跳至主要内容
临床试验/NCT04107714
NCT04107714终止2 期

Starting the Conversation (STC) - Web-based Group Intervention to Support Disclosure Decisions for Parents of Children With Mental Illness

University of Ulm2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
发起方
入组人数
5
试验地点
2
主要终点
Self-stigma of parents

研究概览

简要总结

The purpose of the study is to evaluate the group-based intervention "Starting the Conversation" as a webinar in Germany. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial (RCT).

详细描述

Parents of children with mental illness often experience public and self-stigma, and keeping a child's mental illness secret is a common strategy to avoid stigma. Both secrecy and disclosure have pros and cons for parents and their children. Therefore, the decision whether, when, and to whom to disclose a child's mental illness is complex. Interventions can provide guidance for systematic consideration and a well informed decision.

The manualized peer-led group intervention "Honest, Open, Proud" (HOP) supports people with mental illness in their decision whether to disclose mental illness. Research showed positive effects of the intervention on stigma stress, disclosure-related distress and quality of life. Based on HOP, "Starting the Conversation" (STC) was developed to systematically guide parents through their decision whether and how to disclose a child's mental illness.

At the moment, there is no data regarding feasibility and efficacy of STC, but two pilot RCTs of STC are currently underway, one in Western Australia and one in Wisconsin, USA. The aim of the current study is to evaluate feasibility and efficacy of STC as a webinar in a pilot RCT in German.

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
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

  • Parent with at least one child or adolescent that (i) is aged between 6 to 17 years (ii) has a current mental disorder according to ICD-10 diagnosed by a psychiatrist or psychologist
  • Age ≥ 18 years
  • Positive screening for disclosure distress (1 item: "In general, how distressed or worried are you in terms of secrecy or disclosure of the mental illness of your child?", self-report, persons with a score ≥ 4 on a scale from 1-7 were included)
  • Online informed consent
  • Sufficient German language skills

排除标准

  • Intellectual disability of child (IQ<70, self-report)

结局指标

主要结局

Self-stigma of parents

时间窗: 8 weeks

Parent's Self-Stigma Scale (PSSS) (Eaton et al., 2018), 11 items rated from 1 to 5, sum score (range 5-55) with higher scores indicating more self-stigma.

次要结局

  • Parent-rated child quality of life(baseline, 4 weeks, 8 weeks, 16 weeks)
  • Self-stigma of parents(baseline, 4 weeks, 8 weeks, 16 weeks)
  • Social inclusion(baseline, 4 weeks, 8 weeks, 16 weeks)
  • Stigma stress related to child's mental illness(baseline, 4 weeks, 8 weeks, 16 weeks)
  • Parenting distress(baseline, 4 weeks, 8 weeks, 16 weeks)
  • Quality of life of parents(baseline, 4 weeks, 8 weeks, 16 weeks)
  • Self-esteem(baseline, 4 weeks, 8 weeks, 16 weeks)
  • Social support(baseline, 4 weeks, 8 weeks, 16 weeks)

研究者

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

Nicolas Rüsch

Professor

University of Ulm

研究点 (2)

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