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

Not Applicable

Completed

• Conditions: Glycinemia; Diabetes
• Interventions: Behavioral: Usual standard of care; Behavioral: Neuropsychological Consultation

• Registration Number: NCT03653013
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2019-07-16
• Primary Completion: 2022-08-01
• Status Verified: 2023-08
• Study Completion: 2023-08-01
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• diagnosed with type 1 diabetes and followed for their care at the NYU pediatric diabetes center
• English speaking families

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Exclusion Criteria

• not english speaking
• diagnosed with type 1 diabetes within the last 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Usual standard of care	Usual standard of care from their diabetes care team
Neuropsychological Consultation Group	Neuropsychological Consultation	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.

Primary Outcome Measures

Name	Time	Method
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)	9 Months

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States