Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163339
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-15
Brief Title:
Evaluation of the Cultural Formulation Interview CFI
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Evaluation of the Cultural Formulation Interview CFI - An Interview Support Aiming to Enhance Assessment and Treatment Adherence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Studies show that the mental health of children may have deteriorated in recent decades In Sweden several national initiatives have been implemented to develop and strengthen interventions for childrens mental health One of these initiatives involves enhancing the first line of primary care for children with mental health issues whose mission is to provide early intervention ie support for mild to moderate mental health problems The responsibility for children with moderate to severe mental health issues lies with child and adolescent psychiatry
Research indicates that children with a migration background to a lesser extent than native-born children have contact with both the first line of mental health care and child and adolescent psychiatry There is also research showing that when newly arrived individuals do seek care they may receive poorer quality care than others and for example may be misunderstood From the perspective of equal healthcare this is a significant shortcoming In our study the investigators address differences between healthcare providers and families based on cultural factors as a possible reason for the lack of equality in healthcare
In the study the investigators aim to evaluate whether the Cultural Formulation Interview CFI improves the connection between healthcare providers and families and increases the familys involvement in treatment ultimately leading to better mental health for the child The method can be said to aim at enhancing the assessment compliance and treatment that are currently available within healthcare
Research indicates that children with a migration background to a lesser extent than native-born children have contact with both the first line of mental health care and child and adolescent psychiatry There is also research showing that when newly arrived individuals do seek care they may receive poorer quality care than others and for example may be misunderstood From the perspective of equal healthcare this is a significant shortcoming In our study the investigators address differences between healthcare providers and families based on cultural factors as a possible reason for the lack of equality in healthcare
In the study the investigators aim to evaluate whether the Cultural Formulation Interview CFI improves the connection between healthcare providers and families and increases the familys involvement in treatment ultimately leading to better mental health for the child The method can be said to aim at enhancing the assessment compliance and treatment that are currently available within healthcare
Detailed Description:
The overall aim of the project is is to evaluate the effects and experiences of the CFI which aims to be a tool for assessing mental health regardless of cultural background Developed by world-leading researchers in the field CFI is intended to support psychiatric diagnosis strengthen the alliance between healthcare providers and patients and contribute to treatment planning that both parties agree on thereby increasing adherence to treatment
The specific research questions are
Study Part 1 Quantitative Method
1 Do caregivers where the child undergoes an enhanced assessment with CFI ie standard care CFI report better working alliance and treatment credibility compared to children receiving standard care
2 Do caregivers where the child undergoes an enhanced assessment with CFI report reduced mental health issues and increased quality of life compared to children receiving standard care
Study Part 2 Qualitative Method
1 How do caregivers experience the CFI interview questions and the assessment conversation with the healthcare provider
2 Do caregivers gender and background factors such as country of birth migration experience socioeconomic conditions and occupation influence their perception of CFI
3 How do caregivers perceive the childs reaction to CFI and the assessment conversation
4 How does CFI impact caregivers understanding of healthcare and their sense of involvement
5 What is the staffs experience with CFI For example regarding understanding the patients difficulties perspectives on illness and socio-cultural context
6 How does CFI affect staffs interactions with patients and families
7 How do staff perceive the practical feasibility of CFI For example in terms of time commitment and documentation
8 How do staff perceive that information from CFI influences the diagnosis assessment and treatment of healthcare needs
CFI is developed by leading researchers in the field and is a tool intended to support psychiatric diagnosis strengthen the alliance between healthcare providers and patients and contribute to treatment planning that both parties agree on thereby increasing adherence The main interview consists of 16 open-ended questions that explore the patients perspectives and context including how social and cultural factors can influence expressions explanatory models coping strategies and expectations of healthcare The interview can be used by various professional categories such as physicians psychologists and counselors and there is flexibility for healthcare providers to reformulate and choose questions they deem relevant for the assessment The interview is intended for all patients but may be particularly useful in transcultural encounters In addition to the main interview there is also an interview targeting family members as well as 12 in-depth supplementary modules one of which is designed for school-age children and adolescents and their parents
Study Part 1 Quantitative Method
Healthcare providers ie psychologists or counselors at the participating clinics Region Stockholm will be randomly assigned to whether they will work with CFI during the study or not Those working with CFI will receive training in the method before the study begins Patients are referred to healthcare providers according to the clinics procedures often involving the provider with the shortest waiting time To evaluate the effect of CFI on treatment credibility working alliance with the healthcare provider and the childs mental health reliability and validity-tested rating scales will be used
Study Part 2 Qualitative Method
Among the caregivers who participated in the assessment with CFI some approximately 10-15 individuals will be interviewed focusing on their experiences with CFI and their interactions with the clinic Also the staff who worked with CFI will be interviewed individually or in focus groups regarding their experience with CFI n5 These interviews with caregivers and staff will be conducted by members of the EPiCSS research group Karolinska Institutet using semi-structured interview guides based on themes Interviews with caregivers and staff are offered on-site at the clinic or via phone or Zoom conducted in Swedish or if necessary in English or through an interpreter
Study Part 1 Quantitative Method
Within two-three weeks after the assessment interview CFI interview or a corresponding visit in the control group online survey data are collected regarding caregivers confidence that the intervention their child will be offered at the clinic will help them ie treatment credibility
Three months after the CFI or corresponding visit another online survey is sent to parents The survey collects data on caregivers experience of collaboration with the healthcare provider ie working alliance and caregivers ratings of the childs mental health
Study Part 2 Qualitative Method
Interviews about caregivers experiences with CFI take place within three weeks after the caregiver has been interviewed with CFI Interviews with staff occur at the earliest a couple of months after staff members start using CFI The audio from interviews both for caregivers and staff regarding the experience of CFI is recorded
The specific research questions are
Study Part 1 Quantitative Method
1 Do caregivers where the child undergoes an enhanced assessment with CFI ie standard care CFI report better working alliance and treatment credibility compared to children receiving standard care
2 Do caregivers where the child undergoes an enhanced assessment with CFI report reduced mental health issues and increased quality of life compared to children receiving standard care
Study Part 2 Qualitative Method
1 How do caregivers experience the CFI interview questions and the assessment conversation with the healthcare provider
2 Do caregivers gender and background factors such as country of birth migration experience socioeconomic conditions and occupation influence their perception of CFI
3 How do caregivers perceive the childs reaction to CFI and the assessment conversation
4 How does CFI impact caregivers understanding of healthcare and their sense of involvement
5 What is the staffs experience with CFI For example regarding understanding the patients difficulties perspectives on illness and socio-cultural context
6 How does CFI affect staffs interactions with patients and families
7 How do staff perceive the practical feasibility of CFI For example in terms of time commitment and documentation
8 How do staff perceive that information from CFI influences the diagnosis assessment and treatment of healthcare needs
CFI is developed by leading researchers in the field and is a tool intended to support psychiatric diagnosis strengthen the alliance between healthcare providers and patients and contribute to treatment planning that both parties agree on thereby increasing adherence The main interview consists of 16 open-ended questions that explore the patients perspectives and context including how social and cultural factors can influence expressions explanatory models coping strategies and expectations of healthcare The interview can be used by various professional categories such as physicians psychologists and counselors and there is flexibility for healthcare providers to reformulate and choose questions they deem relevant for the assessment The interview is intended for all patients but may be particularly useful in transcultural encounters In addition to the main interview there is also an interview targeting family members as well as 12 in-depth supplementary modules one of which is designed for school-age children and adolescents and their parents
Study Part 1 Quantitative Method
Healthcare providers ie psychologists or counselors at the participating clinics Region Stockholm will be randomly assigned to whether they will work with CFI during the study or not Those working with CFI will receive training in the method before the study begins Patients are referred to healthcare providers according to the clinics procedures often involving the provider with the shortest waiting time To evaluate the effect of CFI on treatment credibility working alliance with the healthcare provider and the childs mental health reliability and validity-tested rating scales will be used
Study Part 2 Qualitative Method
Among the caregivers who participated in the assessment with CFI some approximately 10-15 individuals will be interviewed focusing on their experiences with CFI and their interactions with the clinic Also the staff who worked with CFI will be interviewed individually or in focus groups regarding their experience with CFI n5 These interviews with caregivers and staff will be conducted by members of the EPiCSS research group Karolinska Institutet using semi-structured interview guides based on themes Interviews with caregivers and staff are offered on-site at the clinic or via phone or Zoom conducted in Swedish or if necessary in English or through an interpreter
Study Part 1 Quantitative Method
Within two-three weeks after the assessment interview CFI interview or a corresponding visit in the control group online survey data are collected regarding caregivers confidence that the intervention their child will be offered at the clinic will help them ie treatment credibility
Three months after the CFI or corresponding visit another online survey is sent to parents The survey collects data on caregivers experience of collaboration with the healthcare provider ie working alliance and caregivers ratings of the childs mental health
Study Part 2 Qualitative Method
Interviews about caregivers experiences with CFI take place within three weeks after the caregiver has been interviewed with CFI Interviews with staff occur at the earliest a couple of months after staff members start using CFI The audio from interviews both for caregivers and staff regarding the experience of CFI is recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None