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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Child; Parenting; Resilience; Mental Disorder; Prevention; Family
• Intervention / Treatment: Behavioral: Family Talk Preventive Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisbeth J Mikkelsen, Msc; Phone Number: +45 21367762; Email: lisbeth.juhl.mikkelsen@regionh.dk
• Study Contact Backup: Name: Anne Ranning, PhD; Phone Number: +45 30267320; Email: anne.ranning@regionh.dk

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Recruiting
    • Mental Health Services in the Capital Region
    • Contact: Lisbeth J Mikkelsen, Msc; Phone Number: +4521367762; Email: lisbeth.juhl.mikkelsen@regionh.dk
    • Contact: Anne Ranning, PhD; Phone Number: +4530267320; Email: anne.ranning@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Talk; 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; 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.; Other Names: Beardslee's Family Intervention
No Intervention: Service as usual; 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?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child-rated Strengths and Difficulties Questionnaire (SDQ)	A 25 item self-report questionnaire assessing developmental, behavioural and emotional problems completed by children aged 11-17. Items are rated on a three-point Likert scale (0= not true, 1= somewhat true, 2= certainly true).	Assessment at baseline, 4 months and 12 months after baseline.
Change in Parent-rated Strengths and Difficulties Questionnaire (SDQ)	A 25 item questionnaire assessing developmental, behavioural and emotional problems in children completed by the Primary-Caregiver as a respondent. Items are rated on a three-point Likert scale (0= not true, 1= somewhat true, 2= certainly true).	Assessment at baseline, 4 months and 12 months after baseline.
Change in children's Quality of Life (Kidsscreen-27)	A 27 item self-report questionnaire assessing health related Quality of Life completed by the child. Each item is rated on a 5-point Likert scale. A higher score indicates a better quality of life.	Assessment at baseline, 4 months and 12 months after baseline.
Change in Child and Youth Resilience Measurement (CYRM)	A 12 item self-report questionnaire assessing resiliency in children across a number of areas including personal skills, peer support, social skills, physical and psychological caregiving, educational and cultural. Items are rated on a 3- or 5-point Likert scale. Higher scores indicating greater resiliency.	Assessment at baseline, 4 months and 12 months after baseline.
Change in Guilt and Shame Questionnaire (GSQ-AMPI)	A 10 item self-report questionnaire completed by the child assessing feelings of guilt and shame in children of parents with mental illness. Items are rated on a 5-point Likert scale. Higher scores indicate higher feelings of guilt or shame.	Assessment at baseline, 4 months and 12 months after baseline.
Change in Personal and Social Performance (PSP)	An interviewer-rated scale assessing the Parents personal and social functioning over four domains such as social activities, relationships, self-care and aggressive behavior. The PSP provides a global score on a scale from 1-100, with lower scores indicating lower social functioning.	Assessment at baseline, 4 months and 12 months after baseline.
Change in Global Assessment of Functioning (GAF-S)	An interviewer-rated scale assessing the Parents Level of Psychiatric Symptoms. GAF-S provides a score from 1-100, with higher scores indicating better outcome.	Assessment at baseline, 4 months and 12 months after baseline.
Change in Parent-Child Communication (Parent-rated)	A 19 or 20 item questionnaire completed by the parents assessing communication between the parent and the child. Each item rated on a 5-point Likert scale. A higher score indicates better communication.	Assessment at baseline, 4 months and 12 months after baseline.
Family Talk Evaluation Questionnaire (Child-rated)	A 9 item self report questionnaire only administered to children from the SAFIR Family Talk Intervention group to assess their experience of the intervention.	Assessment at 4 months after baseline where the families have completed the SAFIR Family Talk Intervention.
Family Talk Evaluation Questionnaire (Parent-rated)	A 68 item self report questionnaire only administered to parents from the SAFIR Family Talk Intervention group. The questionnaire assess the parents experience of the intervention across a number of areas including the therapeutic alliance, client satisfaction and negative effects of the intervention. Each item rated on a 5-point Likert scale. A higher score indicates better outcome.	Assessment at 4 months after baseline where the families have completed the SAFIR Family Talk Intervention.
Working Alliance Inventory (WAI)	A 12 item questionnaire only administered to parents from the SAFIR Family Talk Intervention group to assess key aspects of the therapeutic alliance. Each item are rated on a 7-point Likert scale. A higher score indicates better outcome.	Assessment at 4 months after baseline where the families have completed the SAFIR Family Talk Intervention.
Client Satisfaction Questionnaire (CSQ-8)	A 8 item questionnaire only administered to parents from the SAFIR Family Talk Intervention group to assess the parents' experiences with different objectives in the intervention. Each item is rated on a 4-point Likert scale. A higher score indicates greater satisfaction.	Assessment at 4 months after baseline where the families have completed the SAFIR Family Talk Intervention.
Negative effects of the intervention assessed with the Negative Effects Questionnaire (NeQ)	A 21 item questionnaire only administered to parents from the SAFIR Family Talk Intervention group to investigate negative effects of the intervention. Each item is answered by "yes" or "no", where "yes" indicates better outcome.	Assessment at 4 months after baseline where the families have completed the SAFIR Family Talk Intervention.
Change in child's number of days absent from school	Number of days the child was absent from school within the last 3 months. Low number represent better outcome. Information will be obtained from registry and parents' report.	Assessment at baseline, 4 months and 12 months after baseline.
Change in Family Assessment Device (FAD) (Children self-report)	A 60 item self-report only administered to children ages 12-17 assessing family functioning. Scale from 1-4. Low score represents better outcome.	Assessment at baseline, 4 months and 12 months after baseline.
Change in Children of Parents with Mental Illness Questionnaire (COPMI-Q)	A 16 item questionnaire assessing the child's concerns regarding the mentally ill parent and thoughts on mental illness. Each item is rated on a 3-point Likert scale. A higher score indicates a more positive outcome.	Assessment at baseline, 4 months and 12 months after baseline.

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: TrygFonden, Denmark; Sektion for Tværsektoriel forskning - Region Hovedstaden
• Investigators: Principal Investigator: Anne Ranning, PhD, Mental Health Services in The Capital Region of Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): October 31, 2025

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Intervention; Mental Illness; Family Talk; Parental mental illness; COPMI; Beardslee
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 127849

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No