Improving Metabolic Control in Diabetic Young Children

Study Overview
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Brief Summary
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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.

Official Title
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Improving Metabolic Control in Diabetic Young Children

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 7 to 11 Recently diagnosed with T1DM Treated at Mount Sinai or at North General Hospital Exclusion Criteria: Children below age 7 and above age 11 Individual with diminished mental capacity, such that they would not be able to either complete the assessments or comprehend the materials presented in the intervention, will be excluded. Individuals without sufficient command of the English language to permit participation (due to the verbal nature of the intervention and the assessment package, and the linguistic limitations of the study team).

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Behavioral: Cognitive Behavior Therapy<br> | Behavioral: Cognitive Behavioral Therapy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optimism |  | at baseline | 
| optimism |  | at 3 months | 
| optimism |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes Mellitus (T1DM), Metabolic Control, Adherence, Optimism, Parent-Child Collaboration, Prevention