Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT03501160
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2018-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Socially Inappropriate Behaviour in People With First Episode Psychosis: A Caregivers' Perspective
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
Socially Inappropriate Behaviour in People With First Episode Psychosis: A Caregivers' Perspective
Status:
COMPLETED
Status Verified Date:
2021-07
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:
Social impairment is one of the core symptoms in first episode psychosis (FEP). Despite negative symptoms and social cognition impairment found in patient suffering from FEP, clinicians occasionally identified socially inappropriate behaviours (SIB) after onset and stabilization of psychotic disorder. It is also uncommon that some caregivers often complain about their relatives with psychosis of embarrassing and immature behaviour. SIB mainly observed in form of excessive emotional expression, childish behaviour and regressive behaviour. There is limited research focusing on this inadequate behavioural pattern in patient with first episode psychosis recently. It was worth investigating this phenomenon and gain more understanding in other comorbidity symptoms and caregiving distress arisen from this. Psychometric tests and validated assessment tools are well-developed for measuring positive symptoms, negative symptoms, neurocognitive deficits and social cognition impairment in schizophrenic patients but none of them is useful specifically for assessing SIB, and not to mention, from carer's perspective. It could be an obstacle for clinicians to investigate the phenomena of the prevalence and the impact on family in real life without any validated assessment tools or questionnaires. This qualitative study aims to identify the SIB in patients with FEP and to explore the caregiving experience and distress. Hopefully, this study may help designing a questionnaire for future exploration on this topic.
Detailed Description:
Study Design
This study will be conducted in descriptive qualitative design. Descriptive qualitative design is an eclectic and pragmatic approach. It presents comprehensive summaries of a phenomenon or events in everyday language. It studies a phenomenon to discover patterns and themes about life events intensely. Meanings of the data provided by informants should be kept as much as possible in any interpretation of the researcher. It helps to in-depth understand the experiences of caring individuals with first episode psychosis in Hong Kong. It also allows them to express their observed socially inappropriate behaviors and perceived burdens and coping strategies in their own words. It allows researches to focus on discovering the experiences and gaining insights from informants regarding a poorly understood phenomenon and develop questionnaires or interventions.
Sampling
Purposive sampling will be employed in this study. Purposive sampling allows rich and in-depth data collection as researcher purposely selecting subjects who are judged to be suitable in the population or particularly knowledgeable about the issues under study. It is particular well suited to this study as it provides a systematic way of exploring the full picture of the observed phenomenon. Using homogeneous purposive sampling can ensure selecting samples for having a shared characteristic or set of characteristics and focusing on one specific subgroup in which all the sample members are similar in a particular level or hierarchy.
The subjects will be recruited from Alice Ho Miu Ling Nethersole Hospital (AHNH) and North District Hospital (NDH) psychiatric specialist out-patient clinic. The psychiatrists working in Early Assessment Services for Young People with psychosis (EASY) team will refer the suitable Chinese cases after granted the agreement from potential subjects. The Inclusion criteria framed all target subjects were Hong Kong primary caregivers whose offspring was primary diagnosed of schizophrenic spectrum disorder with social inappropriate behavior after onset of illness. The patient should be under active care by EASY team. The cases of bipolar affective disorder and drug induced psychosis should be excluded from the study. In addition, the cases of active substance abuse and presenting active psychotic symptoms were also not suitable for the study.
Study Population Description
Socially inappropriate behavior was occasionally identified by clinicians in patient with first episode psychosis. SIB was mainly observed as social inappropriate affectionate behavior, childish behavior and regressive behavior. Clinicians observed some patient became excessively dependent on family members and displayed intimate physical contact towards family members. Such socially inappropriate behaviors may explain by frontal lobe dysfunction or deficits in theory of mind.
Socially inappropriate behaviour, as well as social disinhibition, is defined as inappropriate behaviours in term of verbal, physical or sexual acts which reflect a loss of inhibition or an inability to conform to social or cultural behavioural norms. The broad definition of SIB is regarded as physical actions with intimate or sexual behaviours which acting impulsively in motor and verbal expression. Also, SIB is also descried as a behavioural syndrome characterized by immaturity and insensitivity towards others. Research study showed SIB could be assumed to result from deficits in theory of mind as patient failed to understanding of other's mind and perspective. Various psychiatric and neurologic disorders are notable for further developing of socially inappropriate behaviours. Frontal lobe dysfunction, frontal lobe lesions, traumatic brain injury, Tourette's syndrome and frontotemporal dementia were found correlated to the development of socially inappropriate behaviours. The affected patients are unable to correctly identify moral transgressions or having impairment in judgement in their actual behaviours, excessive emotionally based acts and sexual misbehaviours.
Research studies indicated evidence in frontal lobe dysfunction is one of the major causes of SIB in the pathogenesis of schizophrenic spectrum disorder. The schizophrenic patient who suffered from frontal lobe damage demonstrated dramatic personality change, cognitive impairment and negative symptoms. The frontal system damage induced specific impairment of deficits in various aspects especially causing impulsive acts, inappropriate activities, excessive emotional expressions and childish behaviours. It is commonly to find patient shown declining in cognitive functioning, social impairment, poor motivation, lack of responsibility and impaired judgement in related to frontal lobe dysfunction.
Data Collection
Face-to face semi-structured in-depth interview will be arranged in order to explore the inappropriate social behavior and caregiver stress from caregivers. The interview will be guided by a semi-structured interview guide which specially designed for exploring clinical picture of inappropriate social and affectionate behavior and caregiving distress. The interview guide mainly consisted of specific questions and open-ended questions that encourage the subjects to talk freely in relevant topics during interview. Demographic data was also collected in the beginning of interview. Each interview will be conducted around 60 minutes until data saturated. The interview will be audio-taped with informed consent from subjects. The interview will be audio-taped and being transcribed into verbatim in text material for data analysis.
Data analysis
Data collected in the interview was audio taped and being transcribed into verbatim in text material for data analysis. Content analysis is used for analyzing the content of the collected data. It is used for analyzing the numerous findings to identify prominent themes and patterns among all collected data. It is commonly known as breaking down collected data into smaller units and grouping the similar content and concept into a sub-group with specific coding and naming. Phases and key words identified in the content of collected data which shared the common ground and meaning were interpreted and divided into related themes in order to disseminate the findings in category scheme. It determines the trends and relationship of reality by systematic coding and categorizing approach. Verbatim and related narrative materials were reviewed repeatedly by principal investigator in order to identify the underlying themes accurately and precisely.
Ethical Consideration
The study was governed and monitored by NTEC-CUHK Joint CREC. Potential subjects were invited purposively to attend the interview with full disclosure of the study. Written informed consent must be obtained from the subjects before the interview. The consent form clearly stated the essential information of study and the rights of being a research subject in Chinese. Subjects had freedom to refuse joining the study and answering questions from researchers. Subjects had the right to withdraw from the study at any time. All data and information collected was regarded as confidential and strictly accessible by responding researchers only. All data collected will be encrypted with password (electronic documents) and placed in safety place with double lock (written documents). All data and information collected in the study including audio-tape recordings and the verbatim materials will be destroyed after the completion of the study. This study do not involve any treatment or procedure differ from current treatment practice to subjects.
This study will be conducted in descriptive qualitative design. Descriptive qualitative design is an eclectic and pragmatic approach. It presents comprehensive summaries of a phenomenon or events in everyday language. It studies a phenomenon to discover patterns and themes about life events intensely. Meanings of the data provided by informants should be kept as much as possible in any interpretation of the researcher. It helps to in-depth understand the experiences of caring individuals with first episode psychosis in Hong Kong. It also allows them to express their observed socially inappropriate behaviors and perceived burdens and coping strategies in their own words. It allows researches to focus on discovering the experiences and gaining insights from informants regarding a poorly understood phenomenon and develop questionnaires or interventions.
Sampling
Purposive sampling will be employed in this study. Purposive sampling allows rich and in-depth data collection as researcher purposely selecting subjects who are judged to be suitable in the population or particularly knowledgeable about the issues under study. It is particular well suited to this study as it provides a systematic way of exploring the full picture of the observed phenomenon. Using homogeneous purposive sampling can ensure selecting samples for having a shared characteristic or set of characteristics and focusing on one specific subgroup in which all the sample members are similar in a particular level or hierarchy.
The subjects will be recruited from Alice Ho Miu Ling Nethersole Hospital (AHNH) and North District Hospital (NDH) psychiatric specialist out-patient clinic. The psychiatrists working in Early Assessment Services for Young People with psychosis (EASY) team will refer the suitable Chinese cases after granted the agreement from potential subjects. The Inclusion criteria framed all target subjects were Hong Kong primary caregivers whose offspring was primary diagnosed of schizophrenic spectrum disorder with social inappropriate behavior after onset of illness. The patient should be under active care by EASY team. The cases of bipolar affective disorder and drug induced psychosis should be excluded from the study. In addition, the cases of active substance abuse and presenting active psychotic symptoms were also not suitable for the study.
Study Population Description
Socially inappropriate behavior was occasionally identified by clinicians in patient with first episode psychosis. SIB was mainly observed as social inappropriate affectionate behavior, childish behavior and regressive behavior. Clinicians observed some patient became excessively dependent on family members and displayed intimate physical contact towards family members. Such socially inappropriate behaviors may explain by frontal lobe dysfunction or deficits in theory of mind.
Socially inappropriate behaviour, as well as social disinhibition, is defined as inappropriate behaviours in term of verbal, physical or sexual acts which reflect a loss of inhibition or an inability to conform to social or cultural behavioural norms. The broad definition of SIB is regarded as physical actions with intimate or sexual behaviours which acting impulsively in motor and verbal expression. Also, SIB is also descried as a behavioural syndrome characterized by immaturity and insensitivity towards others. Research study showed SIB could be assumed to result from deficits in theory of mind as patient failed to understanding of other's mind and perspective. Various psychiatric and neurologic disorders are notable for further developing of socially inappropriate behaviours. Frontal lobe dysfunction, frontal lobe lesions, traumatic brain injury, Tourette's syndrome and frontotemporal dementia were found correlated to the development of socially inappropriate behaviours. The affected patients are unable to correctly identify moral transgressions or having impairment in judgement in their actual behaviours, excessive emotionally based acts and sexual misbehaviours.
Research studies indicated evidence in frontal lobe dysfunction is one of the major causes of SIB in the pathogenesis of schizophrenic spectrum disorder. The schizophrenic patient who suffered from frontal lobe damage demonstrated dramatic personality change, cognitive impairment and negative symptoms. The frontal system damage induced specific impairment of deficits in various aspects especially causing impulsive acts, inappropriate activities, excessive emotional expressions and childish behaviours. It is commonly to find patient shown declining in cognitive functioning, social impairment, poor motivation, lack of responsibility and impaired judgement in related to frontal lobe dysfunction.
Data Collection
Face-to face semi-structured in-depth interview will be arranged in order to explore the inappropriate social behavior and caregiver stress from caregivers. The interview will be guided by a semi-structured interview guide which specially designed for exploring clinical picture of inappropriate social and affectionate behavior and caregiving distress. The interview guide mainly consisted of specific questions and open-ended questions that encourage the subjects to talk freely in relevant topics during interview. Demographic data was also collected in the beginning of interview. Each interview will be conducted around 60 minutes until data saturated. The interview will be audio-taped with informed consent from subjects. The interview will be audio-taped and being transcribed into verbatim in text material for data analysis.
Data analysis
Data collected in the interview was audio taped and being transcribed into verbatim in text material for data analysis. Content analysis is used for analyzing the content of the collected data. It is used for analyzing the numerous findings to identify prominent themes and patterns among all collected data. It is commonly known as breaking down collected data into smaller units and grouping the similar content and concept into a sub-group with specific coding and naming. Phases and key words identified in the content of collected data which shared the common ground and meaning were interpreted and divided into related themes in order to disseminate the findings in category scheme. It determines the trends and relationship of reality by systematic coding and categorizing approach. Verbatim and related narrative materials were reviewed repeatedly by principal investigator in order to identify the underlying themes accurately and precisely.
Ethical Consideration
The study was governed and monitored by NTEC-CUHK Joint CREC. Potential subjects were invited purposively to attend the interview with full disclosure of the study. Written informed consent must be obtained from the subjects before the interview. The consent form clearly stated the essential information of study and the rights of being a research subject in Chinese. Subjects had freedom to refuse joining the study and answering questions from researchers. Subjects had the right to withdraw from the study at any time. All data and information collected was regarded as confidential and strictly accessible by responding researchers only. All data collected will be encrypted with password (electronic documents) and placed in safety place with double lock (written documents). All data and information collected in the study including audio-tape recordings and the verbatim materials will be destroyed after the completion of the study. This study do not involve any treatment or procedure differ from current treatment practice to subjects.
Study Oversight
Has Oversight DMC:
True
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?: