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

NCT03653013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-08-24

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Usual standard of care

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.

BEHAVIORAL

Neuropsychological Consultation

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.

Sponsors & Collaborators

Principal Investigators

  • Mary Gallagher, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-16
Primary Completion
2022-08-01
Completion
2023-08-01

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653013 on ClinicalTrials.gov