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临床试验/NCT00480493
NCT00480493已完成3 期

STEP: Social Support To Empower Parents

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年6月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Maternal Confidence Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Maternal Confidence Scale

时间窗: 12 months

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

时间窗: 12 months

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

时间窗: 12 months

Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry

次要结局

未报告次要终点

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Sullivan-Bolyai

Study Principle Investigator

University of Massachusetts, Worcester

研究点 (2)

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