NCT03501160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 12, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

April 1, 2018

Last Update Submit

July 29, 2021

Conditions

Keywords

Regressive behaviorsChildish behaviorsSocially Inappropriate BehaviorsQualitative studySchizophrenic spectrum disorderFirst episode psychosisCaregiving experienceCaregiving distress

Outcome Measures

Primary Outcomes (1)

  • Socially inappropriate behavior in patients with first episode psychosis and its related prevailing caregiving stress and burdens.

    To identify and assess the clinical pictures of socially inappropriate behavior in first episode psychosis and its impact and related caregiving stress from caregivers' perspective by using face-to face semi-structured in-depth interview. This piece of study would explore the socially inappropriate behavior in patients with first episode psychosis. This study was expected to provide a descriptive summary and further understanding on the phenomenon interested. It would hope to arouse social attention and provide insight in future planning of social and healthcare resources in community regarding the prevailing burdens and caregiving stress perceived by caregivers of individuals who diagnosed first episode psychosis with socially inappropriate behavior in Hong Kong.

    12 Months

Interventions

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.

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Social impairment is one of the core symptoms in first episode psychosis and a part of its diagnostic criteria. Social impairment not only affects families and working performance but also creates distress and disharmony in social interactions and relationships. Despite of negative symptoms and social cognitive impairment found in patient suffering from first episode psychosis, clinicians occasionally identified socially inappropriate affectionate behavior after onset of psychotic disorder. Socially inappropriate behavior 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.

You may qualify if:

  • Active Chinese case in psychiatric specialist out-patient clinic
  • Suffering from schizophrenic spectrum disorder (ICD-10)
  • Showing socially inappropriate behavior after onset and stabilization of schizophrenic spectrum disorder

You may not qualify if:

  • Case of bipolar affective disorder, drug induced psychosis and intellectual disability
  • Case of active substance abuse
  • Case of presenting active psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North District Hospital, Hospital Authority

Sheung Shui, Hong Kong

Location

Alice Ho Miu Ling Nethersole Hospital, Hospital Authority, HKSAR

Tai Po, Hong Kong

Location

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Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse (Psychiatric)

Study Record Dates

First Submitted

April 1, 2018

First Posted

April 18, 2018

Study Start

June 12, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

July 30, 2021

Record last verified: 2021-07

Locations