跳至主要内容
临床试验/NCT01021384
NCT01021384已完成3 期

Supporting the Well Being of Families of Young Children With Autism Spectrum

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
122
试验地点
2
主要终点
Quick Inventory of Depressive Symptoms

研究概览

简要总结

The objective of this 2 year research project is to determine whether an evidenced-based empowerment strategy, Problem Solving Education (PSE), targeted to mothers of young children with autism spectrum disorders (ASDs), promotes family well-being by decreasing the burden of maternal depressive symptoms and maternal parenting stress and improving social functioning. We propose a randomized control trial involving 140 mothers who have children <4 years with confirmed ASDs. Based on the paradigm of the IOM report on mental health prevention research that highlights the importance of targeting interventions to at-risk populations who may not meet diagnostic criteria, all mothers of young children with ASDs will be eligible to participate. Consistent with previous studies of cognitive-behavioral interventions, the mother-child pairs will be followed for 9 months. The intervention will be embedded in two settings that provide services to young children with ASDs - Early Intervention (EI) programs and specialty developmental assessment clinics. We aim to support families during a critical juncture - when they are confronted with a new diagnosis and are asked to navigate a complex service system on their children's behalf. The hypothesis of this proposal is that strengthening problem solving skills among mothers of young children with ASDs serve as an important buffer against the negative impact of life stressors, and thereby prevent and attenuate depressive symptoms and parenting stress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • all mothers of young children </ 6 with ASDs
  • mothers who speak English or Spanish

排除标准

  • Mother has psychosis
  • Mother endorses suicidal ideation
  • Mother actively using illicit drugs
  • Mother expected to leave area within 6 months

结局指标

主要结局

Quick Inventory of Depressive Symptoms

时间窗: Baseline, 1.5, 3, 4.5, 6, 7.5 & 9 months

Parenting Stress Index

时间窗: Baseline, 3, 6 & 9months

Perceived Stress Scale

时间窗: Baseline, 3, 6 & 9 months

次要结局

  • Social Problem Solving Inventory(Baseline, 3, 6 & 9 months)
  • Social Adjustment Scale Self-Report(Baseline, 3, 6 & 9 months)
  • Patient Activation Measure(Baseline, 3, 6 & 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Feinberg

Associate Professor

Boston Medical Center

研究点 (2)

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