Family Routines - Healthy Families

NCT ID: NCT03255902

Last Updated: 2019-07-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-24

Study Completion Date

2019-01-17

Brief Summary

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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.

Detailed Description

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The intervention in Family Routines - Healthy Families contains an established and effective parent skills training curriculum called "The Incredible Years," uniquely integrated with a newly developed family evening routine component e.g., family dinner time and evening routine, to promote improved metabolic control. The investigator will assess outcomes during and at one week post intervention. Outcome measures will include family routine, specifically the time between the dinner and bedtime glucose check, parent bedtime decision making, and child overnight glucose control. In addition, parental quality of life and receptiveness to the intervention will be assessed.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Families attending parenting classes

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

Group Type EXPERIMENTAL

Parenting classes

Intervention Type BEHAVIORAL

Parenting Classes:The Incredible Years curriculum

Interventions

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Parenting classes

Parenting Classes:The Incredible Years curriculum

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Self identification as primary care giver of child that fits following criteria:

1. Age 2 - 5 years
2. Diagnosis of Type 1 diabetes
3. Most recent Hemoglobin A1c (HbA1c) \> 8.0
4. Child a patient of Pediatric Endocrinology, Beaumont Children's Hospital
2. English fluency

Exclusion Criteria

1. Cognitively impaired
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

William Beaumont Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Donna Marvicsin

Nurse Practitioner, Pediatric Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donna Marvicsin, PhD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Children's Hospital

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016-154

Identifier Type: -

Identifier Source: org_study_id

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