SAFIR Family Talk - Investigating the Effect of The Family Talk Intervention
- Conditions
- ParentingChildResiliencePreventionMental DisorderFamily
- Interventions
- Behavioral: Family Talk Preventive Intervention
- Registration Number
- NCT05615324
- Lead Sponsor
- Mental Health Services in the Capital Region, Denmark
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
- 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.
- Not speaking Danish or English.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Family Talk Family Talk Preventive Intervention families will receive a manualized, family-based intervention Family Talk of approximately 8 sessions with a trained, Family Talk interventionist.
- Primary Outcome Measures
Name Time Method Change in Children's Global Assessment Scale (CGAS) 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) 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) 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 Outcome Measures
Name Time Method Change in Beck's Youth Inventories (BYI-II) Assessment at baseline, 4 months and 12 months after baseline. A 99 item self report measure consisting of 5 subscales to assess symptoms of Depression, Anxiety, Anger, Disruptive behaviour and Self-concept in children. Higher scores are associated with negative affect.
Change in Parent-Child Communication (Child-rated) Assessment at baseline, 4 months and 12 months after baseline. Questionnaire assessing communication between the child and the mentally ill parent. A 10 item questionnaire for children ages 8-12 and a 19 item questionnaire for children ages 13-17. Each item rated on a 6-point Likert scale. A higher score indicates better communication.
Change in Response to parents' mood Assessment at baseline, 4 months and 12 months after baseline. A 4-questions multiple-choice questionnaire administered to the child assessing the child's reaction to the parents' mood.
Change in parental recovery (Brief INSPIRE-O) Assessment at baseline, 4 months and 12 months after baseline. A 5 item self-report questionnaire completed by the parents assessing personal recovery. Each item rated on a score from 0-100. A higher score indicates better recovery.
Trial Locations
- Locations (1)
Mental Health Services in the Capital Region
🇩🇰Hellerup, Denmark