Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning?

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled open label study design (study team will not be blinded) to measure whether including targeted neuropsychological consultations as part of pediatric diabetes care informs treatment and educational planning, improves glycemic control, and improves quality of life. Patients will be randomized 1:1 ratio to Group 1-Control group and Group 2-Neuropsychological consultation group.

Official Title
-----------------
Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning?

Conditions
-----------------
Diabetes, Glycinemia

Intervention / Treatment
-----------------
* Behavioral: Usual standard of care
* Behavioral: Neuropsychological Consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with type 1 diabetes and followed for their care at the NYU pediatric diabetes center English speaking families Exclusion Criteria: not english speaking diagnosed with type 1 diabetes within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Usual standard of care from their diabetes care team | Behavioral: Usual standard of care<br>* Participants will receive treatment and diabetes management as usual standard of care from their diabetes care team. They will also complete as part of the study visit: a pediatric quality of life scale(PedsQL,GenericScale and Diabetes Module) and diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study.<br>* Other names: Control Group;|
| Experimental: Neuropsychological Consultation Group<br>Children will be administered a number of neuropsychological tests. Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL, Generic Scale and Diabetes Module), diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Test, complete a parent report assessing their children's executive functioning skills at the start of the study (BRIEF-2) and they will fill out the Family Impact Module. | Behavioral: Neuropsychological Consultation<br>* Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL,Generic Scale and Diabetes Module),diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Test, complete a parent report assessing their children's executive functioning skills at the start of the study (BRIEF-2) and they will fill out the Family Impact Module.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Glycemic Control measured by assessment of glycemic control (HgbA1C) |  | 0 Months | 
| Improved Glycemic Control measured by assessment of glycemic control (HgbA1C) |  | 3 Months | 
| Improved Glycemic Control measured by assessment of glycemic control (HgbA1C) |  | 6 Months | 
| Improved Glycemic Control measured by assessment of glycemic control (HgbA1C) |  | 9 Months |