SAFIR Family Talk - Investigating the Effect of The Family Talk Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Mental Disorder, Family, Child, Parenting, Resilience, Prevention

Intervention / Treatment
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* Behavioral: Family Talk Preventive Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SAFIR Family Talk is i randomized controlled trial carried out in the capital region of Denmark. The trial examines the Family Talk intervention, developed by William Beardslee, as opposed to service as usual (SAU) in out patient clinics in the public health sector in the capital region of denmark. All participating families will be assessed at baseline, 4 months follow-up and 12 months follow-up.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Talk<br>families will receive a manualized, family-based intervention Family Talk of approximately 8 sessions with a trained, Family Talk interventionist. | Behavioral: Family Talk Preventive Intervention<br>* This is a clinician facilitated, psychoeducational preventive intervention that includes on average 8 sessions designed to improve family communication and understanding of parental mental illness, improve interpersonal relationships, and promote child resilience and utilization of social support. An important tool throughout the intervention is the logbook which the clinician uses for taking notes with each family. The logbook prescribes the planned topics to be covered in each session and the contents of the sessions are noted in the logbook by the clinicians.<br>* Other names: Beardslee's Family Intervention;|
| No Intervention: Service as usual<br>Families in this arm will not receive any intervention from the research team but they may receive other services. It is likely that many will receive two sessions of talk intervention concerning parental mental health and child well-being from professionals in the mental health sector where the parent is treated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Children's Global Assessment Scale (CGAS) | 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. | Assessment at baseline, 4 months and 12 months after baseline. | 
| Change in Family Assessment Device (FAD) (Parent-rated) | 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. | Assessment at baseline, 4 months and 12 months after baseline. | 
| Change in Parental Sense of Competency (PSOC) | A 16 item parent report questionnaire assessing overall parenting sense of competence. Each item rated on a 6-point Likert scale. A higher total score indicates a higher parenting sense of competency. | Assessment at baseline, 4 months and 12 months after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beck's Youth Inventories (BYI-II) | 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. | Assessment at baseline, 4 months and 12 months after baseline. | 
| Change in Parent-Child Communication (Child-rated) | 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. | Assessment at baseline, 4 months and 12 months after baseline. | 
| Change in Response to parents' mood | A 4-questions multiple-choice questionnaire administered to the child assessing the child's reaction to the parents' mood. | Assessment at baseline, 4 months and 12 months after baseline. | 
| Change in parental recovery (Brief INSPIRE-O) | 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. | Assessment at baseline, 4 months and 12 months after baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parental mental illness, COPMI, Intervention, Family Talk, Mental Illness, Beardslee