Clinical trial NCT00439985: Improving Metabolic Control in Diabetic Young Children
Official title: Improving Metabolic Control in Diabetic Young Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus (T1DM)
Metabolic Control
Adherence
Optimism
Parent-Child Collaboration
Prevention
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-02-26
Enrollment: 23
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: : 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.


Eligibility criteria: 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).

Primary outcomes:
measure: adherence
timeFrame: at baseline
measure: adherence
timeFrame: at 3 months
measure: adherence
timeFrame: at 6 months
measure: adherence
timeFrame: at 9 months
measure: quality of life
timeFrame: at baseline
measure: quality of life
timeFrame: at 3 months
measure: quality of life
timeFrame: at 6 months
measure: quality of life
timeFrame: at 9 months
Secondary outcomes:
measure: optimism
timeFrame: at baseline
measure: optimism
timeFrame: at 3 months
measure: optimism
timeFrame: at 6 months
measure: optimism
timeFrame: at 9 months
measure: self-efficacy
timeFrame: at baseline
measure: self-efficacy
timeFrame: at 3 months
measure: self-efficacy
timeFrame: at 6 months
measure: self-efficacy
timeFrame: at 9 months
measure: parent-child collaboration
timeFrame: at baseline
measure: parent-child collaboration
timeFrame: at 3 months
measure: parent-child collaboration
timeFrame: at 6 months
measure: parent-child collaboration
timeFrame: at 9 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Claude Chemtob, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: