STEP: Social Support To Empower Parents

Phase 3

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: STEP

• Registration Number: NCT00480493
• Lead Sponsor: University of Massachusetts, Worcester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2007-05-29
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-05-31
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2011-11-03
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-21
• Last Update Submitted: 2012-06-21
• Results First Posted: 2012-07-30
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent mentor contact	STEP	Parent mentor provides face-to-face social support
Control Arm	STEP	Parent is given a phone contact

Primary Outcome Measures

Name	Time	Method
Maternal Confidence Scale	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	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	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

Trial Locations

Locations (1)

University of Massachusetts, Worcester; 🇺🇸 Worcester, Massachusetts, United States