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| Name | Class |
|---|---|
| University of Nevada, Reno | OTHER |
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Behavioral family therapy, specifically focused on insuring support for the primary caregiver of a child with type one diabetes mellitus and healthy family dynamics, may improve the child's glycemic control as measured by hemoglobin A1c level (HbA1c).
The success or failure of type 1 diabetes mellitus (T1D) management in children depends not only on access to care, diabetes technologies and diabetes education, but also on the abilities of the patient and his/her family to carry out complex demands. Recent data show that family dynamics play a critical role in determining glycemic control in pediatric patients with T1D. The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with others, either a spouse or other family members. This provides a potential therapeutic target to improve outcomes for children with T1D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Family Education Modules | Experimental | Patients will receive online family education modules. |
|
| Control | No Intervention | Patients will not receive any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Learning Modules | Behavioral | The modules will include information about common family management skills: social support, problem solving, communication, and supportive behavior change strategies. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c Level | The main outcome variable will be the change in glycemic control measured as the mean HbA1c level over the two years following study enrollment. | 6, 12, 18, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral Affect Rating | 22 item assessment of the level of hostility and warmth/supportiveness that each parent has received from his or her partner over the prior month-married parents will complete; Scale range is 1 (always)-7 (never); sclae is divided into two parts, hostility and warmth/support (higher values indicate higher hostility or higher warmth/support) | At enrollment and approximately 3 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
- Families will be excluded if the child has severe underlying psychiatric, behavioral or medical conditions which could independently affect parental marital stress
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-Davis | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39432892 | Derived | Hughes Lansing A, Cohen LB, Glaser NS, Loomba LA. Feasibility and Acceptability of a Self-Guided Digital Family Skills Management Intervention for Children Newly Diagnosed With Type 1 Diabetes: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Oct 21;8:e59246. doi: 10.2196/59246. |
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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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The outcomes assessor will be masked to the participant's assignment. Others (participant, care provider, investigator) cannot be masked to assignment because one group will be receiving the behavioral health intervention and the other will not be receiving anything additional.
| Child Perception of Interparental Conflict (CPIC) | Child's assessment of conflict between parents (completed by children ages 6-18 years of married parents); scale range is 1 (best)-5 (worst), Questions 1 and 4 are reverse scored | At enrollment and approximately 3 months after enrollment |
| Family Assessment Device-General Functioning Subscale | Parent reported measure of family environment; Reverse odd questions, Average of all question: 1>x<4; Higher scores indicate more problematic perception of family function. | At enrollment and approximately 3 months after enrollment |
| Patient-Reported Outcomes Information System- Short Forms (PROMIS) | A bank of measures that examine aspects of individuals' physical, social, and mental health; Average of questions 1>x<5 (Higher scores indicated more perceived support) | At enrollment and approximately 3 months after enrollment |
| FoH-C Frequency of Help | 10 item assessment of who provides support in the home for diabetes management tasks; Average of items: 1>x>5; higher scores indicate greater frequency of help | At enrollment and approximately 3 months after enrollment |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |