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

NYU Langone Health

Status: Completed

Conditions: Diabetes; Glycinemia

Treatments: Behavioral: Usual standard of care; Behavioral: Neuropsychological Consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT03653013

18-00649

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Usual standard of care from their diabetes care team

Treatment:

Behavioral: Usual standard of care

Neuropsychological Consultation Group

Experimental group

Description:

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.

Treatment:

Behavioral: Neuropsychological Consultation