STEP: Social Support To Empower Parents

NCT00480493 | Completed Phase 3 Results

• 1 other identifier: 1R15NR008391-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Parent mentor contact

EXPERIMENTAL

Parent mentor provides face-to-face social support

Behavioral: STEP

Control Arm

ACTIVE COMPARATOR

Parent is given a phone contact

Behavioral: STEP

Interventions

STEP BEHAVIORAL

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

Also known as: Experimental arm: receives parent mentor support, Control arm: receives phone number of parent contact

Control Arm; Parent mentor contact

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

We did not have enough parents recruited to look at structural equation modeling.

Results Point of Contact

• Title: Susan Sullivan-Bolyai
• Organization: University of Massachusetts, Worcester

susan.sullivan-bolyai@umassmed.edu

508-856-4185

Study Officials

• Susan Sullivan-Bolyai, DNSc CNS RN

  University of Massachusetts, Worcester, Graduate School of Nurisng

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principle Investigator

Study Record Dates

• First Submitted: May 29, 2007
• First Posted: May 31, 2007
• Study Start: June 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 30, 2012
• Results First Posted: July 30, 2012

Record last verified: 2012-06

Locations

US (1)