Family Routines - Healthy Families

NCT03255902 | Completed Results

• 1 other identifier: 2016-154
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the proposed study, Family Routines - Healthy Families, is to examine the feasibility and acceptability of a parenting/family routine intervention program for parents of young children, ages 2-5, with type 1 diabetes.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Effect of Intervention on Evening Glucose Control.

  Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.

  After 6 weeks of classes

Secondary Outcomes (1)

• Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value

  Pre intervention to 3 months post intervention

Study Arms (1)

Families attending parenting classes

EXPERIMENTAL

Families attended 6 parenting sessions, filled out daily glucose screens, \& questionnaires

Behavioral: Parenting classes

Interventions

Parenting classes BEHAVIORAL

Parenting Classes:The Incredible Years curriculum

Families attending parenting classes

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Self identification as primary care giver of child that fits following criteria:
• Age 2 - 5 years
• Diagnosis of Type 1 diabetes
• Most recent Hemoglobin A1c (HbA1c) \> 8.0
• Child a patient of Pediatric Endocrinology, Beaumont Children's Hospital
• English fluency

You may not qualify if:

• Cognitively impaired

Sponsors & Collaborators

• Corewell Health East: lead
• University of Michigan: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Donna Marvicsin, Nurse Practitioner, Pediatric Endocrinology
• Organization: William Beaumont Hospitals

donna.marvicsin@beaumont.org

248-568-6932

Study Officials

• Donna Marvicsin, PhD

  William Beaumont Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner, Pediatric Endocrinology

Model Details: This feasibility study will be a mixed methods non-randomized trial to examine the feasibility of combining a parent skill training intervention with a family evening routine intervention. Evidence of feasibility will include attendance, activities completed, and interviews.

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 21, 2017
• Study Start: May 24, 2016
• Primary Completion: March 1, 2017
• Study Completion: January 17, 2019
• Last Updated: July 26, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share