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

NCT03653013 | Completed

• 1 other identifier: 18-00649
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Glycinemia

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Usual standard of care from their diabetes care team

Behavioral: Usual standard of care

Neuropsychological Consultation Group

EXPERIMENTAL

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

Interventions

Usual standard of care BEHAVIORAL

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.

Also known as: Control Group

Control Group

Neuropsychological Consultation BEHAVIORAL

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.

Neuropsychological Consultation Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mary Gallagher, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: July 16, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)