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STEP: Social Support To Empower Parents (STEP)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
STEP
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • University of Massachusetts, Worcester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parent mentor contact

Control Arm

Arm Description

Parent mentor provides face-to-face social support

Parent is given a phone contact

Outcomes

Primary Outcome Measures

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)
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.
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

Secondary Outcome Measures

Full Information

First Posted
May 29, 2007
Last Updated
June 21, 2012
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT00480493
Brief Title
STEP: Social Support To Empower Parents
Acronym
STEP
Official Title
STEP: Social Support To Empower Parents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent mentor contact
Arm Type
Experimental
Arm Description
Parent mentor provides face-to-face social support
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Parent is given a phone contact
Intervention Type
Behavioral
Intervention Name(s)
STEP
Other Intervention Name(s)
Experimental arm: receives parent mentor support, Control arm: receives phone number of parent contact
Intervention Description
Experimental: Minutes of parent mentor-parent participant interactions Control: Minutes of parent contact-parent participant interactions
Primary Outcome Measure Information:
Title
Maternal Confidence Scale
Description
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)
Time Frame
12 months
Title
Parent Concern
Description
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.
Time Frame
12 months
Title
Worry
Description
Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mothers and fathers of children 12 years and younger with type 1 diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Sullivan-Bolyai, DNSc CNS RN
Organizational Affiliation
University of Massachusetts, Worcester, Graduate School of Nurisng
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts, Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

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STEP: Social Support To Empower Parents

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