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| ID | Type | Description | Link |
|---|---|---|---|
| 05-0667 |
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decreased enrollment. (there are no data results for this study)
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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: Although intervention or prevention with young children with T1DM may help ameliorate problems or forestall later problems in metabolic control, a number of potential barriers to research have constrained the development of such interventions. To assess the feasibility of intervening with young children and their families, we propose to conduct an exploratory pilot study of a behavioral intervention for young children (ages 7 to 11) newly diagnosed with T1DM. The intervention, derived from the pediatric prevention work of Seligman and his colleagues, seeks to apply positive psychology principles to enhance optimism, self-efficacy, and parent-child collaboration in diabetes management, in order to improve quality of life, adherence, and metabolic control. This exploratory study will allow us to evaluate the feasibility of intervening with young children and their caretakers and to estimate intervention effect sizes in preparation for a randomized controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral: Cognitive Behavior Therapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | The treatment which incorporates cognitive restructuring and skill training, was designed to help children with diabetes and their families develop particular skills and optimistic/positive thinking style in order to facilitate better coping with the enduring demands and stress of diabetes management. The goal of the intervention was to improve the child's diabetes management both medically and psychologically by promoting optimism (positive outlook), mastery (problem-solving) and child-parent collaboration (team-work). |
| Measure | Description | Time Frame |
|---|---|---|
| adherence | at baseline | |
| adherence | at 3 months | |
| adherence | at 6 months | |
| adherence | at 9 months | |
| quality of life | at baseline | |
| quality of life | at 3 months | |
| quality of life | at 6 months | |
| quality of life | at 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| optimism | at baseline | |
| optimism | at 3 months | |
| optimism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claude Chemtob, Ph.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai School of Medicine | New York | New York | 10029-6574 | United States |
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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 |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| at 6 months |
| optimism | at 9 months |
| self-efficacy | at baseline |
| self-efficacy | at 3 months |
| self-efficacy | at 6 months |
| self-efficacy | at 9 months |
| parent-child collaboration | at baseline |
| parent-child collaboration | at 3 months |
| parent-child collaboration | at 6 months |
| parent-child collaboration | at 9 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |