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STEP: Social Support To Empower Parents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susan Sullivan-Bolyai, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00480493
First received: May 29, 2007
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: STEP: Social Support To Empower Parents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Maternal Confidence Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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, Worcester
Investigators
Principal Investigator: Susan Sullivan-Bolyai, DNSc CNS RN University of Massachusetts, Worcester, Graduate School of Nurisng
  More Information

No publications provided

Responsible Party: Susan Sullivan-Bolyai, Study Principle Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00480493     History of Changes
Other Study ID Numbers: 1R15-NR008391-01
Study First Received: May 29, 2007
Results First Received: November 3, 2011
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013