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Clinical Trials/NCT00480493
NCT00480493
Completed
Phase 3

STEP: Social Support To Empower Parents

University of Massachusetts, Worcester1 site in 1 country60 target enrollmentJune 2004
ConditionsType 1 Diabetes

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
University of Massachusetts, Worcester
Enrollment
60
Locations
1
Primary Endpoint
Maternal Confidence Scale
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
May 2008
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Susan Sullivan-Bolyai

Study Principle Investigator

University of Massachusetts, Worcester

Eligibility Criteria

Inclusion Criteria

  • Mothers and fathers of children 12 years and younger with type 1 diabetes

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (1)

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