The Randomized Clinical Trial SAFIR FAMILY TALK: a Short Family-based Early Intervention vs. Service as Usual for Children of Parents With Mental Illness in the Capital Region of Denmark
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Change in Children's Global Assessment Scale (CGAS)
研究概览
简要总结
The goal of this clinical trial is to test the effect of the Family Talk Preventive Intervention compared to service as usual for families where a parent has mental illness. Participants are the parent with a mental illness receiving treatment from a secondary mental health service within the last two years from inclusion, their youngest child aged 7-17 years and the other parent of this child. The main questions it aims to answer are:
Is Family Talk superior to service as usual regarding improving?
- The child's level of functioning
- The parent's sense of competence
- Family functioning Participants will undergo interviews and fill out questionnaires. Half will be randomized to Family Talk and receive a manualized, family-based intervention of approximately 8 conversations with a trained, Family Talk interventionist. The other half will be randomized to service as usual which is normally two conversations with a professional in the mental health sector. The researchers will compare the two groups on child's level of functioning, parental sense of competence and family functioning.
详细描述
Children of parents with mental illness are at increased risk for mental illness themselves and therefore interventions aimed at mitigating this risk are important. The Family Talk Preventive Intervention was developed by William Beardslee in the 1980's for families with parental depression but has been widely used to treat families with other mental health conditions as well. Nevertheless, only few high-quality clinical trials exist, and the results are inconclusive.
The objective of this clinical trial is to test the effect of Family Talk Preventive Intervention compared to service as usual for families where a parent has mental illness and receiving treatment from a secondary mental health service within the last two years from inclusion. Participants are the parent with a mental illness, their youngest child aged 7-17 years and the other parent of this child. The hypothesis is that Family Talk will be superior to service as usual in improving the child's level of functioning, the parent's sense of competence and family functioning at 4 moths follow-up.
Participants will undergo interviews and fill out questionnaires at baseline, four- and twelve months follow-up assessments. Half of the families will be randomized to Family Talk and receive a manualized, family-based intervention of approximately 8 conversations with a trained, Family Talk interventionist. The other half will be randomized to service as usual which is normally two conversations with a professional in the mental health sector. The researchers will compare the two groups on child's level of functioning, parental sense of competence and family functioning and other measures including child's quality of life, communication in the family and parental personal recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The research assistants and ph.d.-students in charge of the assessment are blinded in regards to which treatment the families have received. All outcome scores are set in consensus with the other outcome assessors. In case of unblinding, it is the team setting the score, not the assessor.
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one parent must have been in contact with the secondary health care system due to a mental health condition within the last two years before inclusion.
- •The parent should have at least one child aged 7-17 years at the time of inclusion.
- •The other parent of this child may or may not have a mental health condition.
排除标准
- •Not speaking Danish or English.
结局指标
主要结局
Change in Children's Global Assessment Scale (CGAS)
时间窗: Assessment at baseline, 4 months and 12 months after baseline.
A clinician rated measurement to asses general functioning in children. Information is obtained from both the child and the parents. Scale from 1-100. High score indicates better the functioning.
Change in Family Assessment Device (FAD) (Parent-rated)
时间窗: Assessment at baseline, 4 months and 12 months after baseline.
A 60 item parent report questionnaire assessing each individual's perception of his or her family functioning. The FAD is based on a comprehensive sociological theory about different functions of a family. Scale from 1-4. Low score represents better outcome.
Change in Parenting Sense of Competency (PSOC)
时间窗: Assessment at baseline, 4 months and 12 months after baseline.
A 16 item parent report questionnaire assessing overall parenting sense of competence. Each item rated on a 6-point Likert scale. Total scale from 16-96. A higher score indicates a higher parenting sense of competency.
次要结局
- Change in Beck's Youth Inventories (BYI-II)(Assessment at baseline, 4 months and 12 months after baseline.)
- Change in Parent-Child Communication (Child-rated)(Assessment at baseline, 4 months and 12 months after baseline.)
- Change in Response to parents' mood(Assessment at baseline, 4 months and 12 months after baseline.)
- Change in parental recovery (Brief INSPIRE-O)(Assessment at baseline, 4 months and 12 months after baseline.)
研究者
Anne Ranning
Assistant Professor
Mental Health Services in the Capital Region, Denmark