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STEP: Social Support To Empower Parents (STEP)

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ClinicalTrials.gov Identifier: NCT00480493
Recruitment Status : Completed
First Posted : May 31, 2007
Results First Posted : July 30, 2012
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Susan Sullivan-Bolyai, University of Massachusetts, Worcester

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: STEP Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: STEP: Social Support To Empower Parents
Study Start Date : June 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Massachusetts
University of Massachusetts, Worcester
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Susan Sullivan-Bolyai, DNSc CNS RN University of Massachusetts, Worcester, Graduate School of Nurisng
More Information
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Responsible Party: Susan Sullivan-Bolyai, Study Principle Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00480493    
Other Study ID Numbers: 1R15NR008391-01 ( U.S. NIH Grant/Contract )
First Posted: May 31, 2007    Key Record Dates
Results First Posted: July 30, 2012
Last Update Posted: July 30, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases