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临床试验/NCT00447174
NCT00447174已完成不适用

Dyadic Therapy Assessment Among Couples Coping With Traumatic Loss of a Child

Herzog Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
complicated grief symptom change

研究概览

简要总结

  1. Develop a treatment for clinically significant parental bereavement. The proposed treatment development activities include:

  2. Development of a treatment manual, associated fidelity rating forms, and training aids,

  3. Pre-testing the treatment manual with bereaved parents, and revision in consultation with treatment development experts,

  4. Conduct a randomized, wait-list control, pilot study of the proposed treatment:

  5. Measure treatment-related change in (a) complicated grief symptoms, the primary outcome variable, which will be assessed using the Inventory of Complicated Grief, and, (b) marital adjustment, the secondary outcome measure, to be assessed using the Dyadic Adjustment Scale. These outcomes will be assessed in treatment and control groups at baseline, at treatment conclusion, and at three month follow-up.

  6. Test the difference between the treatment and control groups on changes from baseline to three month follow-up on the exploratory outcome variables of PTSD, depression, social and work impairment, and quality of life

  7. Estimate effect sizes of these differences in changes in outcomes

  8. Develop a proposal for a randomized controlled trial of the treatment, based on the results of aim 2.

详细描述

RESEARCH DESIGN AND METHODS

Treatment Manual Development: Psychoeducation, Dyadic Communication in Adversity, Stress inoculation training and skills building, Cognitive processing and restructuring, Exposure through constructive narrative.Reconstruction of a positive future and relapse prevention..

WAIT-LIST CONTROL STUDY Once the treatment manual is developed, we will move immediately into pilot testing of the treatment in bereaved families. The design for this pilot study is repeated measures that compares two groups at three time points of assessment: (pre-treatment, immediately post-treatment, 3 months post-treatment). Although other outcomes will be assessed, the primary outcomes will be a measure of bereavement and a measure of marital adjustment. The three month follow-up results will be compared to the pre-treatment results using an intent-to-treat analysis with the last observation carried forward. As treatment can last from 13 to 16 sessions, the wait-list control group's welfare is of concern. We will use weekly phone conversations to check in with wait-list participants. If they appear to be deteriorating, they will be immediately referred for treatment. Wait-list participants will be offered treatment at the end of the wait-list period. It should be noted that this contact during the wait-list period represents attention provided to wait-list participants, and thus makes our design somewhat conservative. It is the primary purpose of this study to establish preliminary efficacy through investigating effect sizes associated with the treatment, and to develop a treatment manual, and other required tools to conduct a full efficacy trial.

Participants. Participants will be parents living in Israel who have lost a child, are at least 6 months post loss (following Shear), are over the age of 21, can provide informed consent, and score > 30 on the Inventory of Complicated Grief. Subjects meeting these criteria will undergo a structured clinical interview to assess for inclusion and exclusion criteria. Participants will be provided free treatment, and if needed because of income restrictions will be provided with aid to defray transportation costs to the clinic.

Subject Recruitment. We will be using various methods of recruitment, including press as well as working with partnering organizations who deal with parental bereavement , and recruitment through the trained therapists who work in different clinical settings.

研究设计

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

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Suffered the loss of a child between the ages of 0 and 25
  • Loss occurred at least 6 months prior to beginning of study
  • Score over 30 on the Inventory of Complicated Grief (ICG)
  • Spouse living with identified patient and scoring less than 30 on the ICG

排除标准

  • Parents under the age of 21
  • Presence of overt psychosis as measured with the SCID
  • Active substance abuse or dependence as measured with the SCID
  • Suicidal or homicidal ideation as measured with the SCID and the BSS
  • Suicidal or homicidal plans within the previous 6 months
  • Initiation or change in psychotropic medication within the past 3 months
  • Cognitive impairment precluding informed consent or ability to participate in treatment activities

结局指标

主要结局

complicated grief symptom change

时间窗: change from pretreatment to 3 month follow-up

Inventory of Complicated Grief

次要结局

  • marital adjustment change(change from pretreatment to 3 month follow-up)

研究者

发起方
Herzog Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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