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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
Information provided by (Responsible Party):

May 29, 2007
May 31, 2007
November 3, 2011
July 30, 2012
July 30, 2012
June 2004
May 2008   (Final data collection date for primary outcome measure)
  • 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
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Complete list of historical versions of study NCT00480493 on ClinicalTrials.gov Archive Site
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STEP: Social Support To Empower Parents
STEP: Social Support To Empower Parents
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Type 1 Diabetes
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
  • Experimental: Parent mentor contact
    Parent mentor provides face-to-face social support
    Intervention: Behavioral: STEP
  • Active Comparator: Control Arm
    Parent is given a phone contact
    Intervention: Behavioral: STEP
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mothers and fathers of children 12 years and younger with type 1 diabetes
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
1R15NR008391-01( U.S. NIH Grant/Contract )
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Susan Sullivan-Bolyai, University of Massachusetts, Worcester
University of Massachusetts, Worcester
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Principal Investigator: Susan Sullivan-Bolyai, DNSc CNS RN University of Massachusetts, Worcester, Graduate School of Nurisng
University of Massachusetts, Worcester
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP