STEP: Social Support To Empower Parents

Type 1 Diabetes Clinical Trial

— STEP  

Official title:

STEP: Social Support To Empower Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480493
• Other study ID #: 1R15NR008391-01
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2007
• Last updated: June 21, 2012
• Start date: June 2004
• Est. completion date: May 2008

Study information

• Verified date: June 2012
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Behavioral:
• STEP
Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions

Locations

Country	Name	City	State
United States	University of Massachusetts, Worcester	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Confidence Scale	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)	12 months	No
Primary	Parent Concern	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.	12 months	No
Primary	Worry	Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry	12 months	No