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临床试验/NCT03351582
NCT03351582已完成不适用

Family Support for Grief and Communication

Ersta Sköndal University College1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年1月15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
24
试验地点
1
主要终点
Parent-Adolescent Communication Scale

研究概览

简要总结

The overall purpose of this project is to evaluate the effects of a family therapy intervention for grieving families with children. The main outcome variable is family communication.

详细描述

The intervention study will test a supportive family therapy intervention for families where a parent has died from cancer between 2013 and 2015. This will be a randomized controlled trial where participants are assigned to one of three groups using a random number sequence generated by a computer program with approximately 25 families in each intervention group.

Group one will meet with a family therapist for one 90 minute session where the main focus will be on providing information through psychoeducation on grief and communication to participants.

Group two will participate in a family therapy intervention comprised of three 90 minute sessions. participants will receive the same psychoeducation as group one and will also work with the family therapist to enhance family communication and process their grief. The 3 sessions are manual based.

Group three will be the control group and will not meet with a family therapist.

Participants will be asked if their sessions with the family therapist can be tape-recorded, but do not have to consent to this in order to participate. Approximately 6 participants need to be recorded in order to ensure that the family therapists are covering the same topics and giving the same information to all participants. In this way we can ensure that the method of intervention is the same no matter which therapist is delivering the intervention thereby validating the method of 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

性别
All
接受健康志愿者

入选标准

  • Participants are families with Children ages 3-19 who have completed our questionnaire study and have responses indicating that one or more family members have symptoms of complicated grief or a negative pattern of communication within the family. All family members who live in the same home may participate in the family therapy intervention including new partners or step children. It is up to the family to decide which family members will be included.

排除标准

  • Participants must reside in Stockholm, Sweden during data collection, speak and understand written and spoken Swedish.

结局指标

主要结局

Parent-Adolescent Communication Scale

时间窗: Change from baseline score at one month, six month, and 18 month follow up

questionnaire- scores between 20-100 with higher scores indicating better family communication.

次要结局

  • The Prolonged Grief Disorder Inventory PG-13(Change from baseline score at one month, six month, and 18 month follow up)
  • The Generalized Anxiety Disorder scale (GAD-7)(Change from baseline score at one month, six month, and 18 month follow up)
  • Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)(Change from baseline score at one month, six month, and 18 month follow up)
  • Rosenberg self-esteem scale(Change from baseline score at one month, six month, and 18 month follow up)
  • Montgomery-Åsberg Depression Rating Scale(Change from baseline score at one month, six month, and 18 month follow up)
  • The Strengths and Difficulties Questionnaire (SDQ)(Change from baseline score at one month, six month, and 18 month follow up)
  • Trauma cognitions checklist(Change from baseline score at one month, six month, and 18 month follow up)

研究者

发起方
Ersta Sköndal University College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josefin Sveen

Associate professor in medical psychology

Ersta Sköndal University College

研究点 (1)

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