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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03653013

Enrollment

Registered

2018-08-31

Start date

2019-07-16

Completion date

2023-08-01

Last updated

2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Glycinemia

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.

Interventions

BEHAVIORALUsual 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.

BEHAVIORALNeuropsychological 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Improved Glycemic Control measured by assessment of glycemic control (HgbA1C)	0 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026