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STEP: Social Support To Empower Parents (STEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480493
First Posted: May 31, 2007
Last Update Posted: July 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Susan Sullivan-Bolyai, University of Massachusetts, Worcester
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: STEP: Social Support To Empower Parents

Resource links provided by NLM:


Further study details as provided by Susan Sullivan-Bolyai, University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Maternal Confidence Scale [ Time Frame: 12 months ]
    Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)

  • Parent Concern [ Time Frame: 12 months ]
    Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care.

  • Worry [ Time Frame: 12 months ]
    Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry


Enrollment: 60
Study Start Date: June 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parent mentor contact
Parent mentor provides face-to-face social support
Behavioral: STEP
Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions
Other Names:
  • Experimental arm: receives parent mentor support
  • Control arm: receives phone number of parent contact
Active Comparator: Control Arm
Parent is given a phone contact
Behavioral: STEP
Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions
Other Names:
  • Experimental arm: receives parent mentor support
  • Control arm: receives phone number of parent contact

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mothers and fathers of children 12 years and younger with type 1 diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480493


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

Responsible Party: Susan Sullivan-Bolyai, Study Principle Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00480493     History of Changes
Other Study ID Numbers: 1R15NR008391-01 ( U.S. NIH Grant/Contract )
First Submitted: May 29, 2007
First Posted: May 31, 2007
Results First Submitted: November 3, 2011
Results First Posted: July 30, 2012
Last Update Posted: July 30, 2012
Last Verified: June 2012

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