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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mental Disorder
- Sponsor
- Mental Health Services in the Capital Region, Denmark
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Change in Children's Global Assessment Scale (CGAS)
- Status
- Active, Not Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Anne Ranning
Assistant Professor
Mental Health Services in the Capital Region, Denmark
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Not speaking Danish or English.
Outcomes
Primary Outcomes
Change in Children's Global Assessment Scale (CGAS)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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.)