 13 months, and 18 months | Participants |
| Secondary | Parental Monitoring of Diabetes Care (Self-reported) | The Parental Monitoring of Diabetes Care-Revised (PMDC-R) | Not Posted | Baseline, 6 months, 13 months, and 18 months | Participants |
| Secondary | Diabetes- Specific Family Functioning (Self-reported) | Diabetes Family Conflict Scale (DFCS-R) | Not Posted | Baseline, 6 months, 13 months, and 18 months | Participants |
| Secondary | Adolescent Depression (Self-reported) | Patient Reported Outcomes Measurement Information System (PROMIS) | Not Posted | Baseline, 6 months, 13 months, and 18 months | Participants |
| Secondary | Executive Functioning (Self-reported) | Behavior Rating Inventory of Executive Function (BRIEF) | Not Posted | Baseline, 6 months, 13 months, and 18 months | Participants |
| Secondary | Cost Analysis (Self-reported) | EuroQol five-dimensional (EQ-5D) | Not Posted | Baseline, 6 months, 13 months, and 18 months | Participants |
| Secondary | Diabetes Emotional Distress (Self-reported) | Problem Areas in Diabetes (PAID) | Not Posted | Baseline, 6 months, 13 months, and 18 months | Participants |
| Secondary | Household Chaos (Self-reported) | Confusion, Hubbub, and Order Scale (CHAOS) | Not Posted | Baseline, 6 months, 13 months, and 18 months | Participants |
| 0 |
| 74 |
| 29 |
| 74 |
| 29 |
| 74 |
| EG001 | The 3Ms Intervention + Standard Educational Care | The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments. | 0 | 75 | 24 | 75 | 21 | 75 |
| New Non-diabetes-Related Health Problem | Surgical and medical procedures | Systematic Assessment |
|
| Blood glucose less than 50 mg/dL | Endocrine disorders | Systematic Assessment |
|
| Worsening Diabetes-Related Health Problem | Endocrine disorders | Systematic Assessment |
|
| New Psychiatric Problem | Psychiatric disorders | Systematic Assessment |
|
| New Diabetes-Related Health Problem | Endocrine disorders | Systematic Assessment |
|
| New Non-diabetes-Related Health Problem | Surgical and medical procedures | Systematic Assessment |
|
| Problem with Parent-Child Relations | Social circumstances | Systematic Assessment |
|
| Psychiatric Problem | Psychiatric disorders | Systematic Assessment |
|
| School Related Problem | Social circumstances | Systematic Assessment |
|
| Worsening Diabetes-Related Health Problem | Endocrine disorders | Systematic Assessment |
|
| New Family Problem | Social circumstances | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |