CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
STEPbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00480493
NCT00480493Phase 3Completed
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STEP: Social Support To Empower Parents

University of Massachusetts, Worcester·interventional·Posted May 31, 2007·Updated Jul 30, 2012

In Brief

A Phase 3 clinical trial evaluating STEP for Type 1 Diabetes. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 31, 2007
Enrollment StartJun 1, 2004
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 19.1 years ago

Interventions

STEPbehavioral

Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions