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STEP: Social Support To Empower Parents
This study is ongoing, but not recruiting participants.
First Received: May 29, 2007   Last Updated: July 15, 2008   History of Changes
Sponsored by: University of Massachusetts
Information provided by: University of Massachusetts
ClinicalTrials.gov Identifier: NCT00480493
  Purpose

This RCT intervention provides parental social support (informational, affirmational, and emotional) using parent mentors (experienced in the management of the chronic illness) for mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent mentors provide both home visits and phone call support over the course of the first year after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention will perceive less parental concern and worry, less negative impact on the family, more perceived confidence and social support compared to those mothers and fathers not receiving the intervention.


Condition Intervention Phase
Type 1 Diabetes
Behavioral: STEP
Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by University of Massachusetts:

Estimated Enrollment: 100
Study Start Date: June 2004
Estimated Study Completion Date: June 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mothers and fathers of children 12 years and younger with type 1 diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480493

Locations
United States, Massachusetts
University of Massachusetts, Worcester
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts
Investigators
Principal Investigator: Susan Sullivan-Bolyai, DNSc CNS RN University of Massachusetts, Worcester, Graduate School of Nurisng
  More Information

No publications provided

Responsible Party: University of Massachusetts ( Susan Sullivan-Bolyai )
Study ID Numbers: 1R15-NR008391-01
Study First Received: May 29, 2007
Last Updated: July 15, 2008
ClinicalTrials.gov Identifier: NCT00480493     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009