Clinical trial NCT05615324: SAFIR Family Talk - Investigating the Effect of The Family Talk Intervention
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Disorder
Family
Child
Parenting
Resilience
Prevention
Keywords: Parental mental illness
COPMI
Intervention
Family Talk
Mental Illness
Beardslee
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Sektion for Tværsektoriel forskning - Region Hovedstaden
First posted: 2022-11-14
Enrollment: 800
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Children's Global Assessment Scale (CGAS)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Family Assessment Device (FAD) (Parent-rated)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Parenting Sense of Competency (PSOC)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
Secondary outcomes:
measure: Change in Beck's Youth Inventories (BYI-II)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Parent-Child Communication (Child-rated)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Response to parents' mood
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in parental recovery (Brief INSPIRE-O)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
Other outcomes:
measure: Change in Child-rated Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Parent-rated Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in children's Quality of Life (Kidsscreen-27)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Child and Youth Resilience Measurement (CYRM)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Guilt and Shame Questionnaire (GSQ-AMPI)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Personal and Social Performance (PSP)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Global Assessment of Functioning (GAF-S)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Parent-Child Communication (Parent-rated)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Family Talk Evaluation Questionnaire (Child-rated)
timeFrame: Assessment at 4 months after baseline where the families have completed the SAFIR Family Talk Intervention.
measure: Family Talk Evaluation Questionnaire (Parent-rated)
timeFrame: Assessment at 4 months after baseline where the families have completed the SAFIR Family Talk Intervention.
measure: Working Alliance Inventory (WAI)
timeFrame: Assessment at 4 months after baseline where the families have completed the SAFIR Family Talk Intervention.
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Assessment at 4 months after baseline where the families have completed the SAFIR Family Talk Intervention.
measure: Negative effects of the intervention assessed with the Negative Effects Questionnaire (NeQ)
timeFrame: Assessment at 4 months after baseline where the families have completed the SAFIR Family Talk Intervention.
measure: Change in child's number of days absent from school
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in The McMaster Family Assessment Device (FAD) (Children self-report)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
measure: Change in Children of Parents with Mental Illness Questionnaire (COPMI-Q)
timeFrame: Assessment at baseline, 4 months and 12 months after baseline.
Locations:
city: Hellerup
country: Denmark
facility: Mental Health Services in the Capital Region
Study officials:
affiliation: Mental Health Services in the Capital Region of Denmark
name: Anne Ranning, PhD
role: PRINCIPAL_INVESTIGATOR
References: