MedDataX Logo

STEP: Social Support To Empower Parents

NCT ID: NCT00480493

Last Updated: 2012-07-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Parent mentor contact

Parent mentor provides face-to-face social support

Group Type EXPERIMENTAL

STEP

Intervention Type BEHAVIORAL

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

Control Arm

Parent is given a phone contact

Group Type ACTIVE_COMPARATOR

STEP

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

STEP

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Experimental arm: receives parent mentor support Control arm: receives phone number of parent contact

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Mothers and fathers of children 12 years and younger with type 1 diabetes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Susan Sullivan-Bolyai

Study Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan Sullivan-Bolyai, DNSc CNS RN

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester, Graduate School of Nurisng

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Massachusetts, Worcester

Worcester, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R15NR008391-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link